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Closed (no longer recruiting)Last updated: 24 May 2024

KRYSTAL-10: This phase III study is evaluating whether a combination of targeted therapies (MRTX849 and Cetuximab) is more effective than chemotherapy (mFOLFOX6 or FOLFIRI regimens) in people with advanced or metastatic colorectal cancer with KRAS G12c mutations who have had previous treatmentA 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

Clinical summary

Summary

Eligible participants will be randomly allocated into either the Experimental Arm or Active Comparator Arm. In the Experimental Arm, participants will receive MRTX849 in combination with Cetuximab. In the Active Comparator Arm, participants will receive either mFOLFOX6 or FOLFIRI regimens of chemotherapy.

Conditions

This trial is treating patients with colorectal cancer that has KRAS G12C mutations

Cancer

Bowel Cancers Lower gastrointestinal tract

Age

People18+

Phase

III

Trial Acronym

KRYSTAL-10

More information

Trial Identifiers

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Trial sponsor

Mirati Therapeutics Inc.

Scientific 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

Eligibility

Inclusion

  • 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.

Exclusion

  • 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

Inclusion

  • Your cancer has spread to other parts of the body.
  • Your cancer has not spread to other parts of the body.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

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