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NCT01271712 · ClinicalTrials.gov registry record · Phase 3
Study of Regorafenib as a 3rd-line or Beyond Treatment for Gastrointestinal Stromal Tumors (GIST)
A Phase 3 study of Gastrointestinal Stromal Tumors, sponsored by Bayer.
- Completed
- Registry status
- Phase 3
- Development phase
- 199
- Enrollment target
- 20
- Study locations
NCT01271712: Completed Phase 3 study of Gastrointestinal Stromal Tumors, sponsored by Bayer.
NCT01271712 is a Phase 3 study of Gastrointestinal Stromal Tumors that has completed, run by Bayer. The registered enrollment target is 199 participants, above the 75-participant average among 10 other Gastrointestinal Stromal Tumors trials with a reported enrollment target (165% higher). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01271712, a Phase 3 study of Gastrointestinal Stromal Tumors, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 199 participants
- Enrollment target
- 20
- Study locations
Study Summary
A randomized, double-blind, placebo-controlled phase III study of regorafenib plus best supportive care versus placebo plus best supportive care for subjects with metastatic and/or unresectable gastrointestinal stromal tumors (GIST) whose disease has progressed despite prior treatment with at least imatinib and sunitinib. The study is composed of 3 periods: A Screening Period, a Treatment Period, and a Survival Follow up Period. Subjects randomized to be treated with regorafenib will receive 160 mg po od for 3 weeks of every 4 week (28 day) cycle (ie, 3 weeks on/1 week off). In addition subjects will receive best supportive care which excludes any disease specific anti cancer therapy such as any kinase inhibitor, chemotherapy, radiation therapy, or surgery. Tumor assessment will be every 4 weeks for the first 3 months, every 6 weeks for the next 3 months (through month 6), and every 8 weeks until the end of treatment, or more frequently if clinically indicated. Tumor assessments include CT or MRI and will be performed until tumor progression is seen in a central radiology review. Subjects receiving placebo who experience disease progression may be offered active treatment. Subjects who experience progression during regorafenib treatment may continue open label treatment. All subjects will enter the Survival Follow-up Period upon discontinuation of randomized study treatment.
Primary Outcome
Progression-free Survival (PFS) was defined as the time from date of randomization to radiological disease progression or death due to any cause, whichever occurs first. PFS was based on central radiological assessment using modified RECIST (Response Evaluation Criteria in Solid Tumors) v.1.1. Progression is defined as at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on study; or unequivocal progression of existing non-target lesions; or appe
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Regorafenib (Stivarga, BAY73-4506)
- DRUG Best supportive care
Study Locations (20)
Other
- - Innsbruck
- - Vienna
- - Leuven
- - Beijing
- - Shanghai
Illinois
- - Evanston
- - Skokie
Ontario
- - London
- - Toronto
Arizona
- - Scottsdale
Massachusetts
- - Boston
Minnesota
- - Minneapolis
New York
- - New York
Oregon
- - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 199 participants |
| Start Date | 2011-01-04 |
| Est. Completion | 2019-04-15 |
| Phase | Phase 3 |
What the finished NCT01271712 record still lists
NCT01271712 is an interventional study that assigns participants to a tested intervention. The registered 199 participants enrollment target is mid-sized for trials with a published cap, above the 75-participant average among 10 other Gastrointestinal Stromal Tumors trials with a reported enrollment target (165% higher).
The record links to 1 condition, with Gastrointestinal Stromal Tumors appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT01271712 names 20 study sites across 14 states, led by Other, Illinois, Ontario.
Frequently Asked Questions
What is clinical trial NCT01271712 about?
NCT01271712 is a clinical study titled "Study of Regorafenib as a 3rd-line or Beyond Treatment for Gastrointestinal Stromal Tumors (GIST)". A randomized, double-blind, placebo-controlled phase III study of regorafenib plus best supportive care versus placebo plus best supportive care for subjects with metastatic and/or unresectable gastrointestinal stromal tumors (GIST) whose disease has progressed despite prior treatment with at least ...
What is the current status of trial NCT01271712?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 199 participants. The study started on 2011-01-04. Estimated completion is 2019-04-15.
What conditions does trial NCT01271712 study?
This clinical trial studies the following conditions: Gastrointestinal Stromal Tumors.
What interventions are being tested in trial NCT01271712?
The interventions under investigation include: Placebo (DRUG), Regorafenib (Stivarga, BAY73-4506) (DRUG), Best supportive care (DRUG).
Who is sponsoring clinical trial NCT01271712?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01271712 being conducted?
This trial has 20 study locations across Arizona, Illinois, Massachusetts, Minnesota, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01271712's enrollment target sits among peer trials
199 2nd of 10 the highest of 10 other Gastrointestinal Stromal Tumors trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Gastrointestinal Stromal Tumors 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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