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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.

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ClinicalTrials.gov Identifier: NCT03600883
Recruitment Status : Recruiting
First Posted : July 26, 2018
Last Update Posted : October 10, 2019
Sponsor:
Information provided by (Responsible Party):
Amgen

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 29, 2022
Estimated Study Completion Date : March 31, 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

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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 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 ClinicalTrials.gov identifier (NCT number): NCT03600883


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

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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: NCT03600883     History of Changes
Other Study ID Numbers: 20170543
First Posted: July 26, 2018    Key Record Dates
Last Update Posted: October 10, 2019
Last Verified: October 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.
URL: https://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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Neoplasms