MesotheliomaPhase 2TL139NCT00685204
An Efficacy Study of Milataxel (TL139) Administered Orally for Malignant Mesothelioma
A Phase 2 study testing Milataxel in people with Mesothelioma, run by Taxolog Inc. at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mesothelioma
- What is being tested?
- Milataxel
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2008to not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 3 recruiting
- Not yet recruiting
Rush University Medical Center
Chicago, Illinois, 60612
Philip Bonomi, M.D., 312-942-3192, philip_bonomi@rush.edu
- Recruiting
University of Chicago
Chicago, Illinois, 60637
Sarah Mauro, 773-834-3263, smauro@medicine.bsd.uchicago.edu
Hedy Kindler, M.D.
- Recruiting
New York University Cancer Center
New York, New York, 10016
Harvey Pass, M.D., 212-731-5414, harvey.pass@med.nyu.edu
About this study
Official title: A Phase II Study of Milataxel (TL139) Administered Orally in Patients With Malignant Mesothelioma
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.
Read the detailed description
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.
- Conditions
- Mesothelioma
- Being tested
- Milataxel
- Medical subject headings
- Mesothelioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MilataxelDrug
Also called TL139
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Milataxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2008 (estimated)
- Study startMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MesotheliomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taxolog Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Harvey Pass, M.D., Principal investigator, New York University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00685204
- Sponsor's protocol ID
- TL139204
- Acronym
- TL139
- Status last verified
- May 2008
- First submitted
- 21 May 2008
- Last updated
- 28 May 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Milataxel (TL139) Administered Orally in Patients With Malignant Mesothelioma
- ClinicalTrials.gov ID
- NCT00685204
- Acronym / sponsor ID
- TL139 / TL139204
- Conditions
- Mesothelioma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Taxolog Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2008
- First posted
- 28 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: MilataxelThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MilataxelAlso: TL139Milataxel 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. | Drug | A |
Primary outcome
To determine the objective response rate of milataxel when given orally to previously treated patients with malignant mesothelioma.
1 secondary outcome
To evaluate time to progression, duration of tumor response and safety and tolerability of TL139 treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Harvey Pass, M.D. principal investigator
New York University Cancer Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Milataxel in people with Mesothelioma, run by Taxolog Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Harvey Pass, M.D. ((212)731-5414, harvey.pass@med.nyu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the objective response rate of milataxel when given orally to previously treated patients with malignant mesothelioma.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2008; AzTrials last refreshed its copy on 6 Nov 2026.