This study is in progress, not accepting new patients

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

a study on Solid Tumor Sarcoma

Summary

Eligibility
for people ages 18-100 (full criteria)
Location
at San Francisco 5391959, California 5332921 and other locations
Dates
study started
study ends 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, sotorasib, trametinib, Afatinib, pembrolizumab, Panitumumab, Carboplatin, Pemetrexed, Docetaxel, Paclitaxel, atezolizumab, palbociclib, Bevacizumab, Drug Therapy, Everolimus, 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
    San Francisco 5391959 California 5332921 94115 United States
  • University of California Davis Medical Center
    Sacramento 5389489 California 5332921 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
in progress, not 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
About 610 people participating
Last Updated