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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: Active Phase 1 study of KRAS p.G12C Mutant Advanced Solid Tumors, sponsored by Amgen.
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, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (1088% higher). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Treatment-emergent adverse events will be a primary outcome measure for the following groups: * Phase 1 Dose Exploration Part 1 monotherapy * Phase 1 Dose Expansion Part 2 monotherapy * Phase 1 combination arm with sotorasib and anti PD-1/L1 * Phase 1 monotherapy treatment naïve advanced NSCLC * Phase 2 monotherapy dose comparison
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 |
What the registry record for NCT03600883 still lists
NCT03600883 is an interventional study that assigns participants to a tested intervention. The registered 713 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (1088% higher).
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 names 20 study sites across 12 states, led by 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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03600883's enrollment target sits among peer trials
713 19th of 2000 higher than 1,982 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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