Spots Global Cancer Trial Database for Alpelisib and Capecitabine in Patients With PIK3CA Mutant mCRC Patients
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Trial Identification
Brief Title: Alpelisib and Capecitabine in Patients With PIK3CA Mutant mCRC Patients
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
Study ID: NCT04753203
Interventions
Study Description
Brief 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)
Keywords
Eligibility
Minimum Age: 19 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Korea University Anam Hospital, Seoul, , Korea, Republic of
Contact Details
Name: Soohyeon Lee, MD
Affiliation: Korea Cancer Study Group
Role: PRINCIPAL_INVESTIGATOR
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