An Efficacy Study of Milataxel (TL139) Administered Orally for Malignant Mesothelioma
NCT ID: NCT00685204
Last Updated: 2008-05-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
90 participants
INTERVENTIONAL
2008-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
Study Groups
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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
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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Taxolog Inc.
INDUSTRY
Responsible Party
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New York University Cancer Center
Principal Investigators
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Harvey Pass, M.D.
Role: PRINCIPAL_INVESTIGATOR
New York University Cancer Center
Locations
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Rush University Medical Center
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
New York University Cancer Center
New York, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Philip Bonomi, M.D.
Role: primary
Sarah Mauro
Role: primary
Harvey Pass, M.D.
Role: primary
Other Identifiers
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TL139204
Identifier Type: -
Identifier Source: org_study_id