At a glance
ClinicalIndex Comparison Record- ✓Advanced solid tumors with no remaining treatment options (Phase I) OR colorectal cancer progressed on at least one line of fluoropyrimidine-containing therapy
- ✓For colorectal cancer: prior oxaliplatin or irinotecan combined with fluoropyrimidine in front-line setting required, unless contraindicated
- ✓Phase II only: PIK3CA mutant metastatic colorectal cancer confirmed by CLIA-certified tumor sequencing
- ✓ECOG performance status 0–1
- ✕Untreated brain metastases or CNS disease
- ✕Ongoing toxicity >grade 1 (excluding alopecia) from prior anti-cancer therapy
- ✕Recent prior therapy: radiation within 2 weeks, chemotherapy or investigational therapy within 4 weeks
- ✕Allergic reaction or intolerance to CB-839 or capecitabine; if prior capecitabine, must have tolerated at least equivalent dose
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase I/II Study of CB-839 and Capecitabine in Patients With Advanced Solid Tumors and Fluoropyrimidine Resistant PIK3CA Mutant Colorectal Cancer
In Brief
A Phase 2 clinical trial evaluating CB-839 and Capecitabine for Colorectal Cancer and 3 related conditions. Completed, enrolled 50 participants across 2 sites.
Detailed Summary
This study has two portions. The main goal of the Phase I portion of this research study is to see what doses of CB-839 and capecitabine can safely be given to patients without having too many side effects. Other purposes of this research study will be to determine what side effects are seen with this combination of medicines. The Phase II portion of the study will test how many patients show shrinkage in their tumor with this combination of medicines and what changes occur inside the cancer cells and blood cells after treatment.
Study Details
Timeline
Interventions
Patients will receive CB-839 orally twice daily during each cycle. Each cycle will be 21 days long. Disease assessment will occur after cycle 3.
capecitabine will be given orally twice daily for 14-21 days of cycles. Each cycle will be 21 days long. Disease assessment will occur after cycle 3.