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Alpelisib and Capecitabine in Patients With PIK3CA Mutant mCRC Patients

NCT04753203 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2023-10-31

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Alpelisib plus Capecitabine combination

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

Sponsors & Collaborators

  • Korean Cancer Study Group

    lead OTHER

Principal Investigators

  • Soohyeon Lee, MD · Korea Cancer Study Group

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-28
Primary Completion
2024-02-28
Completion
2025-02-28
FDA Drug
Yes

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04753203 on ClinicalTrials.gov