Ignite Creation Date:
2024-05-06 @ 3:47 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04753203
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-10-31
First Post:
2021-02-04
Brief Title:
Alpelisib and Capecitabine in Patients With PIK3CA Mutant mCRC Patients
Sponsor:
Korean Cancer Study Group
Organization:
Korean Cancer Study Group
Study Overview
Official Title:
A Phase lbll 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:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ALCAP
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None