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
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ABSTRACT: Interventions: Drug : Alpelisib: oral administration
In Phase lb, 200mg and 300mg once daily will be tested.
In Phase ll, the recommended phase ll dose (RP2D) in phase lb will be used.
Capecitabine: oral administration,
In Phase lb, 850mg, 1000mg, 1250mg twice daily will be tested.
In Phase ll, the recommended phase ll dose (RP2D) in phase lb twice daily on day 1 to 14 followed by 7 days off
Primary outcome(s): PFS, Progression Free Survival
DISEASE(S): Neoplasms
PROVIDER: 2513615 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
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