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

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.