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Taxane

Oral Milataxel for Mesothelioma (TL139 Trial)

Phase 2
Waitlist Available
Led By Harvey Pass, M.D.
Research Sponsored by Taxolog Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must have adequate organ and system function.
Patients must have histologically or cytologically confirmed malignant mesothelioma for which they have received pemetrexed in combination with cisplatin as part of chemotherapeutic regimen.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

TL139 Trial Summary

This trial is looking at a new chemotherapy drug for people with mesothelioma who haven't responded to other treatments.

Who is the study for?
This trial is for adults with malignant mesothelioma who've had pemetrexed and cisplatin chemotherapy but are now facing disease progression. They should have good organ function, be stable if they have brain metastases, and not suffer from severe neuropathy or conditions affecting drug absorption.Check my eligibility
What is being tested?
The study tests Milataxel (TL139), an oral medication potentially better than existing taxanes, to see its effectiveness in treating Mesothelioma patients whose cancer has returned or worsened after initial chemo treatment.See study design
What are the potential side effects?
While specific side effects of Milataxel aren't listed here, common ones for taxane drugs include low blood cell counts leading to infection risk, hair loss, nerve damage causing numbness or pain in hands/feet, muscle aches, and nausea.

TL139 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My organs are functioning well.
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I have mesothelioma and was treated with pemetrexed and cisplatin.
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I have brain metastases but am currently stable.
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I have recovered from side effects of previous cancer treatments, except for hair loss.
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I am expected to live at least 12 weeks and can care for myself.
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I finished treatments with pemetrexed/cisplatin and any radiotherapy affecting less than 25% of my bone marrow over 30 days ago.
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I am 18 years old or older.

TL139 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To determine the objective response rate of milataxel when given orally to previously treated patients with malignant mesothelioma.
Secondary outcome measures
To evaluate time to progression, duration of tumor response and safety and tolerability of TL139 treatment.

TL139 Trial Design

1Treatment groups
Experimental Treatment
Group I: AExperimental Treatment1 Intervention
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.

Find a Location

Who is running the clinical trial?

Taxolog Inc.Lead Sponsor
Harvey Pass, M.D.Principal InvestigatorNew York University Cancer Center

Media Library

Milataxel (Taxane) Clinical Trial Eligibility Overview. Trial Name: NCT00685204 — Phase 2
Mesothelioma Research Study Groups: A
Mesothelioma Clinical Trial 2023: Milataxel Highlights & Side Effects. Trial Name: NCT00685204 — Phase 2
Milataxel (Taxane) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00685204 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has a research program like this ever been done before?

"Presently, only one Milataxel trial is live in 2 cities across 1 nation. Taxolog Inc.'s clinical trial from 2008 was the first to explore this medicine's efficacy; it necessitated 90 participants and concluded its Phase 2 regulatory process. Since then, no new studies have been conducted."

Answered by AI

Has the FDA sanctioned Milataxel as an acceptable treatment?

"Milataxel's safety was assessed with a score of 2 since there is evidence to support its security, yet no research has been conducted regarding the drug's efficacy."

Answered by AI

What prior investigations have been conducted with regards to Milataxel?

"Currently, only one clinical trial is actively testing Milataxel. This medical study has not yet reached Phase 3 of the process and is mainly conducted in New york City with three other sites involved."

Answered by AI

Are there any vacancies available in this research project?

"As per the information posted on clinicaltrials.gov, this study is not presently accepting patients. This trial was originally published in March 2008 and last edited in May of that same year. Although no new participants can join this specific research project at present, there are 153 other trials actively recruiting right now."

Answered by AI

How many participants can this clinical trial accommodate?

"At the moment, applications for this trial are not being accepted. Initially posted on March 1st 2008 and most recently updated May 22nd of the same year; if you're looking to participate in other studies, there is a range of 152 mesothelioma trials and one Milataxel research project actively recruiting patients."

Answered by AI
~5 spots leftby Mar 2025