Phase 2: testing Sotorasib for Advanced Solid Tumors
The primary objective of the study is to measure the whether it is safe and how hard side effects are to live with 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.
Official registry: https://clinicaltrials.gov/study/NCT07172919 · Amgen · enrollment listed as 14
What this phase means
Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Sotorasib, or Panitumumab. The registry lists allocation as randomized. The primary objective of the study is to measure the whether it is safe and how hard side effects are to live with 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.
They plan to enroll about 14 people at 11 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
A Rollover Study of Sotorasib With or Without Panitumumab for the Treatment of Cancer Subjects With KRAS p.G12C Mutation Previously Treated in an Amgen-Sponsored Study
Interventions: Sotorasib, Panitumumab
Primary outcome (registry wording): Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Who it is for (from inclusion criteria)
- Ages 18 Years to any
- 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
- 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
Who the registry excludes
- 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:
Public study contact (from the registry)
Amgen Call Center
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
11 listed- Florida Cancer Specialists - Fort Myers — Fort Myers, Florida (recruiting)
- University of Texas MD Anderson Cancer Center — Houston, Texas (recruiting)
+ 9 sites outside the US on the same record
FAQ about this NCT record
Is NCT07172919 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07172919?
Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07172919?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
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