Metastatic Colorectal Cancer Clinical Trial
Official title:
A Phase lb/ll, Open Label, Single Arm Study to Assess Efficacy and Safety of Alpelisib and Capecitabine in Patients With PIK3CA Mutant Metastatic Colorectal Cancer Who Failed Two Prior Standard Chemotherapies
The investigator assesses the efficacy and safety of alpelisib and capecitabine in patients with PIK3CA mutant metastatic colorectal cancer who failed two prior standard chemotherapies.
Phase lb To determine maximal tolerated dose (MTD) and recommended phase ll dose (RP2D) of alpelisib in combination with capecitabine regardless of PIK3CA mutation of any solid tumors Phase ll To investigate the progression-free survival (PFS) Conduct the exploratory biomarker analysis for efficacy and resistance of alpelisib plus capecitabine combination (using collected clinical samples) ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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Phase 1/Phase 2 | |
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Phase 4 | |
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Phase 2 | |
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Phase 3 | |
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Phase 2 |