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Kinase Inhibitor
Chemotherapy + Binimetinib for Biliary Tract Cancer
Phase 2
Recruiting
Led By Ardaman Shergill
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
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.
Who is the study for?
Adults with advanced biliary tract cancers that have worsened after first-line treatment can join. They must not be pregnant, agree to use contraception, and have no history of certain eye diseases or severe allergies to trial drugs. Participants need a specific mutation in their cancer but cannot have BRAF V600E mutations or high blood pressure uncontrolled by medication.
What is being tested?
The study compares standard chemotherapy (mFOLFOX6) alone versus mFOLFOX6 combined with Binimetinib, a kinase inhibitor that may help stop cancer cells from multiplying. The goal is to see if adding Binimetinib improves outcomes for patients who've already had one round of treatment.
What are the potential side effects?
Possible side effects include allergic reactions, fatigue, digestive issues like bowel perforation or fistulas, skin disorders requiring systemic therapy within the past year, and increased risk of infections due to low blood counts.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Overall survival (OS)
Secondary study objectives
Clinical benefit
Duration of response (DoR)
Incidence of adverse events
+2 moreOther study objectives
Activity of addition of binimetinib therapy to standard 2nd line chemotherapy
Albumin
Changes in plasma MAPK mutations allelic burden and other molecular findings
+4 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm 2 (binimetinib, mFOLFOX6)Experimental Treatment11 Interventions
Patients receive binimetinib PO on days 1-14, and leucovorin IV, oxaliplatin IV, and fluorouracil IV as in Arm 1. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity. Patients undergo ECHO or MUGA and collection of blood during screening and on study, and undergo CT with contrast, MRI, or FDG-PET throughout the trial as clinically indicated. Patients may also undergo bone scans on study and may undergo biopsies throughout the study as clinically indicated.
Group II: Arm 1 (mFOLFOX6)Active Control10 Interventions
Patients receive leucovorin IV over 2 hours and oxaliplatin IV over 2 hours on day 1, and fluorouracil IV over 46-48 hours on days 1-2. Cycles repeat every 14 days in the absence of disease progression or unacceptable toxicity. Patients undergo collection of blood during screening and on study, and undergo CT with contrast, MRI, or FDG-PET throughout the trial as clinically indicated. Patients may also undergo bone scans on study and may undergo biopsies throughout the study as clinically indicated.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 3
~2020
Bone Scan
2015
Completed Phase 2
~50
Fluorouracil
2014
Completed Phase 3
~11700
Multigated Acquisition Scan
2015
Completed Phase 3
~270
Oxaliplatin
2011
Completed Phase 4
~2890
Computed Tomography
2017
Completed Phase 2
~2740
Echocardiography
2013
Completed Phase 4
~11580
Leucovorin Calcium
2011
Completed Phase 3
~12500
Magnetic Resonance Imaging
2017
Completed Phase 3
~1160
Binimetinib
2018
Completed Phase 3
~1250
Biopsy
2014
Completed Phase 4
~1090
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,928 Previous Clinical Trials
41,017,972 Total Patients Enrolled
104 Trials studying Cholangiocarcinoma
10,767 Patients Enrolled for Cholangiocarcinoma
Ardaman ShergillPrincipal InvestigatorAlliance for Clinical Trials in Oncology
1 Previous Clinical Trials
21 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1 (mFOLFOX6)
- Group 2: Arm 2 (binimetinib, mFOLFOX6)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.
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