- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00685204
An Efficacy Study of Milataxel (TL139) Administered Orally for Malignant Mesothelioma (TL139)
May 22, 2008 updated by: Taxolog Inc.
A Phase II Study of Milataxel (TL139) Administered Orally in Patients With Malignant Mesothelioma
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 Overview
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 Type
Interventional
Enrollment (Anticipated)
90
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Harvey Pass, M.D.
- Phone Number: (212)731-5414
- Email: harvey.pass@med.nyu.edu
Study Locations
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Illinois
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Chicago, Illinois, United States, 60637
- Recruiting
- University of Chicago
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Contact:
- Sarah Mauro
- Phone Number: 773-834-3263
- Email: smauro@medicine.bsd.uchicago.edu
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Principal Investigator:
- Hedy Kindler, M.D.
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Chicago, Illinois, United States, 60612
- Not yet recruiting
- Rush University Medical Center
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Contact:
- Philip Bonomi, M.D.
- Phone Number: 312-942-3192
- Email: philip_bonomi@rush.edu
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New York
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New York, New York, United States, 10016
- Recruiting
- New York University Cancer Center
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Contact:
- Harvey Pass, M.D.
- Phone Number: 212-731-5414
- Email: harvey.pass@med.nyu.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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To determine the objective response rate of milataxel when given orally to previously treated patients with malignant mesothelioma.
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Secondary Outcome Measures
Outcome Measure |
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To evaluate time to progression, duration of tumor response and safety and tolerability of TL139 treatment.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Harvey Pass, M.D., New York University Cancer Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2008
Study Registration Dates
First Submitted
May 21, 2008
First Submitted That Met QC Criteria
May 22, 2008
First Posted (Estimate)
May 28, 2008
Study Record Updates
Last Update Posted (Estimate)
May 28, 2008
Last Update Submitted That Met QC Criteria
May 22, 2008
Last Verified
May 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TL139204
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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