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AMG 510 Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04185883
Recruitment Status : Recruiting
First Posted : December 4, 2019
Last Update Posted : January 21, 2020
Sponsor:
Information provided by (Responsible Party):
Amgen

Brief Summary:
To evaluate the safety and tolerability of AMG 510 administered in investigational regimens in adult subjects with KRAS p.G12C mutant advanced solid tumors

Condition or disease Intervention/treatment Phase
Advanced Solid Tumors Kirsten Rat Sarcoma (KRAS) pG12C Mutation Drug: AMG 510 Drug: PD1 inhibitor Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1b, Protocol Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of AMG 510 Monotherapy and in Combination With Other Anti-cancer Therapies in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)
Actual Study Start Date : December 17, 2019
Estimated Primary Completion Date : July 7, 2022
Estimated Study Completion Date : December 2, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: AMG 510+ MEKi

Experimental: AMG510 + MEK inhibitor Dose Exploration and Dose Expansion

  • Enrollment into the dose exploration cohort is for eligible subjects with KRAS P.G12C mutant advanced solid tumors.
  • Upon completing the dose exploration part of the study, dose expansion may proceed consisting of subjects with KRAS p.G12C mutant advanced solid tumors.
Drug: AMG 510
AMG 510+ MEKi

Experimental: AMG510+ PD1 inhibitor

Experimental: AMG510 + PD-1inhibitor Dose Exploration and Dose Expansion

  • Enrollment into the dose exploration cohort is for eligible subjects with KRAS P.G12C mutant advanced solid tumors.
  • Upon completing the dose exploration part of the study, dose expansion may proceed consisting of subjects with KRAS p.G12C mutant advanced solid tumors.
Drug: PD1 inhibitor
AMG 510 + PD1i




Primary Outcome Measures :
  1. Number of Participants with Abnormal Laboratory Values [ Time Frame: 12 months ]
  2. Number of subjects with clinically significant changes in vital signs. [ Time Frame: 12 months ]
  3. Number of subjects with changes on ECG. [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Maximum Plasma concentration (Cmax) [ Time Frame: 12 months ]
  2. Time to maximum plasma concentration (tmax) [ Time Frame: 12 months ]
  3. Area under the plasma concentration-time curve (AUC) [ Time Frame: 12 months ]
  4. Disease control rate [ Time Frame: 12 months ]
  5. Duration of response [ Time Frame: 12 Months ]
  6. Progression-free survival [ Time Frame: 12 months ]
  7. Duration of stable disease [ Time Frame: 12 Months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men or women greater than or equal to 18 years old.
  • Pathologically documented, locally-advanced or metastatic malignancy with, KRAS p.G12Cmutation identified through molecular testing.

Exclusion Criteria:

  • Primary brain tumor.
  • Active brain metastases from non-brain tumors.
  • Myocardial infarction within 6 months of study day 1.
  • Gastrointestinal (GI) tract disease causing the inability to take oral medication.

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): NCT04185883


Contacts
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Contact: Amgen Call Center 866-572-6436 medinfo@amgen.com

Locations
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United States, California
City of Hope Active, not recruiting
Duarte, California, United States, 91010
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
Amgen
Investigators
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Study Director: MD Amgen

Additional Information:
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Responsible Party: Amgen
ClinicalTrials.gov Identifier: NCT04185883    
Other Study ID Numbers: 20190135
First Posted: December 4, 2019    Key Record Dates
Last Update Posted: January 21, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication (or other new use) have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors, and if not approved, may be further arbitrated by a Data Sharing Independent Review Panel. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.
URL: http://www.amgen.com/datasharing

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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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Sarcoma
Neoplasms
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type