Last updated on May 2008

An Efficacy Study of Milataxel (TL139) Administered Orally for Malignant Mesothelioma


Brief description of study

Milataxel is a new taxane that may have several advantages over the currently available taxanes. The current study is designed to determine the response rate of oral Milataxel in patients with malignant Mesothelioma. The study specifically targets patients who have recurring or progressive disease following previous chemotherapy.

Detailed Study Description

This is a non-randomized, multicenter, open label, single agent phase II study. Patients with malignant mesothelioma that has recurred or progressed following chemotherapy, and who qualify for this study, will receive milataxel 60 mg/m2 orally on Day 1 of a 21 day cycle. If no toxicities of greater than Grade 1 severity occur, patients will receive 75 mg/m2 for the second and subsequent cycles. Patients will receive drug for a total of six cycles. Milataxel administration in excess of six cycles will be permitted at the discretion of the Investigator if patients have stable or responding disease.

Clinical Study Identifier: NCT00685204

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Philip Bonomi, M.D.

Rush University Medical Center
Chicago, IL United States
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Hedy Kindler, M.D.

University of Chicago
Chicago, IL United States
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Harvey Pass, M.D.

New York University Cancer Center
New York, NY United States
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