StudyFinder
FOLFOX in Combination With Binimetinib as 2nd Line Therapy for Patients With Advanced Biliary Tract Cancers With MAPK Pathway Alterations: A ComboMATCH Treatment Trial
Status: Recruiting
This ComboMATCH treatment trial compares the usual treatment of modified leucovorin, fluorouracil and oxaliplatin (mFOLFOX6) chemotherapy to using binimetinib plus mFOLFOX6 chemotherapy to shrink tumors in patients with biliary tract cancers that have spread to other places in the body (advanced) and had progression of cancer after previous treatments (2nd line setting).
Sex: Male or Female
Age Group: 18 years and over
Inclusion Criteria:
• must have enrolled onto clinical trial EAY191 and have been given a treatment assignment to ComboMATCH to EAY191-A6 based on the presence of specific mutation as defined in EAY191
• disease has progressed on gemcitabine based first-line regimen
• adequate contraception is required
• walking and able to do all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
• see link to clinicaltrials.gov for complete Inclusion and Exclusion criteria
Exclusion Criteria:
• women who are pregnant or breast feeding
• inability to swallow oral medications or impaired gastrointestinal absorption due to gastrectomy or active inflammatory bowel disease
Interventions:
Drug: Binimetinib, Procedure: Biopsy Procedure, Procedure: Biospecimen Collection, Procedure: Bone Scan, Procedure: Computed Tomography, Procedure: Echocardiography Test, Drug: Fluorouracil, Drug: Leucovorin Calcium, Procedure: Magnetic Resonance Imaging, Procedure: Multigated Acquisition Scan, Drug: Oxaliplatin
Conditions:
Cancer
Keywords:
Biliary Cancer, Gall Bladder cancer
Study Contact: Kristen Nelson - knelso65@fairview.org
Principal Investigator: Peter Friedell
Phase: PHASE2
IRB Number: MMCORC081
See this study on ClinicalTrials.gov