This study is in progress, not accepting new patients

Phase 3 Study of MRTX849 With Cetuximab vs Chemotherapy in Patients With Advanced Colorectal Cancer With KRAS G12C Mutation (KRYSTAL-10)

a study on Colorectal Cancer Colorectal Tumor

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Fresno, California and other locations
Dates
study started
completion around

Description

Summary

Study CA239-0006 is an open-label, randomized Phase 3 clinical trial comparing the efficacy of MRTX849 administered in combination with cetuximab versus chemotherapy in the second-line treatment setting in patients with CRC with KRAS G12C mutation.

Official Title

A Randomized Phase 3 Study of MRTX849 in Combination With Cetuximab Versus Chemotherapy in Patients With Advanced Colorectal Cancer With KRAS G12C Mutation With Disease Progression On or After Standard First-Line Therapy

Keywords

Advanced Colorectal Cancer, Metastatic Colorectal Cancer, Colorectal Cancer, Colorectal Cancer Trial, Colorectal Carcinoma, Rectal Cancer, Colon Cancer, KRAS, KRAS G12C, RAS, Colorectal Adenocarcinoma, Colorectal Neoplasms, Cetuximab, Adagrasib, MRTX849, mFOLFOX6 Regimen, FOLFIRI Regimen, MRTX849 + Cetuximab

Eligibility

You can join if…

Open to people ages 18 years and up

  • Histologically confirmed diagnosis of colorectal carcinoma with KRAS G12C mutation in tumor tissue.
  • Prior receipt of 1st line treatment in advanced CRC with a fluoropyrimidine-based chemotherapy regimen containing either oxaliplatin or irinotecan, and radiographically documented progression of disease on or after treatment.

You CAN'T join if...

  • Prior treatment with a therapy targeting KRAS G12C mutation (e.g., AMG 510).
  • Prior treatment with an anti-EGFR antibody (e.g., cetuximab or panitumumab).
  • Active brain metastasis

Locations

  • UCSF - Fresno Center for Medical Education and Research
    Fresno California 93701 United States
  • California Pacific Medical Center Research Institute
    San Francisco California 94115 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Mirati Therapeutics Inc.
Links
BMS Clinical Trial Information BMS Clinical Trial Patient Recruiting
ID
NCT04793958
Phase
Phase 3 research study
Study Type
Interventional
Participants
About 461 people participating
Last Updated