Alpelisib and Capecitabine in Patients With PIK3CA Mutant mCRC Patients
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Metastatic Colorectal Cancer
- PIK3CA Gene Mutation
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: A phase lb/ll, open label, single arm studyMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 19 years and 90 years
- Gender
- Both males and females
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 ...
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)
Tracking Information
- NCT #
- NCT04753203
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Soohyeon Lee, MD Korea Cancer Study Group
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