Solid Tumors
Conditions
Keywords
Adagrasib, KRAS G12C, KRAS, NSCLC, CRC, Krazati
Brief summary
This is an open-label, solid tumor, continuation, rollover trial which enrolls participants from ongoing BMS parent studies that evaluated adagrasib (MRTX849, BMS-986503) either as monotherapy or in combination with other cancer therapies in patients with non-small cell lung cancer (NSCLC), colorectal cancer (CRC) and other advanced solid tumors.
Interventions
DRUGAdagrasib
Specified dose on specified days
DRUGPembrolizumab
Specified dose on specified days
DRUGCetuximab
Specified dose on specified days
DRUGPemetrexed
Specified dose on specified days
DRUGDocetaxel
Specified dose on specified days
DRUGIrinotecan
Specified dose on specified days
DRUGLeucovorin
Specified dose on specified days
DRUGOxaliplatin
Specified dose on specified days
DRUGFluorouracil
Specified dose on specified days
Sponsors
Mirati Therapeutics Inc.
Study design
Allocation
NA
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participant is eligible to receive continued study treatment as per the parent study, and/or investigator assessed clinical benefit. * Individuals with assigned female sex at birth (AFSB) must have documented proof that they are not of childbearing potential. IOCBP participants who are sexually active must agree to follow the instructions for method(s) of contraception and included in the ICF.
Exclusion criteria
* Participant is not eligible for study treatment per the parent study eligibility criteria. * Participants who have completed treatment with the study drugs, progressed on prior study treatment, or discontinued study treatment due to toxicity in the parent study are not eligible to receive study drug in this study. * Participants not receiving clinical benefit from parent study drug as assessed by the investigator. Other protocol defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants With Adverse Events (AEs) | Up to 90 days from last dose or study discontinuation |
| Number of Participants With AEs Leading to Treatment Discontinuation | Up to 90 days from last dose or study discontinuation |
| Number of Participants With Serious Adverse Events (SAEs) | Up to 90 days from last dose or study discontinuation |
| Number of Participants With AEs Leading to Death | Up to 90 days from last dose or study discontinuation |
Countries
Australia, Belgium, Canada, China, France, Germany, Greece, Hungary, Israel, Italy, Japan, Netherlands, Poland, Portugal, Romania, Singapore, South Korea, Spain, United Kingdom, United States
Contacts
CONTACTBMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACTFirst line of the email MUST contain NCT # and Site #.
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed