NCT04753203

Alpelisib and Capecitabine in Patients With PIK3CA Mutant mCRC Patients

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 65 (estimated)
• Sponsor: Korean Cancer Study Group · Academic / Other
• Sex: All
• Age: 19 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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)

Conditions

• Metastatic Colorectal Cancer
• PIK3CA Gene Mutation

Interventions

Type	Name	Description
DRUG	Alpelisib plus Capecitabine combination	Adding Alpelisib to Capecitabine as a salvage regimen in mCRC with PIK3CA mutation

Timeline

• Start date: 2021-02-28
• Primary completion: 2024-02-28
• Completion: 2025-02-28
• First posted: 2021-02-15
• Last updated: 2023-10-31

Locations

1 site across 1 country: South Korea

Regulatory

• FDA-regulated drug study