Trial intelligence / Profile preview

RING: IPI-504 in GIST

NCT00688766Phase 3

Key facts

Status: Terminated
Start: Aug 2008
Primary completion: May 2009
Sponsor: Infinity Pharmaceuticals, Inc.
Modality: Small Molecules

Drugs: retaspimycin
Conditions: gastrointestinal stromal tumor (GIST)

Overview

Phase 3, randomised, double-blind trial in gastrointestinal stromal tumor (GIST) comparing IPI-504 with Placebo (2 arms). Primary endpoint: Progression Free Survival. Started Aug 2008; status: terminated.

Design

2 arms

Study design: RandomizedDouble-blind

IPI-504
retaspimycin hydrochloride (IPI-504) + Best supportive care
Placebo
Placebo + Best supportive care

Endpoints

Primary

Progression Free SurvivalMultiple timepoints

Secondary

Disease Control RateMultiple timepoints
Time to ProgressionMultiple timepoints
Overall SurvivalContinuous
Safety and TolerabilitySigning of informed consent to 30 days after discontinuation

Results

Not all primary endpoints met

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