A Phase II Study of Milataxel (TL139) Administered Orally in Patients With Malignant Mesothelioma
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.
Intervention Model: Single Group Assignment, Primary Purpose: Treatment
To determine the objective response rate of milataxel when given orally to previously treated patients with malignant mesothelioma.
Harvey Pass, M.D.
New York University Cancer Center
United States: Food and Drug Administration
|Rush University Medical Center||Chicago, Illinois 60612-3824|
|University of Chicago||Chicago, Illinois 60637|
|New York University Cancer Center||New York, New York 10016|