An Efficacy Study of Milataxel (TL139) Administered Orally for Malignant Mesothelioma
Recruitment status was Recruiting
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.
|Study Design:||Intervention Model: Single Group Assignment
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Milataxel (TL139) Administered Orally in Patients With Malignant Mesothelioma|
- To determine the objective response rate of milataxel when given orally to previously treated patients with malignant mesothelioma. [ Designated as safety issue: Yes ]
- To evaluate time to progression, duration of tumor response and safety and tolerability of TL139 treatment. [ Designated as safety issue: Yes ]
|Study Start Date:||March 2008|
This is a non-random, multicenter, open label, single agent study. Patients with mailgnanat mesothelioma that has reccured or progressed following chemotherapy, and who qualify for this study, will receive oral milataxel.
Milataxel is a liquid that is dosed orally at 60 mg/m2 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.
Other Name: TL139
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00685204
|Contact: Harvey Pass, M.D.||(212)firstname.lastname@example.org|
|United States, Illinois|
|Rush University Medical Center||Not yet recruiting|
|Chicago, Illinois, United States, 60612|
|Contact: Philip Bonomi, M.D. 312-942-3192 email@example.com|
|University of Chicago||Recruiting|
|Chicago, Illinois, United States, 60637|
|Contact: Sarah Mauro 773-834-3263 firstname.lastname@example.org|
|Principal Investigator: Hedy Kindler, M.D.|
|United States, New York|
|New York University Cancer Center||Recruiting|
|New York, New York, United States, 10016|
|Contact: Harvey Pass, M.D. 212-731-5414 email@example.com|
|Principal Investigator:||Harvey Pass, M.D.||New York University Cancer Center|