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 San Francisco, California and other locations
Dates
study started
completion around
Principal Investigator
by Matthew Gubens
Headshot of Matthew Gubens
Matthew Gubens

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

  • UCSF Mission Bay Campus accepting new patients
    San Francisco California 94115 United States
  • University of California Davis Medical Center accepting new patients
    Sacramento California 95817 United States

Lead Scientist at UCSF

  • Matthew Gubens
    Matthew Gubens, MD, MS, FASCO is Professor of Medicine at UCSF, where he practices as a thoracic medical oncologist and serves as Medical Director of Thoracic Medical Oncology. He is also Chair of the UCSF Cancer Center Protocol Review and Monitoring Committee which oversees scientific review of clinical cancer research at the institution.

Details

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