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NCT04185883 · ClinicalTrials.gov registry record · Phase 1

Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)

A Phase 1 study of Advanced Solid Tumors and Kirsten Rat Sarcoma (KRAS) pG12C Mutation, sponsored by Amgen.

Active
Registry status
Phase 1
Development phase
610
Enrollment target
20
Study locations

NCT04185883 is a Phase 1 study of Advanced Solid Tumors and Kirsten Rat Sarcoma (KRAS) pG12C Mutation that is active but no longer recruiting, run by Amgen. The registered enrollment target is 610 participants, above the 194-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (214% higher). The trial reports 20 study locations across 10 states.

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The verdict

NCT04185883, a Phase 1 study of Advanced Solid Tumors and Kirsten Rat Sarcoma (KRAS) pG12C Mutation, is active but no longer recruiting, sponsored by Amgen.

ACTIVE NOT RECRUITING
Registry status
Phase 1
Development phase
610 participants
Enrollment target
20
Study locations

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

Advanced Solid Tumors Kirsten Rat Sarcoma (KRAS) pG12C Mutation

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

FieldValue
Enrollment Target 610 participants
Start Date 2019-12-17
Est. Completion 2027-12-05
Phase Phase 1

Sponsor

Amgen

558 total trials

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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, categorized as Phase 1. The registered enrollment target is 610 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 194-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (214% higher). The listed sponsor is Amgen, which has 558 total studies on file at ClinicalTrials.gov.

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.

NCT04185883 reports 20 study locations spanning 10 distinct geographic areas - top geographies include California, Colorado, Connecticut.

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.

What interventions are being tested in trial NCT04185883?

The interventions under investigation include: Pembrolizumab (DRUG), Trametinib (DRUG), Afatinib (DRUG), Sotorasib (DRUG), RMC-4630 (DRUG).

Who is sponsoring clinical trial NCT04185883?

This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.