NCT00685204

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

A Phase II Study of Milataxel (TL139) Administered Orally in Patients With Malignant Mesothelioma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Taxolog Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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 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.

Conditions

• Mesothelioma

Interventions

Type	Name	Description
DRUG	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.

Timeline

• Start date: 2008-03-01
• First posted: 2008-05-28
• Last updated: 2008-05-28

Locations

3 sites across 1 country: United States