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Study Evaluating IPI-504 in Patients With Gastrointestinal Stromal Tumors (GIST) Following Failure of at Least Imatinib and Sunitinib

ABSTRACT: IPI-504-06 is a Phase 3, randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy and safety of IPI-504 as compared to placebo in patients with metastatic and/or unresectable GIST following failure of at least imatinib and sunitinib. Approximately 195 patients will be randomized using a 2:1 ratio to receive either IPI-504 (N=130) or placebo (N=65). Upon unblinding, patients receiving either IPI-504 or placebo may receive IPI-504 in the open-label portion of the study if defined inclusion criteria are met. Early and frequent imaging timepoints (Weeks 2, 5, 8, 14 and every 6 weeks thereafter) are incorporated into this study to capture progression events and limit patient exposure to ineffective agents.

DISEASE(S): Metastatic And/or Unresectable Gastro-intestinal Stromal Tumors In Patients Following Failure Of Treatment With At Least Imatinib And Sunitinib.,Gastrointestinal Stromal Tumor,Gastrointestinal Stromal Tumors

PROVIDER: 2056213 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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