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

• 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.