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Recruiting NCT07172919

A Rollover Study Evaluating Sotorasib With or Without Panitumumab in Participants With KRAS p.G12C Mutation

Phase II Interventional Advanced Solid Tumors

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sotorasib, Panitumumab.
Who it may be relevant to
Registry conditions: Advanced Solid Tumors. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Australia, France, Germany, Greece +4
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Sotorasib
    Sotorasib will be administered orally as a tablet.
  • Drug Panitumumab
    Panitumumab will be administered as an IV infusion.

Primary outcome measures

  • Number of Participants with Treatment-Emergent Adverse Events (TEAEs) [Time frame: Up to approximately 18 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 2 centers
  • Florida Cancer Specialists - Fort Myers — Fort Myers
  • University of Texas MD Anderson Cancer Center — Houston
Greece · 2 centers
  • Henry Dunant Hospital Center — Athens
  • Theagenion Cancer Hospital — Thessaloniki
Australia · 1 center
  • Scientia Clinical Research Ltd — Randwick
France · 1 center
  • Centre Leon Berard — Lyon
Germany · 1 center
  • Evangelische Lungenklinik — Berlin
Italy · 1 center
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Roma
Japan · 1 center
  • National Hospital Organization Hokkaido Cancer Center — Sapporo
Switzerland · 1 center
  • Universitaetsspital Basel — Basel
Taiwan · 1 center
  • Taichung Veterans General Hospital — Taichung

Identifiers

NCT: NCT07172919 · 20250089 · 2025-522355-26 · U1111-1322-4422

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗