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
| Parameter | Options |
|---|
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
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Florida Cancer Specialists - Fort Myers | 33901 | Fort Myers | Florida |
| University of Texas MD Anderson Cancer Center | 77030 | Houston | Texas |
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