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Chemotherapy + Binimetinib for Biliary Tract Cancer
Study Summary
This trial tests a combo of meds to treat advanced biliary tract cancer that worsened after previous treatments. Drugs may slow/stop growth & kill tumor cells.
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Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- My blood pressure is controlled and below 160/90.I can swallow pills and do not have issues absorbing them due to stomach surgery or bowel inflammation.My cancer does not have the BRAF V600E mutation.My kidneys work well enough, with a creatinine clearance rate of at least 50 mL/min.My cancer has specific genetic changes known as RAS/RAF/MEK/ERK mutations.I have not had minor surgery in the last 2 weeks.I have never been treated with drugs specifically targeting KRAS.I haven't had any bowel perforation or intestinal fistulas in the past 6 months.I am 18 years old or older.I haven't had major surgery in the last 4 weeks, except for getting a vascular access.I have never had rhabdomyolysis.I can safely undergo a biopsy and agree to it, or I have tissue samples from the last year.I have never been treated with MEK inhibitors.I haven't had palliative radiotherapy in the last week.My white blood cell count is healthy without recent growth factor treatment.I can take care of myself but might not be able to do heavy physical work.I haven't needed treatment for a skin condition in the last year.My hemoglobin level is at least 8 g/dL and I haven't had a blood transfusion in the last 14 days.I have never had lung diseases like fibrosis or pneumonia.My heart is healthy, with no recent severe heart issues or specific heart rhythm problems.My cancer can be measured and was checked within the last 28 days.I haven't had any cancer treatments in the last 4 weeks.My bile duct or gallbladder cancer cannot be surgically removed and has a specific genetic mutation, but not BRAFV600E.I am not pregnant or nursing and willing to use contraception during and after the treatment.My cancer progressed after first-line treatment with gemcitabine.I've had chemo with 5-FU or capecitabine and failed first-line chemo after my cancer came back.I don't have serious eye problems, untreated HIV, hepatitis, or a history of severe allergies to the study drugs.
- Group 1: Arm 2 (binimetinib, mFOLFOX6)
- Group 2: Arm 1 (mFOLFOX6)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are there still openings to join this experimental treatment protocol?
"Affirmative. Information on clinicaltrials.gov states that this medical trial opened its doors for recruitment on May 7th 2024, and was recently updated on August 26th 2023. The study is currently seeking 66 individuals across 19 different sites."
What is the current allotment of participants for this experimental research?
"Affirmative, clinicaltrials.gov reports that this medical experimentation is actively recruiting patient volunteers. Originally posted on May 7th 2024 and modified August 26th 2023, 66 participants are being enrolled at 19 different sites."
Are there a plethora of medical centers enacting this clinical experiment across the US?
"This medical study has 19 potential sites for recruitment. These include Decatur Memorial Hospital in Effingham, Crossroads Cancer Centre in Springfield and Southern Illinois University School of Medicine located in Ann Arbor alongside 16 other possible locations."
Has the FDA sanctioned binimetinib and mFOLFOX6 in Arm 2?
"Based on the existing evidence, our group at Power rated Arm 2 (binimetinib & mFOLFOX6) a 2 for safety. This is due to it being in Phase 2 of clinical trials and having some empirical data supporting its security, but none proving efficacy."
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