• To determine the objective response rate of milataxel when given orally to previously treated patients with malignant mesothelioma. [ Designated as safety issue: Yes ]
  

• To evaluate time to progression, duration of tumor response and safety and tolerability of TL139 treatment. [ Designated as safety issue: Yes ]
  

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.

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.