Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 7:34 PM
Ignite Modification Date:
2025-12-24 @ 7:34 PM
NCT ID:
NCT04753203
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)
Study:
NCT04753203
Study Brief:
Protocol Section:
NCT04753203