CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 34 enrolled
Drug / intervention
regorafenibdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01068769
NCT01068769Phase 2Completed

A Multi-center Phase II Study Evaluating the Efficacy and Safety of Regorafenib in Patients With Metastatic and/or Unresectable Gastrointestinal Stromal Tumor (GIST), Resistent or Intolerant to at Least Imatinib and Sunitinib

Suzanne George, MD·interventional·Posted Feb 15, 2010·Updated Aug 24, 2020

In Brief

A Phase 2 clinical trial evaluating regorafenib for Gastrointestinal Stromal Tumor. Completed, enrolled 34 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 15, 2010
Enrollment StartFeb 1, 2010
Primary CompletionJun 1, 2012
Study CompletionAug 1, 2020
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 16.4 years ago

Interventions

regorafenibdrug

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