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Adagrasib in Combination With Palbociclib in Patients With Advanced Solid Tumors (KRYSTAL-16)

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ClinicalTrials.gov Identifier: NCT05178888
Recruitment Status : Recruiting
First Posted : January 5, 2022
Last Update Posted : February 22, 2022
Sponsor:
Information provided by (Responsible Party):
Mirati Therapeutics Inc.

Brief Summary:
This study will evaluate the safety and clinical activity of MRTX849 (adagrasib) in combination with palbociclib in patients with advanced solid tumor malignancies with KRAS G12C mutation.

Condition or disease Intervention/treatment Phase
Advanced Solid Tumor Drug: MRTX849 Drug: Palbociclib Phase 1

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

Detailed Description:
This study will evaluate the pharmacokinetics and preliminary clinical activity of MRTX849 (adagrasib) in combination with palbociclib in patients with advanced solid tumor malignancies with KRAS G12C mutation. MRTX849 is an orally available small molecule inhibitor of KRAS G12C and palbociclib is a small molecule inhibitor of CDK 4 and 6.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/1b Trial of MRTX849 in Combination With Palbociclib in Patients With Advanced Solid Tumors With KRAS G12C Mutation
Actual Study Start Date : February 1, 2022
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : March 30, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Palbociclib

Arm Intervention/treatment
Experimental: Dose Escalation
Dose escalation of MRTX849 and palbociclib to determine maximum tolerated dose in combination.
Drug: MRTX849
KRAS G12C inhibitor
Other Names:
  • KRAS G12C
  • adagrasib

Drug: Palbociclib
CDK 4 and 6 inhibitor
Other Name: IBRANCE

Experimental: 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.
Drug: MRTX849
KRAS G12C inhibitor
Other Names:
  • KRAS G12C
  • adagrasib

Drug: Palbociclib
CDK 4 and 6 inhibitor
Other Name: IBRANCE




Primary Outcome Measures :
  1. Characterize the number of patients with treatment emergent adverse events of the combination regimen in patients with advanced solid tumor malignancies with KRAS G12C mutation. [ Time Frame: 24 months ]
    Number of participants with treatment emergent adverse events

  2. Evaluate Pharmacokinetics of the combination regimen [ Time Frame: 24 months ]
    Plasma concentration

  3. Establish Maximum Tolerated Dose [ Time Frame: 24 months ]
    Number of patients with dose limiting toxicity

  4. Evaluate preliminary clinical activity of the combination regimen [ Time Frame: 24 months ]
    Objective response rate in accordance with Response Evaluation Criteria in Solid Tumors (RECIST)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed diagnosis of a solid tumor malignancy with KRAS G12C mutation
  • Unresectable or metastatic disease.
  • No available treatment with curative intent
  • Adequate organ function

Exclusion Criteria:

  • History of significant toxicity on prior KRAS G12C or CDK4/6 inhibitor therapies
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05178888


Contacts
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Contact: Mirati Therapeutics Study Locator Services 1-844-893-5530 miratistudylocator@emergingmed.com
Contact: Xenophon Ianopulos, MD, PhD

Locations
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United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Next Oncology Recruiting
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Mirati Therapeutics Inc.
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Responsible Party: Mirati Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT05178888    
Other Study ID Numbers: 849-016
First Posted: January 5, 2022    Key Record Dates
Last Update Posted: February 22, 2022
Last Verified: February 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms
Palbociclib
Adagrasib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action