MedTrace Logo

Regorafenib in Patients With Metastatic and/or Unresectable Gastrointestinal Stromal Tumor

NCT01068769 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2020-08-24

Study results available
· View outcomes & findings →

Summary

The purpose of this research study is to determine the safety and activity of regorafenib in participants with advanced gastrointestinal stromal tumor (GIST) if the standard approved therapies, imatinib and sunitinib, have failed to control the disease. Regorafenib is a drug that blocks abnormally active signaling enzymes called "tyrosine kinases" which are important to the growth of GIST. This "tyrosine kinase inhibition" is similar to the way that both imatinib and sunitinib work; however, regorafenib blocks certain additional signaling pathways that are not blocked by imatinib or sunitinib. Regorafenib has been not been tested in GIST participants before this research study.

Conditions

  • Gastrointestinal Stromal Tumor

Interventions

DRUG

regorafenib

Taken orally, once a day in the morning for 3 weeks followed by a one week rest period

Sponsors & Collaborators

  • Brigham and Women's Hospital

    collaborator OTHER

  • Massachusetts General Hospital

    collaborator OTHER

  • Fox Chase Cancer Center

    collaborator OTHER

  • Oregon Health and Science University

    collaborator OTHER

  • Bayer

    collaborator INDUSTRY

  • Suzanne George, MD

    lead OTHER

Principal Investigators

  • Suzanne George, MD · Dana-Farber Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2012-06-30
Completion
2020-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01068769 on ClinicalTrials.gov