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

a study on Solid Tumor Sarcoma Neoplasms

Summary

Eligibility
for people ages 18-100 (full criteria)
Location
at Santa Monica, California and other locations
Dates
study started
completion around
Principal Investigator
by Jonathan Goldman

Description

Summary

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)

Keywords

Advanced Solid Tumors, Kirsten Rat Sarcoma (KRAS) pG12C Mutation, Neoplasms, Sarcoma, Docetaxel, Bevacizumab, Carboplatin, Pembrolizumab, Pemetrexed, Everolimus, Atezolizumab, Palbociclib, Panitumumab, Trametinib, Afatinib, Sotorasib, RMC-4630, Carboplatin, pemetrexed, docetaxel, paclitaxel, MVASI® (bevacizumab-awwb), TNO155, IV Chemotherapy (Regimen 1), IV Chemotherapy (Regimen 2), AMG 404, Sotorasib + trametinib + panitumumab, Sotorasib + RMC-4630, Sotorasib + afatinib, Sotorasib + atezolizumab, Sotorasib + carboplatin, pemetrexed, docetaxel, paclitaxel, pembrolizumab, Sotorasib Monotherapy, Sotorasib + palbociclib, Sotorasib + pembrolizumab, Sotorasib + MVASI® (bevacizumab-awwb)+ Chemotherapy, Sotorasib + TNO155, Sotorasib + BI 1701963, Sotorasib + AMG 404, Sotorasib + everolimus

Eligibility

You can join if…

Open to people ages 18-100

  • Men or women greater than or equal to 18 years old.
  • 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.

You CAN'T join if...

  • Primary brain tumor.
  • Spinal cord compression, or untreated, or symptomatic, or active brain metastases, or leptomeningeal disease from non-brain tumors.
  • Myocardial infarction within 6 months of study day 1.
  • Gastrointestinal (GI) tract disease causing the inability to take oral medication.

Locations

  • University of California Los Angeles accepting new patients
    Santa Monica California 90404 United States
  • University of Southern California, Norris Comprehensive Cancer Center accepting new patients
    Los Angeles California 90033 United States
  • City of Hope National Medical Center accepting new patients
    Duarte California 91010 United States

Lead Scientist at UCLA

  • Jonathan Goldman
    Hs Clinical Professor, Medicine. Authored (or co-authored) 110 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Amgen
Links
AmgenTrials clinical trials website Sign up for this study
ID
NCT04185883
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 1200 study participants
Last Updated
Contact us about this trial