Neoplasms

Digestive System Diseases

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Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

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Capecitabine

Antimetabolites

A phase lb/ll, open label, single arm study with Alpelisib plus Capecitabine in patients with PIK3CA mutant metastatic colorectal cancer

Adding Alpelisib to Capecitabine as a salvage regimen in mCRC with PIK3CA mutation

Alpelisib plus Capecitabine combination

Soohyeon Lee, MD

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.

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)

A phase lb/ll, open label, single arm study

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

Maxiaml Tolerable Dose and Recommended Phase 2 Dose of combination Maximal tolerable dose and random phase 2 dose confirmation in Alpelisib with Capecitabine in phase 1b

Spots Global Cancer Trial Database for alpelisib plus capecitabine combination