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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 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.

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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.

Conditions Studied

Gastrointestinal Stromal Tumors

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

FieldValue
Enrollment Target 199 participants
Start Date 2011-01-04
Est. Completion 2019-04-15
Phase Phase 3

Sponsor

Bayer

591 total trials

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What the Registry Record Tells You About NCT01271712

The ClinicalTrials.gov registry entry for NCT01271712 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 199 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 75-participant average among 10 other Gastrointestinal Stromal Tumors trials with a reported enrollment target (165% higher). The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 14 distinct geographic areas - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.