Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2025-12-28 @ 7:37 PM
Study NCT ID:
NCT00685204
Status:
UNKNOWN
Last Update Posted:
2008-05-28
First Post:
2008-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Efficacy Study of Milataxel (TL139) Administered Orally for Malignant Mesothelioma
Sponsor:
Taxolog Inc.
Organization:
Study Overview
Official Title:
A Phase II Study of Milataxel (TL139) Administered Orally in Patients With Malignant Mesothelioma
Status:
UNKNOWN
Status Verified Date:
2008-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TL139
Brief 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: