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Spots Global Cancer Trial Database for An Efficacy Study of Milataxel (TL139) Administered Orally for Malignant Mesothelioma

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Trial Identification

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

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

Study ID: NCT00685204

Conditions

Mesothelioma

Interventions

Milataxel

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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Rush University Medical Center, Chicago, Illinois, United States

University of Chicago, Chicago, Illinois, United States

New York University Cancer Center, New York, New York, United States

Contact Details

Name: Harvey Pass, M.D.

Affiliation: New York University Cancer Center

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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