Recruiting
Phase 2

Milataxel

Sponsor:

Taxolog Inc.

Code:

NCT00685204

Conditions

Mesothelioma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Milataxel

Study Details

Brief summary:

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.

Conditions

Mesothelioma

Study ID

NCT00685204

Start date

Mar, 2008

Status verified date

May, 2008

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

90 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: A

This is a non-random, multicenter, open label, single agent study. Patients with mailgnanat mesothelioma that has reccured or progressed following chemotherapy, and who qualify for this study, will receive oral milataxel.

Interventions

Milataxel

Milataxel is a liquid that is dosed orally at 60 mg/m2 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.

Primary outcome measure

  • To determine the objective response rate of milataxel when given orally to previously treated patients with malignant mesothelioma. [ Time Frame: undefined ]

Central Contacts and Locations

Central contacts

Harvey Pass, M.D.

(212)731-5414harvey.pass@med.nyu.edu

Locations

University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Sarah Mauro

773-834-3263smauro@medicine.bsd.uchicago.edu

Principal Investigator:

Hedy Kindler, M.D.

New York University Cancer Center

Recruiting

New York, New York, United States, 10016

Contacts

Harvey Pass, M.D.

212-731-5414harvey.pass@med.nyu.edu

More Information

Sponsor

Taxolog Inc.

Last update posted

May 28, 2008

Last verified

May, 2008

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Taxolog Inc. on 2008-05-28.