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

Part of paid clinical trials in Fort Myers, Florida.

Sponsor
Amgen
Study ID
NCT07172919
Phase
PHASE2
Status
Recruiting
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Conditions

  • Advanced Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jan 2, 2026
Status verified
May 2026
Primary completion
Jan 2, 2028
Completion
Jan 2, 2028

Study Design

Enrollment
14 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A: Sotorasib
    Sotorasib will be administered once daily, orally in 28-day treatment cycles for up to approximately 18 months or until withdrawal of consent, lost to follow-up, or death, whichever occurs first.
  • Experimental: Arm B: Sotorasib in Combination with Panitumumab
    Sotorasib will be administered once daily, orally, in combination with Panitumumab intravenous (IV) infusion every two weeks on Day 1 and Day 15 in 28-day treatment cycles. Treatment will continue for up to approximately 18 months or until withdrawal of consent, lost to follow-up, or death, whichever occurs first.

Primary Outcome Measure

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

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Florida Cancer Specialists - Fort MyersFort MyersFlorida33901-
University of Texas MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Fort Myers, FL

By research site
Florida Cancer Specialists - Fort Myers· Fort Myers, FLUniversity of Texas MD Anderson Cancer Center· Houston, TX

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