Av Eva Hofsli, Spesialist i onkologi, overlege St. Olavs Hospital, førstemananuensis NTNU, eva.hofsli@stolav.no
Eva Hofsli
Oversikten viser studier som for tiden inkluderer kreftpasienter i Norge og som er registrert i ClinicalTrials.gov (https://clinicaltrials.gov/) per 20. mai 2015. Søkeordene som er benyttet er «cancer» og «Norway». Studiene er gruppert under type cancer. Både medisinske og kirurgiske studier presenteres.
Colorectal Cancer
Nordic 8 – A Phase II Trial
NCT01867697
https://clinicaltrials.gov/ct2/show/
NCT01867697?term=NCT01867697&rank=1
Sponsor: Per Pfeiffer
Purpose: Nordic randomized phase II trial which evaluates whether biweekly cetuximab with alternating FOLFIRI and mFOLFOX6 is more effective than biweekly cetuximab with continuously FOLFIRI in patients with potential resectable KRAS wildtype metastatic colorectal cancer.
Contact: Per Pfeiffer, Professor, +45 6541 1590
per.pfeiffer@ouh.regionsyddanmark.dk
Contact: Camilla Qvortrup, MD, PhD +45 6541 4852
Study of LGX818 and Cetuximab or LGX818, BYL719, and Cetuximab in BRAF Mutant Metastatic Colorectal Cancer
NCT01719380
https://clinicaltrials.gov/ct2/show/NCT01719380?term=NCT01719380&rank=1
Sponsor: Novartis Pharmaceuticals
Purpose: This study will assess the safety and efficacy of LGX818 when combined with cetuximab or combined with cetuximab and BYL719 in patients with BRAF mutant metastatic colorectal cancer.
Contact: Novartis Pharmaceuticals, 1-888-669-6682
Modufolin® in Combination With 5-Fluorouracil Alone or Together With Oxaliplatin or Irinotecan in Colorectal Cancer
NCT02244632
Sponsor: Isofol Medical AB
https://clinicaltrials.gov/ct2/show/NCT02244632?term=NCT02244632&rank=1
Purpose: The purpose is to characterise the tolerability of Modufolin in combination with 5-FU, in combination with 5-FU and Oxaliplatin and in combination with 5-FU and Irinotecan in patients with advanced metastatic colorectal (Stage IV).
Contact: Louise Kvistgaard, +46 (0) 707 505 567
louise.kvistgaard@isofolmedical.com
A Longitudinal Study of Colorectal Cancer Patients With Metastatic Disease in Middle-Norway
NCT02395224
https://clinicaltrials.gov/ct2/show/NCT02395224?term=NCT02395224&rank=1
Sponsor: Norwegian University of Science and Technology
Purpose: The main objective is to provide original research results that may change clinical practice related to metastatic colorectal cancer. The study will evaluate treatment and patient care at different stages of the disease trajectory and the use of health care for this large group of patients.
Contact: Are Korsnes Kristensen, md, +47 72825755
are.kristensen@ntnu.no
Pilot Study of a National Screening Programme for Bowel Cancer in Norway
NCT01538550
https://clinicaltrials.gov/ct2/show/NCT01538550?term=NCT01538550&rank=1
Sponsor: Norwegian Department of Health and Social Affairs
Purpose: The Norwegian government has funded a pilot study of a national colorectal cancer screening programme. This implies initiation of a screening pilot in the catchment area for two hospitals in Norway.
Sequencing to Identify Gene Variants in Familial Colorectal Cancer
NCT01904630
https://clinicaltrials.gov/ct2/show/NCT01904630?term=NCT01904630&rank=1
Sponsor: Norwegian University of Science and Technology
Purpose: The project will use exome sequencing to search for genetic predispositions for familial colorectal cancer (CRC).
Contact: Finn Drabløs, PhD / Prof, finn.drablos@ntnu.no
Effect of the New Norwegian Food Based Dietary Guidelines on Chronic Diseases in Colorectal Cancer Survivors (NFS)
NCT01570010
https://clinicaltrials.gov/ct2/show/NCT01570010?term=NCT01570010&rank=1
Sponsor: University of Oslo
Purpose: The aim of this study to examine whether an intensive dietary intervention affects health measures and development of lifestyle diseases in colorectal cancer survivors.
Contact: Rune Blomhoff, PhD, rune.blomhoff@medisin.uio.no
Neoadjuvant Chemotherapy Versus
Standard Treatment in Patients With Locally
Advanced Colon Cancer
NCT01918527
Sponsor: Vejle Hospital
Purpose: The purpose of this study is to compare 3 cycles of neoadjuvant (preoperative) chemotherapy + operation with the standard treatment of locally advanced colon cancer, which is operation + 8 cycles of (adjuvant) chemotherapy.
Contact: Olav Dahl, MD, olav.dahl@helse-bergen.no
Liver Transplantation and Colorectal Cancer
NCT01479608
https://clinicaltrials.gov/ct2/show/NCT01479608?term=NCT01479608&rank=1
Sponsor: Oslo University Hospital
Purpose: The investigators will conduct a randomized controlled trial to explore whether liver transplantation in selected patients with liver metastases from CRC can obtain significant life extension and better health related quality of life compared to patients receiving surgical resection.
Contact: Svein Dueland, MD, 22934000 ext 47
svein.dueland@ous-hf.no
The Northern-European Initiative on Colorectal Cancer (NordICC)
NCT00883792
https://clinicaltrials.gov/ct2/show/NCT00883792?term=NCT00883792&rank=1
Sponsor: Norwegian Department of Health and Social Affairs
Purpose: NordICC is a randomised trial investigating the effect of colonoscopy on CRC incidence and mortality.
Contact: Michael Bretthauer, MD PhD
michael.bretthauer@rikshospitalet.no
Contact: Geir Hoff, MD PhD, hofg@online.no
Locally Advanced Rectal Cancer
– Exfoliated Peritoneal Tumor Cells (LARC-EX)
NCT02113384
https://clinicaltrials.gov/ct2/show/NCT02113384?term=NCT02113384&rank=1
Sponsor: Oslo University Hospital
Purpose: In this study the investigators aim to determine the presence of exfoliated tumor cells in peritoneal lavage samples from patients undergoing surgery for LARC.
Contact: Kjersti Flatmark, MD PhD, + 47 22 78 18 63
Kjersti.Flatmark@rr-research.no
Contact: Annette T Kristensen, PhD, + 47 22 78 23 12
atj@ous-hf.no
Rectal Cancer And Pre-operative Induction Therapy Followed by Dedicated Operation. The RAPIDO Trial
NCT01558921
https://clinicaltrials.gov/ct2/show/NCT01558921?term=NCT01558921&rank=1
Sponsor: University Medical Centre Groningen
Purpose: The investigators hypothesize that preoperative systemic chemotherapy combined with short-course radiotherapy (5 days) will result in an increased survival. The investigators will compare this with the standard treatment of neoadjuvant chemoradiation followed by TME surgery and optional adjuvant chemotherapy.
Contact: C. Kersten, christian.kersten@sshf.no
Contact: M. Grønlie Guren, UXARUR@ous-hf.no
Assessment of Clinically Related Outcomes and Biomarker Analysis for Translational Integration in Colorectal Cancer (ACROBATICC)
NCT01762813
https://clinicaltrials.gov/ct2/show/NCT01762813?term=NCT01762813&rank=1
Sponsor: Helse Stavanger HF
Purpose: A prospective, observational study on clinical outcomes of surgical management of primary and metastatic colorectal cancer.
Contact: Hanne R. Hagland, PhD, 92297672 ext 47
hannehagland@gmail.com
Peritoneal Surface Malignancies – Characterization, Models and Treatment Strategies (PSM)
NCT02073500
https://clinicaltrials.gov/ct2/show/NCT02073500?term=NCT02073500&rank=1
Sponsor: Oslo University Hospital
Purpose: The aim of this study is to identify biomarkers of disease recurrence and prognosis to optimize patient selection for treatment with cytoreductive surgery (CRS) with hyperthermic intraperitoneal chemotherapy (HIPEC), and through animal models to explore different treatment strategies for peritoneal surface malignancies (PSM).
Contact: Kjersti Flatmark, +47 22 78 18
Kjersti.Flatmark@rr-research.no
Contact: Annette Torgunrud Kristensen, PhD, +47 22 78 23 12 atj@ous-hf.no
Immunotoxin in Peritoneal Carcinomatosis- ImmunoPeCa Trial
NCT02219893
https://clinicaltrials.gov/ct2/show/NCT02219893?term=NCT02219893&rank=1
Sponsor: Oslo University Hospital
Purpose: The purpose of this study is through a phase I/II clinical trial to assess the safety and toxicity of intraperitoneally administered MOC31PE immunotoxin, given on the 1.postoperative day after cytoreductive surgery (CRS) and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) for peritoneal metastases from colorectal cancer (CRC).
Contact: Kjersti Flatmark, MD PhD, 22934000 ext +47
kjersti.flatmark@rr-research.no
Contact: Svein Dueland, MD PhD, 22934000 ext +47
svedue@ous-hf.no
Functional MRI of Hypoxia-mediated Rectal Cancer Aggressiveness (OxyTarget)
NCT01816607
https://clinicaltrials.gov/ct2/show/NCT01816607?term=NCT01816607&rank=1
Sponsor: University Hospital, Akershus
Purpose: The purpose of this study is to establish a reliable method for detection of rectalcancer patients with aggressive tumor at risk of metastatic disease and death by functional MRI.
Contact: Kathrine Røe, PhD, kathrine.roe@ahus.no
Contact: Anne H Ree, MD, PhD, a.h.ree@medisin.uio.no
Safe D3 Right Hemicolectomy for Cancer Through Multidetector Computed Tomography (MDCT) Angio
NCT01351714
https://clinicaltrials.gov/ct2/show/NCT01351714?term=NCT01351714&rank=1
Sponsor: Sykehuset i Vestfold HF
Purpose: This study aims to compare patients operated more radically through use of preoperative CT which maps the lymph nodes draining the affected area with patients operated in the standard way.
Contact: Dejan Ignjatovic, MD, PhD, dexexer01@hotmail.com
Contact: Bojan Stimec, MD, PhD, bojan.stimec@gmail.com
Health Related Quality of Life After Surgery and Oncological Treatment of Colorectal Liver Metastases (HQOL)
NCT01587976
https://clinicaltrials.gov/ct2/show/NCT01587976?term=NCT01587976&rank=1
Sponsor: Haukeland University Hospital
Purpose: The purpose of this trial is to study health related quality of life (HQoL)after resection of colorectal liver metastases combined with perioperative chemotherapy.
Contact: Jon-Helge Angelsen, MD, jhangelsen@gmail.com
Contact: Asgaut Viste, Professor, asgaut.viste@helse-bergen.no
Partial Liver Segment 2/3 Transplantation Study
NCT02215889
https://clinicaltrials.gov/ct2/show/NCT02215889?term=NCT02215889&rank=1
Sponsor: Oslo University Hospital
Purpose: The patients will receive hepatectomy as a 2 stage procedure. In the first surgical procedure liver segments 2-3 are removed and liver donor segments 2-3 inserted. After growth of donor segments 2-3, the remaining liver segments of the recipient are removed. The patient will at this time have only donor liver tissue in place.
Contact: Svein Dueland, MD,Ph.D. 22935789 ext +47,
svedue@ous-hf.no
ALPPS Versus PVE/PL (LIGRO)
NCT02215577
https://clinicaltrials.gov/ct2/show/NCT02215577?term=NCT02215577&rank=1
Sponsor: Regionalt Cancercentrum Väst
Purpose: Comparison of two different models of liver growth stimulation in advanced colorectal liver metastatic disease, (LIGRO Trial) enabling liver resection. Overall goal is to evaluate if the ALPPS approach is superior to PVE in enabling patients, primarily unresectable due to inadequate FLR, to be resected and reach an R0 situation with an acceptable level of complications and perioperative mortality.
Contact: Bard Rosak, MD, PhD, brosok@ous-hf.no
LOTCOL Study: Local Treatment of Colo-rectal Liver Met
NCT01867918
https://clinicaltrials.gov/ct2/show/NCT01867918?term=NCT01867918&rank=1
Sponsor: Oslo University Hospital
Purpose: In this study the investigators will include colo-rectal cancer (CRC) patients starting last line of standard palliative chemotherapy. The hypothesis is that local treatment in addition to systemic treatment will increase time to progression, progression free survival and overall survival compared to patients who receive systemic chemotherapy only.
Contact: Svein Dueland, MD PhD, 22934000 ext +47
svein.dueland@ous-hf.no
Oslo Randomized Laparoscopic Versus Open Liver Resection for Colorectal Metastases Study (Oslo-CoMet)
NCT01516710
https://clinicaltrials.gov/ct2/show/NCT01516710?term=NCT01516710&rank=1
Sponsor: Oslo University Hospital
Purpose: The purpose of the study is to compare outcomes of laparoscopic versus open liver resection for colorectal metastases in a prospective and randomized study.
Contact: Bjørn Edwin, MD, PhD, bjoedw@ous-hf.no
Contact: Åsmund A Fretland, MD, aafret@ous-hf.no
Other GI malignancies
Botulinum Toxin for Stomach Cancer Treatment
NCT01822210
https://clinicaltrials.gov/ct2/show/NCT01822210?term=NCT01822210&rank=1
Sponsor: St. Olavs Hospital
Purpose: In this pilot study Botox injections will be given by gastroscopy in both the tumor and the surrounding stomach wall. The purpose of the study is to obtain data needed to calculate sample size in a larger controlled trial.
Contact: Jon Erik Grønbech, MD, PhD, jon.e.gronbech@ntnu.no
Contact: Gøran T Andersen, MD, goran.t.andersen@ntnu.no
Anal Cancer Radiotherapy Study (ANCARAD)
NCT01937780
https://clinicaltrials.gov/ct2/show/NCT01937780?term=NCT01937780&rank=1
Sponsor: Oslo University Hospital
Purpose: This is a prospective study of patients receiving radiotherapy or chemoradiotherapy for analcancer. The main purpose of the study is to increase the knowledge of anal cancer treatment, improve treatment results, and improve anal cancer survivor care.
Contact: Marianne G Guren, MD, PhD
marianne.gronlie.guren@ous-hf.no
Contact: Morten Brændengen, MD, PhD
morten.braendengen@ous-hf.no
Breast cancer
Predictors for Response to Dose-dense Docetaxel and Epirubicin Breast Cancer (MEDOBREC)
NCT00496795
https://clinicaltrials.gov/ct2/show/NCT00496795?term=NCT00496795&rank=1
Sponsor: University of Bergen
Purpose: Molecular markers predicting response to dose dense chemotherapy with epirubicin and docetaxel in sequence for locally advanced breast cancer.
Contact: Hans Petter Eikesdal, MD PhD, +47 55 97 20 10,
hans.petter.eikesdal@helse-bergen.no
Contact: Hans P Eikesdal, MD, 004755972010
hans.petter.eikesdal@helse-bergen.no
Energy Balance and Breast cancer Aspects-II (EBBA-II)
NCT02240836
https://clinicaltrials.gov/ct2/show/NCT02240836?term=NCT02240836&rank=1
Sponsor: Oslo University Hospital
Purpose: The purpose of this study is to determine whether a 12 month exercise program comprised of strength and endurance training among newly diagnosed breast cancer patients undergoing adjuvant therapy, will influence factors associated metabolic profile, tumor growth and cardiopulmonary function.
Contact: Inger Thune, MD. PhD, inger.thune@uit.no
Magnetic Resonance (MR) Spectroscopy of Breast Cancer Tissue
NCT00184210
https://clinicaltrials.gov/ct2/show/NCT00184210?term=NCT00184210&rank=1
Sponsor: Norwegian University of Science and Technology
Purpose: Breast cancer tissue is collected from women undergoing scheduled surgery for breast cancer. The tissue specimen are analyzed by MR spectroscopy. After MR, the intact tissue specimen can be analyzed by other methods, such as histopathology.
The MR spectral profiles are compared to clinical findings such as the patients diagnosis, lymph node status and tumor size.
Contact: Beathe Sitter, PhD, +47 73 55 13 53, beathesi@ntnu.no
Contact: Tone F Bathen, PhD, +47 73 86 38 44, tone.bathen@ntnu.no
A Study of Kadcyla (Trastuzumab Emtansine) Plus Perjeta (Pertuzumab) Following Anthracyclines in Comparison With Herceptin (Trastuzumab) Plus Perjeta and a Taxane
Following Anthracyclines as Adjuvant Therapy in Patients With Operable HER2-Positive Primary Breast Cancer
NCT01966471
https://clinicaltrials.gov/ct2/show/NCT01966471?term=NCT01966471&rank=1
Sponsor: Hoffmann-La Roche
Purpose: This two-arm, randomized, open-label, multicenter study will evaluate the efficacy and safety of Kadcyla (trastuzumab emtansine, also known as T-DM1) in combination with Perjeta (pertuzumab) versus Herceptin (trastuzumab) in combination with Perjeta and a taxane as adjuvant therapy in patients with HER2-positive primary invasive breast cancer.
Contact: Reference Study ID Number: BO28407 www.roche.com/about_roche/roche_worldwide.htm
global.rochegenentechtrials@roche.com
A Phase III Study of BKM120 With Fulvestrant in Patients With HR+,HER2-, AI Treated, Locally Advanced or Metastatic Breast Cancer Who Progressed on or After mTORi (BELLE-3)
NCT01633060
https://clinicaltrials.gov/ct2/show/NCT01633060?term=NCT01633060&rank=1
Sponsor: Novartis Pharmaceuticals
Purpose: This study will evaluate whether the addition of daily BKM120 to fulvestrant is effective and safe in treating patients with HR+, HER2-, AI treated locally advanced or metastatic breast cancer who progressed on or after mTor inhibitor based treatment.
Contact: Novartis Pharmaceuticals, 1-888-669-6682
A Study Evaluating Perjeta (Pertuzumab) Combined With Herceptin (Trastuzumab) and Standard Anthracycline-based Chemotherapy in Patients With HER2-positive Locally Advanced, Inflammatory, or Early-stage Breast Cancer.
NCT02132949
https://clinicaltrials.gov/ct2/show/NCT02132949?term=NCT02132949&rank=1
Purpose: This multicenter, non-randomized, open-label, phase II study is designed to evaluate the safety and efficacy of Perjeta in combination with Herceptin and anthracycline-based chemotherapy as neoadjuvant treatment in patients with HER2-based locally advanced, inflammatory, or early-stage breast cancer.
Contact: Reference Study ID Number: WO29217
www.roche.com/about_roche/roche_worldwide.htm
global.rochegenentechtrials@roche.com
Safety of Breast Conserving Treatment in Locally Advanced Breast Cancer Receiving Neoadjuvant Treatment (NeoBCT)
NCT02017496
https://clinicaltrials.gov/ct2/show/NCT02017496?term=NCT02017496&rank=1
Sponsor: Oslo University Hospital
Purpose: The study explores the safety of breast conserving treatment (BCT)(defined as complete removal of tumor deposits) after neoadjuvant treatment for locally advanced breast cancer.
Contact: Bjørn Naume, Professor, +47 22934000
bna@ous-hf.no
Hypofractionated Loco-regional Adjuvant Radiation
NCT02384733
https://clinicaltrials.gov/ct2/show/NCT02384733?term=NCT02384733&rank=1
Sponsor: Danish Breast Cancer Cooperative Group
Purpose: The purpose of the study is to investigate the difference in late radiation morbidity between hypofractionated and normofractionated loco-regional breast irradiation irrespective of mastectomy or lumpectomy. In patients who a candidates for a boost, the boost will be provided as a simultaneous integrated boost.
Contact: Birgitte V. Offersen, MD, Ph.D, +45 7846 2547
birgoffe@rm.dk
Contact: Hanne M. Nielsen, MD, Ph.D, +45 7846 2547
haniesen@rm.dk
Prostate cancer
Curative Image Guided Radiotherapy for Prostate Cancer (RIC)
NCT01550237
https://clinicaltrials.gov/ct2/show/NCT01550237?term=NCT01550237&rank=1
Sponsor: St. Olavs Hospital
Purpose: The primary aim of the present trial is to investigate whether CT- IGRT and consequently reduced safety margins reduces the rectal side effects from curative, high dose radiotherapy in prostate cancer.
Contact: Jo Å Lund, MD PhD, +47 73867830
jo-asmund.lund@stolav.no
Contact: A Solberg, MD, +47 72825359, arne.solberg@ntnu.no
Radium-223 Dichloride and Abiraterone Acetate Compared to Placebo and Abiraterone Acetate for Men With Cancer of the Prostate When Medical or Surgical Castration Does Not Work and When the Cancer Has Spread to the Bone, Has Not Been Treated With Chemotherapy and is Causing no or Only Mild Symptoms (ERA 223)
https://clinicaltrials.gov/ct2/show/NCT02043678?term=NCT02043678&rank=1
Sponsor: Bayer
Purpose: To determine if the addition of radium-223 dichloride to standard treatment is able to prolong life and to delay events specific for prostate cancer which has spread to the bone, such as painful fractures or bone pain which needs to be treated with an X-ray machine.
Contact: Bayer Clinical Trials Contact
clinical-trials-contact@bayerhealthcare.com
Contact: For trial location information (Phone Menu Options ‘3’ or ‘4’), (+)1-888-84 22937
A Study to Assess the Benefit of Treatment Beyond Progression With Enzalutamide in Men Who Are Starting Treatment With Docetaxel After Worsening of Their Prostate Cancer When Taking Enzalutamide Alone (PRESIDE)
NCT02288247
https://clinicaltrials.gov/ct2/show/NCT02288247?term=NCT02288247&rank=1
Sponsor: Astellas Pharma Europe Ltd.
Purpose: The purpose of the study is to understand if there is benefit in continued treatment with a medicine called enzalutamide, when starting treatment with docetaxel and prednisolone (a standard chemotherapy for prostate cancer), after the prostate cancer has gotten worse when treated with enzalutamide alone.
Contact: Medical Affairs Europe, +44(0)20 3379 8000
Astellas.registration@astellas.com
Vaccine Therapy in Curative Resected Prostate Cancer Patients
NCT01197625
https://clinicaltrials.gov/ct2/show/NCT01197625?term=NCT01197625&rank=1
Sponsor: Oslo University Hospital
Purpose: In this study the investigators will include patients with high risk of PSA relapse scheduled to receive curative surgical treatment.
Contact: Svein Dueland, MD PhD, svein.dueland@radiumhospitalet.no
A Study of ARN-509 in Men With Non-Metastatic Castration-Resistant Prostate Cancer (SPARTAN)
NCT01946204
https://clinicaltrials.gov/ct2/show/NCT01946204?term=NCT01946204&rank=1
Sponsor: Aragon Pharmaceuticals, Inc.
Purpose: The purpose of this study is to evaluate the efficacy and safety of ARN-509 in adult men with high-risk non-metastatic castration-resistant prostate cancer.
Contact: JNJ.CT@sylogent.com
Pre-operative PET-MR of High Risk Prostate Cancer Patients for Assessment of Cancer Aggressiveness and Lymph Node Status
NCT02076503
https://clinicaltrials.gov/ct2/show/NCT02076503?term=NCT02076503&rank=1
Sponsor: St. Olavs Hospital
Purpose: The overall aim of the project is to improve the investigators ability to provide individually tailored treatment to prostate cancer patients. The study will include 32 men with high-risk prostate cancer, who are eligible for radical prostatectomy.
Contact: Ola Dalsegg Saether, MD, +47 73868370
ola.d.sether@ntnu.no
Contact: Tone F Bathen, PhD prof, tone.f.bathen@ntnu.no
Other urological malignancies
Adjuvant Bleomycin, Etoposide and Cisplatin (BEP) Versus Carboplatin in Stage I Seminomatous Testicular Cancer (SWENOTECA-ABC)
NCT02341989
https://clinicaltrials.gov/ct2/show/NCT02341989?term=Adjuvant+Bleomycin%2C+Etoposide+and+Cisplatin+%28BEP%29+Versus+Carboplatin+in+Stage+I+Seminomatous+Testicular+Cancer+%28SWENOTECA-ABC%29&rank=1
Sponsor: St. Olavs Hospital
Purpose: The overall aim is to investigate whether one course of adjuvant BEP have a lower relapse rate than one course of adjuvant carboplatin AUC7.
Contact: Torgrim Tandstad, MD PhD, +47 72826166
torgrim.tandstad@stolav.no
A Norwegian Observational Trial Evaluating the Treatment of Advanced Renal Cell Cancer Patients Under Treatment of Afinitor (OSAT)
NCT01390519
https://clinicaltrials.gov/ct2/show/NCT01390519?term=NCT01390519&rank=1
Sponsor: Novartis Pharmaceuticals
Purpose: This is a Norwegian prospective registration, observational study of patients with advanced renal cell cancer on Afinitor treatment after failure of one Tyrosine Kinase Inhibitor (TKI) ( e.g. sunitinib or sorafenib). The goal is to document the treatment algorithm of these patients in Norway and the efficacy and tolerability of Afinitor® in a pure 2.line setting.
Contact: Novartis Pharmaceuticals, +41-61-324-1111
A Study of MPDL3280A Compared With Chemotherapy in Patients With Locally Advanced or Metastatic Urothelial Bladder Cancer
NCT02302807
https://clinicaltrials.gov/ct2/show/NCT02302807?term=NCT02302807&rank=1
Sponsor: Hoffmann-La Roche
Purpose: This is a Phase III, global, multicenter, open-label, two-arm, randomized, controlled study designed to evaluate the efficacy and safety of MPDL3280A compared with chemotherapy in patients with locally advanced or metastatic urothelial bladder cancer (UBC) who have progressed during or following a platinum-containing regimen.
Contact: Reference Study ID Number: GO29294
www.roche.com/about_roche/roche_worldwide.htm,
888-662-6728 (U.S. Only)
global.rochegenentechtrials@roche.com
Lung cancer
AZD9291 Versus Platinum-Based Doublet-Chemotherapy in Locally Advanced or Metastatic Non-Small Cell LungCancer (AURA3)
NCT02151981
https://clinicaltrials.gov/ct2/show/NCT02151981?term=NCT02151981&rank=1
Sponsor: AstraZeneca
Purpose: A Phase III, Open Label, Randomized Study of AZD9291 versus Platinum-Based Doublet Chemotherapy for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer whose Disease has Progressed with Previous Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor Therapy and whose Tumours harbour a T790M mutation within the Epidermal Growth Factor Receptor Gene.
Contact: AstraZeneca Clinical Study Information Center
1-877-240-9479, information.center@astrazeneca.com
Contact: Cancer Study Locator, 1-877-400-4656
astrazeneca@emergingmed.com
Study of Selective BRAF Kinase Inhibitor Dabrafenib Monotherapy Twice Daily and in Combination With Dabrafenib Twice Daily and Trametinib Once Daily in Combination Therapy in Subjects With BRAF V600E Mutation Positive Metastatic (Stage IV) Non-small Cell Lung Cancer.
NCT01336634
https://clinicaltrials.gov/ct2/show/NCT01336634?term=NCT01336634&rank=1
Sponsor: GlaxoSmithKline
Purpose: This is a Phase II, non-randomized, open-label study to assess the efficacy, safety, and tolerability of dabrafenib administered as a single agent and in combination with trametinib in stage IV disease to subjects with BRAF mutant advanced non-small cell lung cancer.
Contact: US GSK Clinical Call Center, 877-379-3718
GSKClinicalSupportHD@gsk.com
A Randomized Phase 3 Study of MPDL3280A (an Engineered Anti-PDL1 Antibody) Compared to Docetaxel in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Have Failed Platinum Therapy – “OAK”
NCT02008227
https://clinicaltrials.gov/ct2/show/NCT02008227?term=NCT02008227&rank=1
Sponsor: Hoffmann-La Roche
Purpose: This global, multicenter, open-label, randomized, controlled study will evaluate the efficacy and safety of MPDL3280A compared with docetaxel in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure with platinum-containing chemotherapy.
Contact: Reference Study ID Number: GO28915 www.roche.com/about_roche/roche_worldwide.htm
888-662-6728 (U.S. Only), global.rochegenentechtrials@roche.com
Lung Function Changes After Curative Targeted Radiotherapy of Non-small-cell Lung Carcinoma
NCT02428049
https://clinicaltrials.gov/ct2/show/NCT02428049?term=NCT02428049&rank=1
Sponsor: Sykehuset i Vestfold HF
Purpose: The investigators want to assess whether curative radiotherapy for lung cancer leads to permanently reduced lung function, and to assess the predictive value of pulmonary function tests for the development of a permanent reduction in lung function after curative radiotherapy.
Contact: Janna Berg, MD, jannaberg1@gmail.com
Contact: Åslaug Helland, Ph.D., aslaug.helland@gmail.com
Pemetrexed in Advanced Non-Small-Cell Lung Cancer: at Progression vs Maintenance Therapy After Induction Chemotherapy (IDA)
NCT02004184
https://clinicaltrials.gov/ct2/show/NCT02004184?term=NCT02004184&rank=1
Sponsor: Norwegian University of Science and Technology
Purpose: The overall aim of this study is to investigate whether immediate maintenance pemetrexed therapy prolongs survival compared to observation and pemetrexed therapy at progression in patients with advanced NSCLC.
Contact: Bjørn H Grønberg, MD PhD, bjorn.h.gronberg@gmail.com
Contact: Sveinung Sørhaug, MD PhD, sveinung.sorhaug@gmail.com
Two Schedules of Hyperfractionated Thoracic Radiotherapy in Limited Disease Small Cell Lung Cancer
NCT02041845
https://clinicaltrials.gov/ct2/show/NCT02041845?term=NCT02041845&rank=1
Sponsor: Norwegian University of Science and Technology
Purpose: The aim of this study is to compare two schedules of TRT with respect to local control, progression free survival, overall survival, toxicity and health-related quality of life.
Contact: Bjørn H Grønberg, md phd, bjorn.h.gronberg@gmail.com
Randomized, Double-Blind, Multicenter, Study Comparing Veliparib Plus Carboplatin and Paclitaxel Versus Placebo Plus Carboplatin and Paclitaxel in Previously Untreated Advanced or Metastatic Squamous Non-Small Cell Lung Cancer
NCT02106546
https://clinicaltrials.gov/ct2/show/NCT02106546?term=NCT02106546&rank=1
Sponsor: AbbVie
Purpose: This is a 2 arm Phase 3 study to evaluate the safety and efficacy of the addition of veliparib plus carboplatin and paclitaxel versus the addition of placebo plus carboplatin and paclitaxel in subjects with advanced or metastatic squamous NSCLC.
Contact: Angela M Deluca, BA, +1 847-936-3354
angela.deluca@abbvie.com
Contact: Suzanne El-Hadi, MS, +1 514-832-7060
suzanne.el-hadi@abbvie.com
LDK378 Versus Chemotherapy in Previously Untreated Patients With ALK Rearranged Non-small Cell Lung Cancer
NCT01828099
https://clinicaltrials.gov/ct2/show/NCT01828099?term=NCT01828099&rank=1
Sponsor: Novartis Pharmaceuticals
Purpose: The primary purpose of the study is to compare the antitumor activity of LDK378 versus reference chemotherapy.
Contact: Novartis Pharmaceuticals, +41613241111
Identification of Predictive and Prognostic Markers for Lung Cancer With Metastases
NCT02301858
https://clinicaltrials.gov/ct2/show/NCT02301858?term=NCT02301858&rank=1
Sponsor: Sykehuset i Vestfold HF
Purpose: The project aims to compare the histopathological and molecular characteristics of tumour tissue from metastases with similar analyses of the primary tumour in the lung, where it is available.
The investigators will therefore perform analysis of blood samples if possible, to identify predictive markers in blood samples.
Contact: Janna Berg, +47 928 35 703, jannaberg1@gmail.com
A Phase I/IIa Study of UV1 Vaccination in Patients With Non Small Cell Lung Cancer (UV1-hTERT2012L)
NCT01789099
https://clinicaltrials.gov/ct2/show/NCT01789099?term=NCT01789099&rank=1
Sponsor: Ultimovacs AS
Purpose: In this study, up to 21 patients with lung cancer will receive UV1 (a therapeutic synthetic peptide vaccine) at different dose levels. The safety and tolerability of UV1 as well as immunological response will be assessed. The purpose of this study is to select a biological dose of peptides for further clinical trials.
Contact: Paal F. Brunsvig, MD PhD, +4722934739, PFB@ous-hf.no
Contact: Odd Terje Brustugun, MD PhD, +4722935795
Odd.Terje.Brustugun@ous-hf.no
Study of Efficacy and Safety of Nivolumab in Combination With EGF816 and of Nivolumab in Combination With INC280 in Patients With Previously Treated Non-small Cell Lung Cancer
NCT02323126
https://clinicaltrials.gov/ct2/show/NCT02323126?term=NCT02323126&rank=1
Sponsor: Novartis Pharmaceuticals
Purpose: To determine the efficacy and safety of Nivolumab in combination with EGF816 and of Nivolumab in combination with INC280 in previously treated NSCLC patients.
Contact: Novartis Pharmaceuticals, 1-888-669-6682
Contact: Novartis Pharmaceuticals, +41613241111 ext +41613241111
A Phase 2, Multicenter, Randomized Study of AP26113 (ALTA)
NCT02094573
https://clinicaltrials.gov/ct2/show/NCT02094573?term=NCT02094573&rank=1
Sponsor: Ariad Pharmaceuticals
Purpose: The purpose of this study is to evaluate the efficacy and safety of two different dosing regimens of AP26113 in patients with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on therapy with crizotinib.
Contact: David Kerstein, M.D., 617-494-0400
David.Kerstein@ariad.com
Contact: Frank G. Haluska, M.D., PhD, 617-494-0400
Frank.Haluska@ariad.com
Placebo Controlled Study of VS-6063 in Subjects With Malignant Pleural Mesothelioma (COMMAND)
NCT01870609
https://clinicaltrials.gov/ct2/show/NCT01870609?term=NCT01870609&rank=1
Sponsor: Verastem, Inc.
Purpose: This study is a Phase 2, randomized, double-blind, placebo-controlled, multicenter study of defactinib (VS-6063) in subjects with malignant pleural mesothelioma (MPM) who have not progressed (confirmed partial response or stable disease) following ≥ 4 cycles of treatment with pemetrexed/cisplatin or pemetrexed/carboplatin.
Contact: Dr. Odd Terje Brustugun, ot.brustugun@gmail.com
Lymphoma
Phase 3 Frontline Therapy Trial in Patients With Advanced Classical Hodgkin Lymphoma
NCT01712490
https://clinicaltrials.gov/ct2/show/NCT01712490?term=NCT01712490&rank=1
Sponsor: Millennium Pharmaceuticals, Inc.
Purpose: This open-label, randomized, 2-arm, multicenter, phase 3 study has the primary objective of comparing the modified progression-free survival (mPFS) obtained with brentuximab vedotin (ADCETRIS®) plus AVD (doxorubicin [Adriamycin], vinblastine, and dacarbazine; abbreviated A+AVD) versus that obtained with ABVD (doxorubicin [Adriamycin],bleomycin, vinblastine, and dacarbazine) for the frontline treatment of advanced classical Hodgkin lymphoma(HL).
Contact: Takeda Study Registration Call Center, +1-866-835-2233
medical@mlnm.com
Study of Nivolumab in Subjects With Relapsed or Refractory Follicular Lymphoma (FL) (CheckMate 140)
NCT02038946
https://clinicaltrials.gov/ct2/show/NCT02038946?term=NCT02038946&rank=1
Sponsor: Bristol-Myers Squibb
Purpose: The purpose of this study is to assess the clinical benefit of Nivolumab, as measured by independent radiologic review committee (IRRC)-assessed objective response rate (ORR) in subjects with FL lymphoma who have failed therapy with both CD20 antibody and an alkylating agent.
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.
A Phase I/II Study of Betalutin for Treatment of Relapsed Non-Hodgkin Lymphoma (LYMRIT-37-01)
NCT01796171
https://clinicaltrials.gov/ct2/show/NCT01796171?term=NCT01796171&rank=1
Sponsor: Nordic Nanovector
Purpose: This study is a phase I/II, open-label study in patients with relapsed CD37 positive non-Hodgkin lymphoma.
Contact: Bjørg Bolstad, +47 22 58 00 04, bb@nordicnanovector.no
A Study of the Bruton’s Tyrosine Kinase Inhibitor, PCI-32765 (Ibrutinib), in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Non-Germinal Center B-Cell Subtype of Diffuse Large B-Cell Lymphoma
NCT01855750
https://clinicaltrials.gov/ct2/show/NCT01855750?term=NCT01855750&rank=1
Sponsor: Janssen Research & Development, LLC
Purpose: The purpose of this study is to evaluate if ibrutinib administered in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) improves the clinical outcome in newly diagnosed patients with non-germinal center B-cell subtype (GCB) of diffuse large B-cell lymphoma (DLBCL).
Contact: JNJ.CT@sylogent.com
This Trial is a Randomized, Open-label Two-arm Phase III Comparative Study Assessing the Role of Involved Mediastinal Radiotherapy After Rituximab Containing Chemotherapy Regimens to Patients With Newly Diagnosed Primary Mediastinal Large B-Cell Lymphoma
NCT01599559
https://clinicaltrials.gov/ct2/show/NCT01599559?term=NCT01599559&rank=1
Sponsor: International Extranodal Lymphoma Study Group (IELSG)
Purpose: The purpose of this trial is to test whether radiation therapy is really necessary in patients where PET/CT has shown that the tumor is no longer active. Therefore we will compare radiation treatment with careful observation.
Contact: Emanuele Zucca, MD, +41 91 811 90 40, ielsg@ticino.com
Neuroendocrine tumours
Everolimus and Temozolomide in Advanced Gastroenteropancreatic Neuroendocrine Carcinoma (G3)
NCT02248012
https://clinicaltrials.gov/ct2/show/NCT02248012?term=NCT02248012&rank=1
Sponsor: Haukeland University Hospital
Purpose: To study the efficacy of everolimus combined with temozolomide as first-line treatment in advanced gastroenteropancreatic neuroendocrine carcinoma with a Ki67 of 20-55%, measured as disease control rate (non-progressive disease) at 6 months.
Contact: Halfdan Sorbye, Prof, halfdan.sorbye@helse-bergen.no
Contact: Anna Sundlov, MD, anna.sundlov@med.lu.se
Elderly
Geriatric Intervention in Frail Elderly Patients With Colorectal Cancer
NCT01321658
https://clinicaltrials.gov/ct2/show/NCT01321658?term=NCT01321658&rank=1
Sponsor: Oslo University Hospital
Purpose: The main aim of the study is to see if the number of postoperative complications in this group can be reduced by a perioperative geriatric intervention. A study of inflammation markers in serum will also be performed, with focus on identifying potential biological frailty markers.
Contact: Nina Ommundsen, MD, ninaommundsen@gmail.com
Contact: Torgeir Bruun Wyller, Dr.med, +4722118702
t.b.wyller@medisin.uio.no
Skin
A Single-Arm, Open-Label, Multicenter Clinical Trial With Nivolumab (BMS-936558) for Subjects With Histologically Confirmed Stage III (Unresectable) or Stage IV Melanoma Progressing Post Prior Treatment Containing an Anti-CTLA4 Monoclonal Antibody (CheckMate 172)
NCT02156804
https://clinicaltrials.gov/ct2/show/NCT02156804?term=NCT02156804&rank=1
Sponsor: Bristol-Myers Squibb
Purpose: The purpose of this study is to determine the rate and frequency of high-grade (CTCAE v4.0 Grade 3 or higher), treatment-related, select adverse events in subjects with histologically confirmed stage III (unresectable) or stage IV melanoma and progression post prior treatment containing an anti-Cytotoxic T Lymphocyte Antigen (CTLA-4) monoclonal antibody, treated with Nivolumab (BMS-936558) at a dose of 3 mg/kg every two weeks.
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
BRIM8: A Study of Vemurafenib Adjuvant Therapy in Patients With Resected Cutaneous BRAF Mutant Melanoma
NCT01667419
https://clinicaltrials.gov/ct2/show/NCT01667419?term=NCT01667419&rank=1
Sponsor: Hoffmann-La Roche
Purpose: This multi-center, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of vemurafenib in patients with completely resected, cutaneous BRAF-mutation positive melanoma at high risk for recurrence.
Contact: Reference Study ID Number: GO27826 www.roche.com/about_roche/roche_worldwide.htm, 888-662-6728 (U.S. Only)
global.rochegenentechtrials@roche.com
A Phase Ib/II Study of AEB071 and MEK162 in Adult Patients With Metastatic Uveal Melanoma
NCT01801358
https://clinicaltrials.gov/ct2/show/NCT01801358?term=NCT01801358&rank=1
Sponsor: Novartis Pharmaceuticals
Purpose: A phase Ib dose-escalation study of the AEB071 and MEK162 combination in adult patients with confirmed metastatic uveal melanoma.
Contact: Novartis Pharmaceuticals, 1-888-669-6682
Safety of UV1 Vaccination in Combination With Ipilimumab in Patients With Unresectable or Metastatic Malignant Melanoma
NCT02275416
Sponsor: Ultimovacs AS
Purpose: This study, with 20 patients participating, will examine the safety and tolerability for the ipilimumab/UV1 combination in patients with unresectable or metastatic malignant melanoma.
Contact: Tormod Guren, MD PhD, uxtour@ous-hf.no
Contact: Øyvind Arnesen, MD, oeyvind.arnesen@ultimovacs.com
A Phase Ib/II Study of LEE011 in Combination With MEK162 in Patients With NRAS Mutant Melanoma
NCT01781572
https://clinicaltrials.gov/ct2/show/NCT01781572?term=NCT01781572&rank=1
Sponsor: Novartis Pharmaceuticals
Purpose: In the phase Ib, the primary purpose is to establish the maximum tolerated dose (MTD)(s)/recommended phase ll dose (RP2D) and schedule of LEE011 and MEK162 orally administered combination.
Contact: Novartis Pharmaceuticals, 1-888-669-6682
Efficacy Study of Nivolumab Compared to Ipilimumab in Prevention of Recurrence of Melanoma After Complete Resection of Stage IIIb/c or Stage IV Melanoma (CheckMate 238)
NCT02388906
https://clinicaltrials.gov/ct2/show/NCT02388906?term=NCT02388906&rank=1
Sponsor: Bristol-Myers Squibb
Purpose: The purpose of this study is to determine whether nivolumab is better than ipilimumab to prevent recurrence of melanoma.
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email:
Clinical.Trials@bms.com
Whole Brain Radiotherapy Following Local Treatment of Intracranial Metastases of Melanoma (WBRTMel)
NCT01503827
https://clinicaltrials.gov/ct2/show/NCT01503827?term=NCT01503827&rank=1
Sponsor: Australia and New Zealand Melanoma Trials Group
Purpose: This trial seeks to determine if WBRT reduces the spread of brain metastases and lengthens the time to recurrence.
Contact: Kari Dolven Jacobsen, +47 22934000
kari.dolven.jacobsen@radiumhospitalet.no
Study Comparing Combination of LGX818 Plus MEK162 Versus Vemurafenib and LGX818 Monotherapy in BRAF Mutant Melanoma (COLUMBUS)
NCT01909453
https://clinicaltrials.gov/ct2/show/NCT01909453?term=NCT01909453&rank=1
Sponsor: Novartis Pharmaceuticals
Purpose: This is 2-part, randomized, open label, multi-center, parallel group, phase III study comparing the efficacy and safety of LGX818 plus MEK162 to vemurafenib and LGX818 monotherapy in patients with locally advanced unresectable or metastatic melanoma with BRAF V600 mutation.
Contact: Novartis Pharmaceuticals, 1-888-669-6682
Contact: Novartis Pharmaceuticals, +41613241111
New Versus Approved Methyl-aminolevulinate Photodynamic Therapy (MAL-PDT) Regime in Basal Cell Carcinoma (BCC)
NCT01482104
https://clinicaltrials.gov/ct2/show/NCT01482104?term=NCT01482104&rank=1
Sponsor: Norwegian University of Science and Technology
Purpose: This randomised controlled single-blinded multi-centre study primarily aims to compare BCC lesion response rate of two treatment schedules: (a) 1 single treatment of Metvix-PDT with re-treatment of non-complete responders by 3 months, and (b) the usual schedule of 2 standard Metvix(R) PDT treatments
1 week apart.
Contact: Eidi Christensen, PhD, 0047 72822050,
eidi.christensen@ntnu.no
Contact: Cato Mørk, PhD prof
Sarcoma
Surgery With or Without Radiation Therapy in Treating Patients With Previously Untreated Nonmetastatic Retroperitoneal Soft Tissue Sarcoma (STRASS)
NCT01344018
https://clinicaltrials.gov/ct2/show/NCT01344018?term=NCT01344018&rank=1
Sponsor: European Organisation for Research and Treatment of Cancer – EORTC
Purpose: This randomized phase III trial is studying radiation therapy followed by surgery to see how well it works compared with surgery alone in treating patients with previously untreated nonmetastatic retroperitoneal soft tissue sarcoma.
Contact: Stephan Stoldt, + 47 22935742,
stephan.stoldt@radiumhospitalet.no
Contact: Oyvind S. Bruland, + 47 97174004,
oyvind.bruland@medisin.uio.no
Treatment Response Evaluation in Gastrointestinal Stromal Tumor (GIST) Patients
NCT01276483
https://clinicaltrials.gov/ct2/show/NCT01276483?term=NCT01276483&rank=1
Sponsor: Oslo University Hospital
Purpose: The purpose of this study is to compare sensitivity, specificity and accuracy of PET, DW MRI and CT separately and combined for the evaluation of treatment response and progression-free survival in patients with GIST.
Contact: Mona-Elisabeth Revheim, MD, +4723070840
mona.elisabeth.revheim@ous-hf.no
Contact: Therese Seierstad, PhD, +4722781237, therese@radium.uio.no
Head and neck cancer
A Study of Pembrolizumab (MK-3475) for First Line Treatment of Recurrent or Metastatic Squamous Cell Cancer of the Head and Neck (MK-3475-048/KEYNOTE-048)
NCT02358031
https://clinicaltrials.gov/ct2/show/NCT02358031?term=NCT02358031&rank=1
Sponsor: Merck Sharp & Dohme Corp.
Purpose: The primary study hypothesis is that pembrolizumab prolongs progression free survival compared to standard treatment.
Contact: Henning Hoyte, 47 32 20 75 20
Rehabilitation for Head and Neck Cancer
NCT02439892
https://clinicaltrials.gov/ct2/show/NCT02439892?term=NCT02439892&rank=1
Sponsor: Norwegian University of Science and Technology
Purpose: The primary aim of this pilot randomised trial is to assess feasibility, evaluate patient experiences and assess preliminary effects on muscle mass, physical function, nutritional status and quality of life of rehabilitation interventions during and after radiotherapy (RT).
Contact: Jon Arne Sandmael, +47 72 40 95 00
Jon.Arne.Myhre.Sandmal@lhl-klinikkene.no
Contact: Guro B Stene, PhD, pusterommet@stolav.no
Other
Radiation Induced Cystitis Treated With Hyperbaric Oxygen – A Randomized Controlled Trial (RICH-ART)
NCT01659723
https://clinicaltrials.gov/ct2/show/NCT01659723?term=NCT01659723&rank=1
Sponsor: Göteborg University
Purpose: The primary objective of this study is to assess the relief of symptoms after Hyperbaric Oxygen Therapy (HBOT) in patients with late radiation cystitis by having Expanded Prostate cancer Index
Composite (EPIC)symptom estimation scale as primary variable.
Contact: Guro Vaagbø, MD, +47 55973974,
guro.vaagbo@helse-bergen.no
Effectiveness of Ketamine in Malignant Neuropathic Pain Relief (KETA-1)
NCT01951911
https://clinicaltrials.gov/ct2/show/NCT01951911?term=NCT01951911&rank=1
Sponsor: Haukeland University Hospital
Purpose: To see whether the addition of low-dose ketamine to a subcutaneous morphine infusion improves analgesia in patients with neuropathic cancer pain.
Contact: Meysan Hurmuzlu, M.D. PhD., 004755977320
mhur@helse-bergen.no
Contact: Rae Frances Bell, M.D. PhD., 004755977320
rae.bell@helse-bergen.no
Group-based or Individual Information About Disease and Treatment Plan
NCT01699672
https://clinicaltrials.gov/ct2/show/NCT01699672?term=NCT01699672&rank=1
Sponsor: Norwegian University of Science and Technology
Purpose: The main aim of the current study is to investigate whether the addition of a standardized,group-based educational program to the information provided by health care personnel improves cancer patients’ knowledge level about their disease, planned treatment and common side-effects of the treatment.
Contact: Ola Berger, MD, 004797519419, ola.berger@ntnu.no
Contact: Bjørn H Grønberg, MD, PhD, 0047297878, bjorn.h.gronberg@gmail.com
Dose Escalation Study of LTX-315 in Patients With Transdermally Accessible Tumours
NCT01986426
https://clinicaltrials.gov/ct2/show/NCT01986426?term=NCT01986426&rank=1
Sponsor: Lytix Biopharma AS Purpose
Purpose: The study will assess the safety, PK and efficacy of different dosing regimens of LTX-315; a lytic-peptide that induces long-term anti-cancer immune responses.
Contact: Wenche M Olsen, PhD, w.m.olsen@lytixbiopharma.com
Contact: Berit Nicolaisen, berit.nicolaisen@lytixbiopharma.com
Advanced tumors
N-of-1 Trial: Actionable Target Identification in Metastatic Cancer for Palliative Systemic Therapy (MetAction)
NCT02142036
https://clinicaltrials.gov/ct2/show/NCT02142036?term=NCT02142036&rank=1
Sponsor: Oslo University Hospital
Purpose: In the MetAction study, patients will receive therapy based on molecular aberrations in the metastatic lesions, actionable target identification (ATI), rather than on histological tumor type.
Contact: Kjersti Flatmark, MD PhD, +47 22 78 18 63
Kjersti.Flatmark@rr-research.no
Contact: Svein Dueland, MD, + 47 22 93 40 00, svedue@ous-hf.no
CREATE: Cross-tumoral Phase 2 With Crizotinib
NCT01524926
Sponsor: European Organisation for Research and Treatment of Cancer – EORTC
Purpose: The study will primarily assess the antitumor activity of crizotinib in a variety of tumors with alterations in ALK and/or MET pathways. The targeted patient population will include patients with tumors harboring specific alterations leading to ALK and/or MET activation, where tyrosine kinase inhibitors against these targets have not yet been adequately explored.
Efficacy and Safety of the Combination Therapy of Dabrafenib and Trametinib in Subjects With BRAF V600E- Mutated Rare Cancers
NCT02034110
https://clinicaltrials.gov/ct2/show/NCT02034110?term=NCT02034110&rank=1
Sponsor: GlaxoSmithKline
Purpose: This study is designed to determine the overall response rate (ORR) of oral Dabrafenib in combination with oral Trametinib in subjects with rare BRAF V600E mutated cancers.
Contact: US GSK Clinical Trials Call Center, 877-379-3718
GSKClinicalSupportHD@gsk.com
Contact: EU GSK Clinical Trials Call Center, +44 (0) 20 8990 4466
GSKClinicalSupportHD@gsk.com
Study of INC280 in Patients With c-MET Dependent Advanced Solid Tumors
NCT01324479
https://clinicaltrials.gov/ct2/show/NCT01324479?term=NCT01324479&rank=1
Sponsor: Novartis Pharmaceuticals
Purpose: This study will assess the safety and efficacy of INC280 in patients with solid tumors that are refractory to current treatment or for which there is not a current standard of care and whose tumors have dysregulation of the c-MET pathway.
Contact: Novartis Pharmaceuticals, 1-888-669-6682
Palliation
The Palliative Radiotherapy And Inflammation Study – PRAIS
NCT02107664
https://clinicaltrials.gov/ct2/show/NCT02107664?term=NCT02107664&rank=1
Sponsor: Norwegian University of Science and Technology
Purpose: The primary analysis in the study is to identify potential predictors for pain relief from RT. During follow up the study will also explore for predictors for development of cachexia and which inflammatory substances that are associated with changes in pain intensity, depression and development of cachexia.
Contact: Pål Klepstad, prof., +47 72575709, pal.klepstad@ntnu.no
Contact: Ragnhild Habberstad, md + 47 72827705, ragnhild.hansdatter.habberstad@stolav.no
Nasal Fentanyl for Chronic Cancer Pain (NFCP-2)
NCT01906073
https://clinicaltrials.gov/ct2/show/NCT01906073?term=NCT01906073&rank=1
Sponsor: Norwegian University of Science and Technology
Purpose: Because of rapid pain relief, the new fentanyl drugs open for the possibility to take an opioid on demand when pain occurs. The participants will be treated with rapid-acting fentanyl nasal spray and long-acting morphine in a crossover study. The primary outcome will be patient satisfaction.
Contact: Morten Thronæs, MD, morten.thrones@ntnu.no
Contact: Ola Dale, MD prof, ola.dale@ntnu.no
The Orkdal Model. Collaboration Between Specialist and Community Care Within Palliative Cancer Care
NCT02170168
https://clinicaltrials.gov/ct2/show/NCT02170168?term=NCT02170168&rank=1Sponsor: St. Olavs Hospital
Purpose: The overall aim of this project is to deliver better health care services through improved coordination of cancer care within specialist care (at the local hospital Orkdal Hospital) and community care (13 municipalities in the Orkdal region, Norway), and between these two levels in the health care system.
Contact: Anne Kari Knudsen, MD PhD, anne.k.knudsen@ntnu.no
Contact: Anne-Tove Brenne, MD PhD, anne.tove.brenne@stolav.no
Multimodal Intervention for Cachexia in Advanced Cancer Patients Undergoing Chemotherapy (MENAC)
NCT02330926
https://clinicaltrials.gov/ct2/show/NCT02330926?term=NCT02330926&rank=1
Sponsor: Norwegian University of Science and Technology
The overall aim of this study is to early prevent the development of cachexia rather than treatment late in the disease trajectory.
Contact: Trude R Balstad, PhD, trude.r.balstad@ntnu.no
Contact: Tora S Solheim, MD PhD, tora.l.skeidsvoll@ntnu.no