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NCT05198934 · ClinicalTrials.gov registry record · Phase 3
Sotorasib and Panitumumab Versus Investigator's Choice for Participants With Kirsten Rat Sarcoma (KRAS) p.G12C Mutation
A Phase 3 study of Colorectal Cancer (CRC), sponsored by Amgen.
- Active
- Registry status
- Phase 3
- Development phase
- 160
- Enrollment target
- 20
- Study locations
NCT05198934: Active Phase 3 study of Colorectal Cancer (CRC), sponsored by Amgen.
NCT05198934 is a Phase 3 study of Colorectal Cancer (CRC) that is active but no longer recruiting, run by Amgen. The registered enrollment target is 160 participants, below the 394-participant average among 19 other Colorectal Cancer (CRC) trials with a reported enrollment target (59% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05198934, a Phase 3 study of Colorectal Cancer (CRC), is active but no longer recruiting, sponsored by Amgen.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 160 participants
- Enrollment target
- 20
- Study locations
Study Summary
The aim of the study is to compare progression-free survival (PFS) in previously treated participants with Kirsten rat sarcoma (KRAS) p.G12C mutated colorectal cancer (CRC) receiving sotorasib 240 mg once daily (QD) and panitumumab vs investigator's choice (trifluridine and tipiracil, or regorafenib), and sotorasib 960 mg QD and panitumumab vs investigator's choice (trifluridine and tipiracil, or regorafenib).
Primary Outcome
PFS was defined as time from randomization until disease progression or death from any cause, whichever occurred first, for all participants. Progression was assessed using RECIST v1.1 per BICR.
Conditions Studied
Interventions
- DRUG Regorafenib
- DRUG Sotorasib
- DRUG Panitumumab
- DRUG Trifluridine and Tipiracil
Study Locations (20)
Michigan
- University of Michigan - Ann Arbor
- Revive Research Institute - Farmington Hills
- Sparrow Clinical Research Institute - Lansing
- Revive Research Institute - Sterling Heights
Texas
- Kelsey Research Foundation - Houston
- Best Cancer Care & Hematology - Houston
- Lumi Research - Kingwood
California
- City of Hope National Medical Center - Duarte
- University of California Irvine - Orange
Florida
- Cancer Specialists of North Florida - Jacksonville
- Lakes Research LLC - Miami Lakes
New York
- Upstate University Hospital - Syracuse
- White Plains Hospital Center for Cancer Care - White Plains
Alabama
- Central Alabama Research - Birmingham
District of Columbia
- Johns Hopkins University School of Medicine - Washington D.C.
Georgia
- Northwest Georgia Oncology Centers PC - Marietta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2022-04-19 |
| Est. Completion | 2026-05-14 |
| Phase | Phase 3 |
What the registry record for NCT05198934 still lists
NCT05198934 is an interventional study that assigns participants to a tested intervention. The registered 160 participants enrollment target is mid-sized for trials with a published cap, below the 394-participant average among 19 other Colorectal Cancer (CRC) trials with a reported enrollment target (59% lower).
The record links to 1 condition, with Colorectal Cancer (CRC) appearing as the primary indexed condition, and to 4 interventions - of which Regorafenib is the first listed.
NCT05198934 names 20 study sites across 12 states, led by Michigan, Texas, California.
Frequently Asked Questions
What is clinical trial NCT05198934 about?
NCT05198934 is a clinical study titled "Sotorasib and Panitumumab Versus Investigator's Choice for Participants With Kirsten Rat Sarcoma (KRAS) p.G12C Mutation". The aim of the study is to compare progression-free survival (PFS) in previously treated participants with Kirsten rat sarcoma (KRAS) p.G12C mutated colorectal cancer (CRC) receiving sotorasib 240 mg once daily (QD) and panitumumab vs investigator's choice (trifluridine and tipiracil, or regorafenib...
What is the current status of trial NCT05198934?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 160 participants. The study started on 2022-04-19. Estimated completion is 2026-05-14.
What conditions does trial NCT05198934 study?
This clinical trial studies the following conditions: Colorectal Cancer (CRC).
What interventions are being tested in trial NCT05198934?
The interventions under investigation include: Regorafenib (DRUG), Sotorasib (DRUG), Panitumumab (DRUG), Trifluridine and Tipiracil (DRUG).
Who is sponsoring clinical trial NCT05198934?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05198934 being conducted?
This trial has 20 study locations across Alabama, California, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Colorectal Cancer (CRC)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05198934's enrollment target sits among peer trials
160 14th of 19 higher than 6 of 19 other Colorectal Cancer (CRC) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Colorectal Cancer (CRC) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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