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Ph II Study of Perifosine Plus Gleevec for Patients With GIST

2014-07-23 21:29:50 | BioPortfolio

Summary

This is a Phase II trial designed to determine the efficacy and safety of perifosine plus imatinib mesylate in patients with advanced GIST who develop progressive disease or recurrence while receiving imatinib mesylate.

Description

This is a Phase II study of perifosine in combination with imatinib mesylate in patients with advanced GIST. Each cycle lasts 28 days. There will be two treatment arms. On both arms, patients will continue the dose of imatinib mesylate taken during the period of disease progression. Patients will be randomized to one either a weekly or a daily perifosine treatment regimen at the time of registration.

Study Design

Allocation: Randomized, Control: Historical Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Gastrointestinal Stromal Tumors

Intervention

Perifosine, Imatinib Mesylate

Status

Active, not recruiting

Source

Keryx / AOI Pharmaceuticals, Inc.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:29:50-0400

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Medical and Biotech [MESH] Definitions

A tyrosine kinase inhibitor and ANTINEOPLASTIC AGENT that inhibits the BCR-ABL kinase created by chromosome rearrangements in CHRONIC MYELOID LEUKEMIA and ACUTE LYMPHOBLASTIC LEUKEMIA, as well as PDG-derived tyrosine kinases that are overexpressed in gastrointestinal stromal tumors.

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Tumors or cancer of the GASTROINTESTINAL TRACT, from the MOUTH to the ANAL CANAL.

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