A Study of Select Drug Combinations in Adult Patients With Advanced/Metastatic BRAF V600 Colorectal Cancer
A Phase Ib, Multicenter, Open-label Dose Escalation and Expansion Platform Study of Select Drug Combinations in Adult Patients With Advanced or Metastatic BRAF V600 Colorectal Cancer
ClinicalTrials.gov Identifier: NCT04294160
Novartis Reference Number: CADPT01C12101
Last Update: Apr 14, 2022
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.
Study Description
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 for future studies.
Interventions
Eligibility Criteria
Key Inclusion Criteria:
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 Criteria:
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.
Study Locations
Contacts
Have a question?
Call 1-888-669-6682 or email [email protected]