Back to results

An Efficacy Study of Milataxel (TL139) Administered Orally for Malignant Mesothelioma (TL139)

Primary Purpose

Mesothelioma

Status

Unknown status

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Milataxel

About this trial

This is an interventional treatment trial for Mesothelioma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Rush University Medical Center
University of ChicagoRecruiting
New York University Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

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.

Outcomes

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.

Full Information

NCT ID

NCT00685204

First Posted

May 21, 2008

Last Updated

May 22, 2008

Sponsor

Taxolog Inc.

1. Study Identification

Unique Protocol Identification Number

NCT00685204

Brief Title

An Efficacy Study of Milataxel (TL139) Administered Orally for Malignant Mesothelioma

Acronym

TL139

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2008

Overall Recruitment Status

Unknown status

Study Start Date

March 2008 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Taxolog Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mesothelioma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Allocation

N/A

Enrollment

90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Milataxel

Other Intervention Name(s)

TL139

Intervention Description

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 Information:

Title

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

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Harvey Pass, M.D.

Phone

(212)731-5414

harvey.pass@med.nyu.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Harvey Pass, M.D.

Organizational Affiliation

New York University Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rush University Medical Center

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60612

Country

United States

Individual Site Status

Not yet recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Philip Bonomi, M.D.

Phone

312-942-3192

philip_bonomi@rush.edu

Facility Name

University of Chicago

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60637

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sarah Mauro

Phone

773-834-3263

smauro@medicine.bsd.uchicago.edu

First Name & Middle Initial & Last Name & Degree

Hedy Kindler, M.D.

Facility Name

New York University Cancer Center

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Harvey Pass, M.D.

Phone

212-731-5414

harvey.pass@med.nyu.edu

12. IPD Sharing Statement

Learn more about this trial

An Efficacy Study of Milataxel (TL139) Administered Orally for Malignant Mesothelioma

We'll reach out to this number within 24 hrs