NCT07172919 · Amgen
A Rollover Study Evaluating Sotorasib With or Without Panitumumab in Participants With KRAS p.G12C Mutation
What this study is about
The primary objective of the study is to evaluate the safety and how well patients handle the treatment of the continuation of sotorasib with or without panitumumab and/or other anti-cancer therapies in participants continuing to derive benefit in Amgen-sponsored protocols.
View original scientific description
The primary objective of the study is to evaluate the safety and tolerability of the continuation of sotorasib with or without panitumumab and/or other anti-cancer therapies in participants continuing to derive benefit in Amgen-sponsored protocols.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Signed informed consent.
- Age ≥ 18 years.
- Life expectancy of \> 3 months, in the opinion of the investigator.
- Ability to take oral medications and willing to record daily adherence to sotorasib through the use of a written diary.
- Participant is currently receiving treatment with sotorasib alone or in combination therapy in an Amgen-sponsored trial that has met its endpoints or otherwise will be stopping (also referred to as parent study) and are continuing to receive clinical benefit in the opinion of the investigator.
- For a participant on combination therapy in their parent study, treatment with other anti-cancer therapies is allowed provided it matches the parent study.
- Eastern Cooperative Oncology Group Performance Status of ≤ 2.
Exclusion criteria
- Participant had permanently discontinued from sotorasib study treatment in the parent study before the parent study's completion.
- Ongoing, unresolved toxicity requiring interruption of sotorasib treatment at the time of the termination of the parent study.
- Local access to commercially available investigational product(s) at no cost to the participant as permitted by local/country regulation.
- Anticipated toxicities of sotorasib study treatment outweigh the clinical benefit to the participant in the opinion of the investigator.
- Participant unlikely to be able to complete all protocol-required procedures, restrictions and requirements, in the judgment of the individual and investigator.
- Significant uncontrolled concomitant disease that could affect compliance with protocol procedures or interpretation of results or that pose a risk to participant safety, in the opinion of the investigator.
- Female participants of childbearing potential unwilling to use protocol-specified method of contraception during treatment and for an additional:
- 7 days after the last dose of sotorasib.
- 2 months after the last dose of panitumumab.
- Female participants who are breastfeeding or who plan to breastfeed while on study through:
- 7 days after the last dose of sotorasib.
- 2 months after the last dose of panitumumab.
- Female participants planning to become pregnant while on study through:
- 7 days after the last dose of sotorasib.
- 2 months after the last dose of panitumumab.
- Female participants of childbearing potential with a positive pregnancy test assessed at screening or day 1 by a highly sensitive urine or serum pregnancy test.
- Male participants with a female partner of childbearing potential who are unwilling to practice sexual abstinence (refrain from heterosexual intercourse) or use contraception during treatment and for an additional 7 days after the last dose of sotorasib.
- Male participants with a pregnant partner who are unwilling to practice abstinence or use a condom during treatment and for an additional 7 days after the last dose of sotorasib.
- Male participants unwilling to abstain from donating sperm during treatment and for an additional 7 days after the last dose of sotorasib.
Where
- Fort Myers, Florida
- Houston, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 14, 2026 · Source of record for eligibility and locations