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Trial record 3 of 3 for:    KRAS G12C

A Phase 1/2, Study Evaluating the Safety, Tolerability, PK, and Efficacy of AMG 510 in Subjects With Solid Tumors With a Specific KRAS Mutation.

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. Identifier: NCT03600883
Recruitment Status : Recruiting
First Posted : July 26, 2018
Last Update Posted : September 20, 2019
Information provided by (Responsible Party):

Brief Summary:

Evaluate the safety and tolerability of AMG 510 in adult subjects with KRAS p.G12C mutant advanced solid tumors.

Estimate the maximum tolerated dose (MTD) and/or a recommended phase 2 dose (RP2D) in adult subjects with KRAS p.G12C mutant advanced solid tumors.

Condition or disease Intervention/treatment Phase
KRAS p.G12C Mutant Advanced Solid Tumors Drug: AMG 510 Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 158 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2, Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of AMG 510 Monotherapy in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation and AMG 510 Combination Therapy in Subjects With Advanced NSCLC With KRAS p.G12C
Actual Study Start Date : August 27, 2018
Estimated Primary Completion Date : December 27, 2022
Estimated Study Completion Date : December 29, 2023

Arm Intervention/treatment
Experimental: Dose Exploration Part 1 monotherapy
Enrollment into the dose exploration cohorts may be from any eligible solid tumor type. Dose escalation will begin with 2-4 subjects treated at the lowest planned dose level of 180 mg. If no DLT is observed, dose escalation will continue to the next planned dose cohort
Drug: AMG 510
Characterize the pharmacokinetics (PK) of AMG 510 following administration as an oral Tablet formulation

Experimental: Dose Expansion Part 2 monotherapy
Upon completing the dose exploration part of the study and depending on data obtained, dose expansion may proceed with 2 groups consisting of subjects with KRAS p.G12C mutant advanced solid tumors Dose expansion in these 2 groups may be done concurrently.
Drug: AMG 510
Characterize the pharmacokinetics (PK) of AMG 510 following administration as an oral Tablet formulation

Experimental: Phase 2 monotherapy
Additional subjects will be enrolled in the dose expansion to confirm the recommended phase 2 dose. Enrollment into phase 2 will be opened after confirmation of the recommended phase 2 dose
Drug: AMG 510
Characterize the pharmacokinetics (PK) of AMG 510 following administration as an oral Tablet formulation

Experimental: Combination arm with AMG 510 and anti PD-1/L1
Additional subjects will be enrolled into the combination arm with AMG 510 in combination with an anti (PD-1/L1)
Drug: AMG 510
Characterize the pharmacokinetics (PK) of AMG 510 following administration as an oral Tablet formulation

Primary Outcome Measures :
  1. Number of Participants With Abnormal Laboratory Values [ Time Frame: 24 Months ]
  2. Number of subjects with clinically significant changes in vital signs. [ Time Frame: 24 Months ]
  3. Number of subjects with changes on ECG. [ Time Frame: 24 Months ]

Secondary Outcome Measures :
  1. Plasma concentration (Cmax) [ Time Frame: 24 Months ]
  2. Time to achieve Cmax (tmax) [ Time Frame: 24 Months ]
  3. Area under the plasma concentration-time curve (AUC) [ Time Frame: 24 Months ]
  4. Objective response rate [ Time Frame: 24 months ]
  5. Duration of overall response [ Time Frame: 24 Months ]
  6. Progression-free survival [ Time Frame: 24 Months ]
  7. Duration of stable disease [ Time Frame: 24 Months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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

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 DNA sequencing.

Exclusion Criteria

  • 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 identifier (NCT number): NCT03600883

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Contact: Amgen Call Center 866-572-6436

  Hide Study Locations
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United States, California
Research Site Recruiting
Duarte, California, United States, 91010
Research Site Recruiting
San Francisco, California, United States, 94115
Research Site Recruiting
Santa Monica, California, United States, 90403
United States, Colorado
Research Site Recruiting
Denver, Colorado, United States, 80218
United States, Indiana
Research Site Recruiting
Indianapolis, Indiana, United States, 46202
United States, Massachusetts
Research Site Recruiting
Boston, Massachusetts, United States, 02114
United States, Michigan
Research Site Recruiting
Ann Arbor, Michigan, United States, 48109
United States, Missouri
Research Site Recruiting
Saint Louis, Missouri, United States, 63110-1093
United States, New York
Research Site Recruiting
Buffalo, New York, United States, 14263
Research Site Recruiting
New York, New York, United States, 10065
United States, North Carolina
Research Site Recruiting
Durham, North Carolina, United States, 27710
United States, Pennsylvania
Research Site Recruiting
Philadelphia, Pennsylvania, United States, 19111
Research Site Recruiting
Pittsburgh, Pennsylvania, United States, 15232
United States, South Carolina
Research Site Recruiting
Spartanburg, South Carolina, United States, 29303
United States, Texas
Research Site Recruiting
Houston, Texas, United States, 77030
United States, Utah
Research Site Recruiting
Salt Lake City, Utah, United States, 84112
United States, Washington
Research Site Recruiting
Seattle, Washington, United States, 98109
Australia, New South Wales
Research Site Recruiting
Randwick, New South Wales, Australia, 2031
Australia, South Australia
Research Site Recruiting
Woodville South, South Australia, Australia, 5011
Australia, Victoria
Research Site Recruiting
Melbourne, Victoria, Australia, 3000
Research Site Recruiting
Marseille cedex 5, France, 13385
Research Site Recruiting
Villejuif, France, 94805
Research Site Recruiting
Kashiwa-shi, Chiba, Japan, 277-8577
Research Site Recruiting
Fukuoka-shi, Fukuoka, Japan, 811-1395
Korea, Republic of
Research Site Recruiting
Seoul, Korea, Republic of, 03080
Research Site Recruiting
Seoul, Korea, Republic of, 05505
Research Site Recruiting
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
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Study Director: MD Amgen

Additional Information:
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Responsible Party: Amgen Identifier: NCT03600883     History of Changes
Other Study ID Numbers: 20170543
First Posted: July 26, 2018    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019
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 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. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. 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 link below.

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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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