NCT01151852

Rechallenge of Imatinib in GIST Having no Effective Treatment: RIGHT

A Prospective, Double Blind, Randomized, Placebo-Controlled Phase III Trial of Imatinib Re-Challenge in Patients With Gastrointestinal Stromal Tumor Who Had Benefit From Prior Imatinib But Progression From Both Imatinib and Sunitinib

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 81 (actual)
• Sponsor: Asan Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to compare the clinical outcomes following resumption of dosing (re-challenge) with Imatinib plus best supportive care versus placebo plus best supportive care in patients with advanced/incurable Gastrointestinal Stromal Tumors following failure of prior imatinib and sunitinib therapies.

Conditions

• Gastrointestinal Stromal Tumors

Interventions

Type	Name	Description
DRUG	Imatinib	Patients will be randomly assigned to receive imatinib at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression, unacceptable toxicity, or withdrawal of consent.
DRUG	Placebo	Patients will be randomly assigned to receive placebo at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression or withdrawal of consent.

Timeline

• Start date: 2010-06-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2010-06-29
• Last updated: 2020-01-14
• Results posted: 2015-07-28

Locations

1 site across 1 country: South Korea