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Regorafenib in Newly Diagnosed Metastatic Colorectal Adenocarcinoma
NCT02023333Phase 2
Key facts
- Status
- Completed
- Start
- Dec 2013
- Primary completion
- Aug 2025
- Countries
- 1
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Modality
- Small Molecules
- Drugs
- regorafenib
- Conditions
- colorectal adenocarcinoma
01
Overview
Phase 2, open-label, single-arm trial of regorafenib in colorectal adenocarcinoma, sponsored by Memorial Sloan Kettering Cancer Center. Primary endpoint: Progression Free Survival at 16 weeks. Started Dec 2013; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Regorafenib
Regorafenib daily 3 weeks on 1 week off
03
Who it enrols
Adults with untreated or first-line progressed metastatic colorectal adenocarcinoma, ECOG 0-1, adequate organ function, no active cardiac disease, uncontrolled hypertension, or recent major surgery.
04
Endpoints
Primary
Progression Free Survival
Secondary
Overall Survival
Disease Control Rate
Number of Participants With Stable Disease
Number of Participants Evaluated for Toxicity
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