ACTIVE_NOT_RECRUITING

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

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Conditions

Advanced Solid TumorsKirsten Rat Sarcoma (KRAS) pG12C Mutation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

To evaluate the safety and tolerability of sotorasib administered in investigational regimens in adult participants with KRAS p.G12C mutant advanced solid tumors.

Official Title

A Phase 1b, Protocol Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Sotorasib Monotherapy and in Combination With Other Anti-cancer Therapies in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)

Quick Facts

Study Start:2019-12-17
Study Completion:2027-12-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04185883

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Men or women greater than or equal to 18 years old.
  2. * Pathologically documented, locally-advanced or metastatic malignancy with, KRAS p.G12C mutation identified through molecular testing performed according to in-country requirements. In the United States, this test must be performed in a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory.
  1. * Primary brain tumor.
  2. * Spinal cord compression, or untreated, or symptomatic, or active brain metastases, or leptomeningeal disease from non-brain tumors.
  3. * Myocardial infarction within 6 months of study day 1.
  4. * Gastrointestinal (GI) tract disease causing the inability to take oral medication.

Contacts and Locations

Principal Investigator

MD
STUDY_DIRECTOR
Amgen

Study Locations (Sites)

Arizona Oncology Associates Professional Corporation
Tucson, Arizona, 85711
United States
City of Hope National Medical Center
Duarte, California, 91010
United States
University of California San Diego Moores Cancer Center
La Jolla, California, 92093
United States
Loma Linda University Cancer Center
Loma Linda, California, 92354
United States
University of Southern California, Norris Comprehensive Cancer Center
Los Angeles, California, 90033
United States
University of California Davis Medical Center
Sacramento, California, 95817
United States
University of California San Francisco Mission Bay Campus
San Francisco, California, 94115
United States
University of California Los Angeles
Santa Monica, California, 90404
United States
Rocky Mountain Cancer Centers Denver Midtown
Denver, Colorado, 80218
United States
Sarah Cannon Research Institute
Denver, Colorado, 80218
United States
Yale New Haven Hospital
New Haven, Connecticut, 06520
United States
Norwalk Hospital
Norwalk, Connecticut, 06856
United States
Memorial Cancer Institute
Pembroke Pines, Florida, 33028
United States
Moffitt Cancer Center
Tampa, Florida, 33612
United States
Emory University
Atlanta, Georgia, 30322
United States
Northwestern University
Chicago, Illinois, 60611
United States
University of Chicago
Chicago, Illinois, 60637
United States
Indiana University
Indianapolis, Indiana, 46202
United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
United States
Johns Hopkins University
Baltimore, Maryland, 21224
United States
University of Michigan
Ann Arbor, Michigan, 48109-5912
United States
Henry Ford Cancer Detroit (Brigitte Harris Cancer Pavilion)
Detroit, Michigan, 48202
United States
Washington University
St Louis, Missouri, 63110-1093
United States
Roswell Park Cancer Institute
Buffalo, New York, 32224
United States
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
United States
Columbia University Irving Medical Center
New York, New York, 10032
United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
United States
Montefiore Medical Center
The Bronx, New York, 10461
United States
Levine Cancer Institute
Charlotte, North Carolina, 28204
United States
Duke University
Durham, North Carolina, 27710
United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45267
United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
United States
Providence Portland Medical Center
Portland, Oregon, 97213
United States
Oregon Health and Science University
Portland, Oregon, 97239
United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19111
United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15232
United States
Gibbs Cancer Center and Research Institute - Spartanburg
Spartanburg, South Carolina, 29303
United States
Avera Cancer Institute
Sioux Falls, South Dakota, 57108
United States
United States Oncology Regulatory Affairs Corporate Office
Nashville, Tennessee, 37203
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
United States
Texas Oncology Central-South
Austin, Texas, 78705
United States
Mary Crowley Cancer Research
Dallas, Texas, 75230
United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
United States
Oncology Consultants
Houston, Texas, 77030
United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
United States
US Oncology Research Investigational Products Center
The Woodlands, Texas, 77380
United States
Texas Oncology Northeast Texas
Tyler, Texas, 75702
United States
Huntsman Cancer Institute
Salt Lake City, Utah, 84112
United States
University of Virginia Cancer Center
Charlottesville, Virginia, 22903
United States
Virginia Cancer Specialists, PC
Fairfax, Virginia, 22031
United States
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
United States
Northwest Medical Specialties, PLLC
Tacoma, Washington, 98405
United States
Northwest Cancer Specialists - Vancouver
Vancouver, Washington, 98684
United States

Collaborators and Investigators

Sponsor: Amgen

  • MD, STUDY_DIRECTOR, Amgen

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-12-17
Study Completion Date2027-12-05

Study Record Updates

Study Start Date2019-12-17
Study Completion Date2027-12-05

Terms related to this study

Additional Relevant MeSH Terms

  • Advanced Solid Tumors
  • Kirsten Rat Sarcoma (KRAS) pG12C Mutation