Protocol #: 18-626
Status
Recruiting
Description
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
KRAS p.G12C Mutant Advanced Solid Tumors
Interventions
AMG 510
Phase
Phase 1/Phase 2
Study Type
Interventional
Further Study Details
Primary Outcome:
Number of Participants With Abnormal Laboratory Values
Number of subjects with clinically significant changes in vital signs.
Number of subjects with changes on ECG.
Secondary Outcome:
Plasma concentration (Cmax)
Time to achieve Cmax (tmax)
Area under the plasma concentration-time curve (AUC)
Objective response rate
Duration of overall response
Progression-free survival
Duration of stable disease
Estimated Enrollment
158
Study Start Date
August 27, 2018
Eligibility
Gender: All
Minimum Age: 18 Years
Maximum Age: 100 Years
Health Volunteers: No
Criteria
Amgen
Information Provided By
Amgen
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
Clinicaltrials.gov Identifier
NCT03600883

 

 

Source: Clinicaltrials.gov. Through our founding membership in the Dana-Farber/Harvard Cancer Center, an NCI-designated Comprehensive Cancer Center, these clinical trials are conducted at the Massachusetts General Hospital Cancer Center and may be available at other partner institutions.

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