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ACTIVE NOT RECRUITING 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)

NCT03600883 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 713 participants
Start Date 2018-08-27
Est. Completion 2026-05-30
Phase Phase 1

Sponsor

Amgen

266 total trials

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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. 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 713 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 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. 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: NCT03600883 reports 20 study locations spanning 12 distinct geographic areas — top geographies include California, Florida, Colorado. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03600883?

The interventions under investigation include: Midazolam (DRUG), sotorasib (DRUG), Anti PD-1/L1 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03600883?

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 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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial