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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by Taxolog Inc..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Taxolog Inc.
ClinicalTrials.gov Identifier:
NCT00685204
First received: May 21, 2008
Last updated: May 22, 2008
Last verified: May 2008
  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 2

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

Resource links provided by NLM:


Further study details as provided by Taxolog Inc.:

Primary Outcome Measures:
  • To determine the objective response rate of milataxel when given orally to previously treated patients with malignant mesothelioma. [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To evaluate time to progression, duration of tumor response and safety and tolerability of TL139 treatment. [ Designated as safety issue: Yes ]

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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have histologically or cytologically confirmed malignant mesothelioma for which they have received pemetrexed in combination with cisplatin as part of chemotherapeutic regimen.
  • Prior cancer therapy with pemetrexed/cisplatin must have been completed at least 30 days prior to the first cycle of milataxel; prior radiotherapy (less than 25% of the bone marrow) must have been completed at least 30 days prior to study enrollment.
  • Patients must have measurable disease by the Modified RECIST criteria
  • Patients must have a life expectancy of at least 12 weeks and an ECOG performance status of 0, 1 or 2
  • Patients must be 18 years of age.
  • Patients must have adequate organ and system function.
  • Patients must be able to comply with the protocol treatments and procedures.
  • Patients with known brain metastases may be included in the study, providing they are clinically stable.
  • Recovered from all acute toxicities caused by prior cancer therapies, except for alopecia.

Exclusion Criteria:

  • Patients must not have received any other chemotherapeutic treatment for malignant mesothelioma other than pemetrexed and a platinum agent such as cisplatin.
  • Patients with grade 2 or greater peripheral neuropathy.
  • Prior cancer therapies not completed within 30 days prior to the first cycle of milataxel; radiotherapy completed less than 30 days prior to study enrollment; patients not recovered from radiation-related toxicities; patients receiving any concurrent anti-cancer therapy, including trastuzumab, bevacizumab or an investigational agent while on-study; patients with greater than 2 prior radiotherapy treatments.
  • Patients with known sensitivity to alcohol.
  • Patients with significant intercurrent illnesses.
  • Patients with symptomatic CNS metastases.
  • Patients who have had major surgery within the past 14 days.
  • Patients who require or are likely to require any strong modifier of CYP450 activity to be taken prior to milataxel administration
  • Patients who are receiving high dose steroids (more than a dexamethasone-equivalent dose of 4 mg per day).
  • Patients with malabsorption syndrome, disease significantly affecting gastrointestinal function, or major resection of the stomach or small bowel that could affect absorption of the study drug.
  • Women who are pregnant or breastfeeding.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00685204

Contacts
Contact: Harvey Pass, M.D. (212)731-5414 harvey.pass@med.nyu.edu

Locations
United States, Illinois
Rush University Medical Center Not yet recruiting
Chicago, Illinois, United States, 60612
Contact: Philip Bonomi, M.D.    312-942-3192    philip_bonomi@rush.edu   
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.         
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   
Sponsors and Collaborators
Taxolog Inc.
Investigators
Principal Investigator: Harvey Pass, M.D. New York University Cancer Center
  More Information

No publications provided

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

Additional relevant MeSH terms:
Lung Neoplasms
Mesothelioma
Neoplasms, Mesothelial
Adenoma
Lung Diseases
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms

ClinicalTrials.gov processed this record on October 23, 2014