Adagrasib in Combination With Palbociclib in Patients With Advanced Solid Tumors (KRYSTAL-16)
NCT ID: NCT05178888
Last Updated: 2025-02-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
11 participants
INTERVENTIONAL
2022-01-20
2024-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Dose Escalation
Dose escalation of MRTX849 and palbociclib to determine maximum tolerated dose in combination.
MRTX849
KRAS G12C inhibitor
Palbociclib
CDK 4 and 6 inhibitor
Dose Expansion
Expansion cohorts may be implemented to ensure sufficient safety experience, pharmacokinetic data and early evidence of clinical activity of MRTX in combination with palbociclib.
MRTX849
KRAS G12C inhibitor
Palbociclib
CDK 4 and 6 inhibitor
Interventions
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MRTX849
KRAS G12C inhibitor
Palbociclib
CDK 4 and 6 inhibitor
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Unresectable or metastatic disease.
* No available treatment with curative intent
* Adequate organ function
Exclusion Criteria
* History of intestinal disease, inflammatory bowel disease, major gastric surgery, or other gastrointestinal conditions likely to alter the absorption of study treatment or result in an inability to swallow
* Other active cancer
* Cardiac abnormalities
18 Years
ALL
No
Sponsors
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Mirati Therapeutics Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution - 804
Orlando, Florida, United States
Local Institution - 803
Nashville, Tennessee, United States
Local Institution - 802
Houston, Texas, United States
Local Institution - 801
San Antonio, Texas, United States
Countries
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Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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CA239-0018
Identifier Type: OTHER
Identifier Source: secondary_id
849-016
Identifier Type: OTHER
Identifier Source: secondary_id
CA239-0018
Identifier Type: -
Identifier Source: org_study_id
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