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

Status unconfirmed · Phase 2

Conditions studied: Mesothelioma

In brief

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.

Key facts

Study ID

NCT00685204

Run by

Taxolog Inc.

People needed

90

Starts

2008-03-01

Last updated by the study team

2008-05-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Chicago — Chicago, Illinois, United States (enrolling)
• New York University Cancer Center — New York, New York, United States (enrolling)
• Rush University Medical Center — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.