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NCT03600883 · ClinicalTrials.gov registry record · Phase 1
A Phase 1/2, Study Evaluating the Safety, Tolerability, PK, and Efficacy of Sotorasib (AMG 510) in Subjects With Solid Tumors With a Specific KRAS Mutation (CodeBreaK 100)
A Phase 1 study of KRAS p.G12C Mutant Advanced Solid Tumors, sponsored by Amgen.
- Active
- Registry status
- Phase 1
- Development phase
- 713
- Enrollment target
- 20
- Study locations
NCT03600883 is a Phase 1 study of KRAS p.G12C Mutant Advanced Solid Tumors that is active but no longer recruiting, run by Amgen. The registered enrollment target is 713 participants. The trial reports 20 study locations across 12 states.
The verdict
NCT03600883, a Phase 1 study of KRAS p.G12C Mutant Advanced Solid Tumors, is active but no longer recruiting, sponsored by Amgen.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 713 participants
- Enrollment target
- 20
- Study locations
Study Summary
Evaluate the safety and tolerability of sotorasib 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.
Conditions Studied
Interventions
- DRUG Midazolam
- DRUG sotorasib
- DRUG Anti PD-1/L1
Study Locations (20)
California
- City of Hope National Medical Center - Duarte
- University of California Los Angeles - Los Angeles
- University of California at SF - San Francisco
- Sarcoma Oncology Research Center LLC - Santa Monica
Florida
- University of Florida Health - Gainesville
- AdventHealth Orlando Infusion Center - Orlando
- Moffitt Cancer Center - Tampa
Colorado
- Rocky Mountain Cancer Centers - Denver
- Sarah Cannon Research Institute at HealthONE - Denver
Massachusetts
- Massachusetts General Hospital - Boston
- Dana Farber Cancer Institute - Boston
Michigan
- University of Michigan - Ann Arbor
- Henry Ford Health System - Detroit
Connecticut
- Smilow Cancer Hospital at Yale New Haven - New Haven
Delaware
- Medical Oncology Hematology Consultants Helen F Graham Cancer Center - Newark
Georgia
- Winship Cancer Institute - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 713 participants |
| Start Date | 2018-08-27 |
| Est. Completion | 2026-05-30 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03600883
The ClinicalTrials.gov registry entry for NCT03600883 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 713 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amgen, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with KRAS p.G12C Mutant Advanced Solid Tumors appearing as the primary indexed condition, and to 3 interventions - of which Midazolam is the first listed.
NCT03600883 reports 20 study locations spanning 12 distinct geographic areas - top geographies include California, Florida, Colorado.
Frequently Asked Questions
What is clinical trial NCT03600883 about?
NCT03600883 is a clinical study titled "A Phase 1/2, Study Evaluating the Safety, Tolerability, PK, and Efficacy of Sotorasib (AMG 510) in Subjects With Solid Tumors With a Specific KRAS Mutation (CodeBreaK 100)". Evaluate the safety and tolerability of sotorasib 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.
What is the current status of trial NCT03600883?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 713 participants. The study started on 2018-08-27. Estimated completion is 2026-05-30.
What conditions does trial NCT03600883 study?
This clinical trial studies the following conditions: KRAS p.G12C Mutant Advanced Solid Tumors.
What interventions are being tested in trial NCT03600883?
The interventions under investigation include: Midazolam (DRUG), sotorasib (DRUG), Anti PD-1/L1 (DRUG).
Who is sponsoring clinical trial NCT03600883?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03600883 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, Delaware, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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