Status:
TERMINATED
A Study of Select Drug Combinations in Adult Patients With Advanced/Metastatic BRAF V600 Colorectal Cancer
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
BRAF V600 Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
A phase Ib, open-label platform study of select drug combinations chosen in order to characterize safety and tolerability of each treatment arm tested and to identify recommended doses and regimens fo...
Detailed Description
This is a phase Ib, multi-center, open-label study with multiple treatment arms in adult patients with advanced or metastatic BRAF V600 (E, D, or K) in order to characterize safety and tolerability of...
Eligibility Criteria
Inclusion
- Key
- Patients must have a site of disease amenable to biopsy, and be a candidate for tumor biopsy according to the treating institution's guidelines. Patients must be willing to undergo a new tumor biopsy at baseline and during on study therapy. Exceptions may be considered after documented discussion with Novartis.
- All patients must have a BRAF V600 mutation confirmed by local assessment.
- Patients with unresectable advanced/metastatic BRAF V600 cancer of the colon or rectum with measurable disease as determined by RECIST v1.1
- Patients must have documented disease progression following, or are intolerant to, 1 or 2 lines of chemotherapy for advanced/metastatic disease
- Key
Exclusion
- Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy, or in-situ cervical cancer, or other tumors that will not affect life expectancy
- Impairment of gastrointestinal function or gastrointestinal disease that may signficantly alter the absorption of study drugs
- History of or current evidence/risk of retinal verin occlusion or serous retinopathy
- History of or current interstitial lung disease or non-infectious pneumonitis
- Patients with a known history of testing positive for HIV
- Clinically significant cardiac disease at screening
- Any medical condition that would, in the investigator's judgment, prevent the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures.
- Pregnant or lactating women
- Other protocol-defined inclusion/exclusion may apply.
Key Trial Info
Start Date :
July 22 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 25 2024
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT04294160
Start Date
July 22 2020
End Date
September 25 2024
Last Update
December 24 2025
Active Locations (18)
Enter a location and click search to find clinical trials sorted by distance.
1
University of California LA Santa Monica Location
Los Angeles, California, United States, 90095
2
Massachusetts General Hospital Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
3
Sarah Cannon Research Institute SC
Nashville, Tennessee, United States, 37203
4
Uni Of TX MD Anderson Cancer Cntr
Houston, Texas, United States, 77030