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| Sponsor: | Taxolog Inc. |
|---|---|
| Information provided by: | Taxolog Inc. |
| ClinicalTrials.gov Identifier: | NCT00685204 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Mesothelioma |
Drug: Milataxel |
Phase II |
| Study Type: | Interventional |
| 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 |
| Estimated Enrollment: | 90 |
| Study Start Date: | March 2008 |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A
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.
|
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.
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Harvey Pass, M.D. | (212)731-5414 | harvey.pass@med.nyu.edu |
| United States, Illinois | |
| University of Chicago | Recruiting |
| Chicago, Illinois, United States, 60637 | |
| Contact: Sarah Mauro 773-834-3263 smauro@medicine.bsd.uchicago.edu | |
| Principal Investigator: Hedy Kindler, M.D. | |
| Rush University Medical Center | Not yet recruiting |
| Chicago, Illinois, United States, 60612 | |
| Contact: Philip Bonomi, M.D. 312-942-3192 philip_bonomi@rush.edu | |
| 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 harvey.pass@med.nyu.edu | |
| Principal Investigator: | Harvey Pass, M.D. | New York University Cancer Center |
More Information
| Responsible Party: | Harvey Pass, M.D. Chief, Division of Thoracic Surgery and Thoracic Oncology, New York University Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00685204 History of Changes |
| Other Study ID Numbers: | TL139204 |
| Study First Received: | May 21, 2008 |
| Last Updated: | May 22, 2008 |
| Health Authority: | United States: Food and Drug Administration |
|
Mesothelioma Adenoma Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Neoplasms Neoplasms, Mesothelial |