Summary

Eligibility
for people ages 18-100 (full criteria)
Location
at La Jolla, California and other locations
Dates
study started
estimated completion

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/2, 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 Bevacizumab Pembrolizumab Panitumumab Carboplatin Docetaxel Pemetrexed Everolimus Atezolizumab Palbociclib Trametinib Afatinib Loperamide Sotorasib AMG 404 RMC-4630 carboplatin, pemetrexed, docetaxel MVASI® (bevacizumab-awwb) TNO155 FOLFIRI FOLFOX Sotorasib + trametinib Sotorasib + AMG 404 Sotorasib + RMC-4630 Sotorasib + afatinib Sotorasib + pembrolizumab Sotorasib + panitumumab +/- FOLFIRI Sotorasib + atezolizumab Sotorasib + carboplatin, pemetraxed, docetaxel Sotorasib Monotherapy Sotorasib + palbociclib Sotorasib + everolimus Sotorasib + trametinib+ panitumumab Sotorasib + TNO155 Sotorasib + afatinib + loperamide

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.

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 San Diego Moores Cancer Center accepting new patients
    La Jolla California 92093 United States
  • Loma Linda University Cancer Center accepting new patients
    Loma Linda California 92354 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Amgen
Links
AmgenTrials clinical trials website
ID
NCT04185883
Phase
Phase 1/2
Study Type
Interventional
Last Updated