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A Phase II Study of Milataxel (TL139) Administered Orally in Patients With Malignant Mesothelioma

Phase 2
18 Years
Open (Enrolling)

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Trial Information

A Phase II Study of Milataxel (TL139) Administered Orally in Patients With Malignant Mesothelioma

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

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

- 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.

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Primary Purpose: Treatment

Outcome Measure:

To determine the objective response rate of milataxel when given orally to previously treated patients with malignant mesothelioma.

Safety Issue:


Principal Investigator

Harvey Pass, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

New York University Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

March 2008

Completion Date:

Related Keywords:

  • Mesothelioma
  • Mesothelioma



Rush University Medical Center Chicago, Illinois  60612-3824
University of Chicago Chicago, Illinois  60637
New York University Cancer Center New York, New York  10016