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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

Tracking Information
First Submitted Date  ICMJE December 3, 2019
First Posted Date  ICMJE December 4, 2019
Last Update Posted Date January 21, 2020
Actual Study Start Date  ICMJE December 17, 2019
Estimated Primary Completion Date July 7, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 3, 2019)
  • Number of Participants with Abnormal Laboratory Values [ Time Frame: 12 months ]
  • Number of subjects with clinically significant changes in vital signs. [ Time Frame: 12 months ]
  • Number of subjects with changes on ECG. [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 3, 2019)
  • Maximum Plasma concentration (Cmax) [ Time Frame: 12 months ]
  • Time to maximum plasma concentration (tmax) [ Time Frame: 12 months ]
  • Area under the plasma concentration-time curve (AUC) [ Time Frame: 12 months ]
  • Disease control rate [ Time Frame: 12 months ]
  • Duration of response [ Time Frame: 12 Months ]
  • Progression-free survival [ Time Frame: 12 months ]
  • Duration of stable disease [ Time Frame: 12 Months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE AMG 510 Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)
Official Title  ICMJE 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)
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Advanced Solid Tumors
  • Kirsten Rat Sarcoma (KRAS) pG12C Mutation
Intervention  ICMJE
  • Drug: AMG 510
    AMG 510+ MEKi
  • Drug: PD1 inhibitor
    AMG 510 + PD1i
Study Arms  ICMJE
  • 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.
    Intervention: Drug: AMG 510
  • 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.
    Intervention: Drug: PD1 inhibitor
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 3, 2019)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2, 2024
Estimated Primary Completion Date July 7, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Amgen Call Center 866-572-6436 medinfo@amgen.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04185883
Other Study ID Numbers  ICMJE 20190135
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Informed Consent Form (ICF)
Supporting Materials: 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
Responsible Party Amgen
Study Sponsor  ICMJE Amgen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: MD Amgen
PRS Account Amgen
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP