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New treatment option for Advanced Solid Tumors
Official title A Rollover Study Evaluating Sotorasib With or Without Panitumumab in Participants With KRAS p.G12C Mutation
ClinicalTrials.gov ID: NCT07172919
What this study is testing
What is Sotorasib?
Sotorasib is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for advanced solid tumors.
Also referred to as AMG 510.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
You likely can't join if
- 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...
- Significant uncontrolled concomitant disease that could affect compliance with protocol procedures or interpretation of results or that pose a risk...
See the full eligibility 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...
- 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Fort Myers, Florida, United States
- Houston, Texas, United States
- Randwick, New South Wales, Australia
- Lyon, France
- Berlin, Germany
- Athens, Greece
- Thessaloniki, Greece
- Roma, Italy
- Sapporo, Hokkaido, Japan
- Basel, Switzerland
- Taichung, Taiwan
Compensation & support
Some study costs may be covered.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fort Myers, Florida, United States; Houston, Texas, United States; Randwick, New South Wales, Australia; Lyon, France; Berlin, Germany; Athens, Greece and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.