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Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)
NCT04185883 · View on ClinicalTrials.gov ↗
Study Summary
To evaluate the safety and tolerability of sotorasib administered in investigational regimens in adult participants with KRAS p.G12C mutant advanced solid tumors.
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Trametinib
- DRUG Afatinib
- DRUG Sotorasib
- DRUG RMC-4630
Study Locations (20)
California
- City of Hope National Medical Center — Duarte
- University of California San Diego Moores Cancer Center — La Jolla
- Loma Linda University Cancer Center — Loma Linda
- University of Southern California, Norris Comprehensive Cancer Center — Los Angeles
- University of California Davis Medical Center — Sacramento
- University of California San Francisco Mission Bay Campus — San Francisco
- University of California Los Angeles — Santa Monica
Colorado
- Rocky Mountain Cancer Centers Denver Midtown — Denver
- Sarah Cannon Research Institute — Denver
Connecticut
- Yale New Haven Hospital — New Haven
- Norwalk Hospital — Norwalk
Florida
- Memorial Cancer Institute — Pembroke Pines
- Moffitt Cancer Center — Tampa
Illinois
- Northwestern University — Chicago
- University of Chicago — Chicago
Arizona
- Arizona Oncology Associates Professional Corporation — Tucson
Georgia
- Emory University — Atlanta
Indiana
- Indiana University — Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 610 participants |
| Start Date | 2019-12-17 |
| Est. Completion | 2027-12-05 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04185883
The ClinicalTrials.gov registry entry for NCT04185883 describes a study currently listed as active not recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 610 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amgen, which has 266 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Advanced Solid Tumors appearing as the primary indexed condition, and to 5 interventions — of which Pembrolizumab is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04185883 reports 20 study locations spanning 10 distinct geographic areas — top geographies include California, Colorado, Connecticut. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04185883 about?
NCT04185883 is a clinical study titled "Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)". To evaluate the safety and tolerability of sotorasib administered in investigational regimens in adult participants with KRAS p.G12C mutant advanced solid tumors.
What is the current status of trial NCT04185883?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 610 participants. The study started on 2019-12-17. Estimated completion is 2027-12-05.
What conditions does trial NCT04185883 study?
This clinical trial studies the following conditions: Advanced Solid Tumors, Kirsten Rat Sarcoma (KRAS) pG12C Mutation. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04185883?
The interventions under investigation include: Pembrolizumab (DRUG), Trametinib (DRUG), Afatinib (DRUG), Sotorasib (DRUG), RMC-4630 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04185883?
This trial is sponsored by Amgen, which has 266 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04185883 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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