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.
Interventional
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.
Yes
Harvey Pass, M.D.
Principal Investigator
New York University Cancer Center
United States: Food and Drug Administration
TL139204
NCT00685204
March 2008
Name | Location |
---|---|
Rush University Medical Center | Chicago, Illinois 60612-3824 |
University of Chicago | Chicago, Illinois 60637 |
New York University Cancer Center | New York, New York 10016 |