Study on Continuing Sotorasib Treatment With or Without Panitumumab for Patients With KRAS p.G12C Mutation

Sponsor: Amgen

Sponsor score: 60

ClinicalTrials ID:NCT07172919

This study is examining the safety of continuing sotorasib treatment, with or without panitumumab, for patients who have been benefiting from it in previous Amgen-sponsored trials.

Patient Parameters

Program Overview

The main goal of this study is to see if continuing the use of sotorasib, either alone or with panitumumab and other cancer treatments, is safe and well-tolerated in patients who have been benefiting from it in previous studies sponsored by Amgen.

Eligibility Criteria

Inclusion Criteria

  • Must provide signed informed consent.
  • Must be 18 years or older.
  • Must have a life expectancy of more than 3 months, as assessed by the study doctor.
  • Must be able to take oral medications and agree to keep a daily diary of taking sotorasib.
  • Must currently be receiving sotorasib treatment, alone or with other therapies, in an Amgen-sponsored study that is ending, and still benefiting from it according to the study doctor.
  • If on combination therapy, must continue with the same additional treatments as in the previous study.
  • Must have a performance status score of 2 or less, indicating full activity or some restriction in strenuous activities.

Exclusion Criteria

  • Have stopped sotorasib treatment permanently in the previous study before it ended.
  • Have ongoing side effects that require stopping sotorasib at the end of the previous study.
  • Have access to the study drugs for free locally, as allowed by local regulations.
  • If the potential side effects of sotorasib outweigh the benefits, as judged by the study doctor.
  • Unlikely to complete all study procedures and requirements, as judged by the study doctor.
  • Have other uncontrolled health issues that could interfere with the study or pose a risk, as judged by the study doctor.
  • Women who can become pregnant must agree to use contraception during treatment and for:
    • 7 days after the last dose of sotorasib.
    • 2 months after the last dose of panitumumab.
  • Women who are breastfeeding or plan to breastfeed must stop during treatment and for:
    • 7 days after the last dose of sotorasib.
    • 2 months after the last dose of panitumumab.
  • Women planning to become pregnant must wait until:
    • 7 days after the last dose of sotorasib.
    • 2 months after the last dose of panitumumab.
  • Women who can become pregnant must have a negative pregnancy test before starting the study.
  • Men with partners who can become pregnant must agree to use contraception or abstain from sex during treatment and for 7 days after the last dose of sotorasib.
  • Men with pregnant partners must agree to use a condom or abstain from sex during treatment and for 7 days after the last dose of sotorasib.
  • Men must agree not to donate sperm during treatment and for 7 days after the last dose of sotorasib.

Locations

FACILITYZIPCITYSTATE
Florida Cancer Specialists - Fort Myers33901Fort MyersFlorida
University of Texas MD Anderson Cancer Center77030HoustonTexas

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