NCT00685204

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 28, 2008

Completed
Last Updated

May 28, 2008

Status Verified

May 1, 2008

First QC Date

May 21, 2008

Last Update Submit

May 22, 2008

Conditions

Mesothelioma

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

  • To evaluate time to progression, duration of tumor response and safety and tolerability of TL139 treatment.

Study Arms (1)

A

EXPERIMENTAL

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.

Drug: Milataxel

Interventions

MilataxelDRUG

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.

Also known as: TL139
A

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Rush University Medical Center

Chicago, Illinois, 60612, United States

NOT YET RECRUITING

University of Chicago

Chicago, Illinois, 60637, United States

RECRUITING

New York University Cancer Center

New York, New York, 10016, United States

RECRUITING

MeSH Terms

Conditions

Mesothelioma

Interventions

MAC321

Condition Hierarchy (Ancestors)

AdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsNeoplasms, Mesothelial

Study Officials

  • Harvey Pass, M.D.

    New York University Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Harvey Pass, M.D.

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 21, 2008

First Posted

May 28, 2008

Study Start

March 1, 2008

Last Updated

May 28, 2008

Record last verified: 2008-05

Locations

US(3)