Phase 1/2 Study of MRTX849 in Patients With Cancer Having a KRAS G12C Mutation KRYSTAL-1
This study will evaluate the safety, tolerability, drug levels, molecular effects, and clinical activity of MRTX849 (adagrasib) in patients with advanced solid tumors that have a KRAS G12C mutation.
Midazolam DDI substudy will examine effect of of repotrectinib on CYP3A induction.
Phase 2 will determine the confirmed Overall Response Rate (ORR) as assessed by Blinded Independent Central Review (BICR) of repotrectinib in each subject population expansion cohort of advanced solid tumors that harbor a ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement. The secondary objective will include the duration of response (DOR), time to response (TTR), progression-free survival (PFS), overall survival (OS) and clinical benefit rate (CBR) of repotrectinib in each expansion cohort of advanced solid tumors that harbor a ROS1, NTRK1, NTRK2, or NTRK3 gene rearrangement.
Study Type : Interventional (Clinical Trial)- Estimated Enrollment : 822 participants
- Allocation : Non-Randomized
- Intervention Model : Sequential Assignment
- Masking : None (Open Label)
- Primary Purpose : Treatment
- Official Title : A Phase 1/2 Multiple Expansion Cohort Trial of MRTX849 in Patients With Advanced Solid Tumors With KRAS G12C Mutation KRYSTAL-1
- Actual Study Start Date : January 15, 2019
- Estimated Primary Completion Date : December 2023
- Estimated Study Completion Date : September 2024
ClinicalTrials.gov Identifier:NCT03785249
Sponsor:Mirati Therapeutics Inc.
Information provided by (Responsible Party): Mirati Therapeutics Inc.
View this trial on clinicaltrials.gov.
What is a Clinical Trial?
A clinical trial is required by the FDA for any new therapy to come to market. It involves recruiting volunteers to help prove the therapy actually works. Every pill that you take or procedure that is performed by physicians has went through a clinical trial