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Tesetaxel as Second-line Therapy for Patients With Advanced Melanoma and Normal Serum LDH

NCT01092585 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2011-11-08

No results posted yet for this study

Summary

Tesetaxel is an orally administered chemotherapy agent of the taxane class. This study is being undertaken to evaluate the efficacy and safety of tesetaxel administered as second-line therapy to patients with advanced melanoma and normal serum lactate dehydrogenase (LDH).

Conditions

Interventions

DRUG

Tesetaxel

Tesetaxel capsules will be administered orally once every 21 days until the patient meets a withdrawal criterion or initiates nonstudy therapy for melanoma. The duration of protocol therapy will not exceed 12 months. In Cycle 1, a flat dose of 40 mg will be administered to patients of relatively normal weight. For patients who weigh at least 25% below their ideal body weight, a flat dose of 35 mg will be administered. For patients who weigh at least 25% above their ideal body weight, a flat dose of 45 mg will be administered. Dose escalation by 5 mg in Cycle 2 and an additional 5 mg in Cycle 3 is permitted provided protocol-specified criteria are met.

Sponsors & Collaborators

  • Genta Incorporated

    lead INDUSTRY

Principal Investigators

  • Agop Y Bedikian, MD · The University of Texas MD Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2012-03-31
Completion
2012-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01092585 on ClinicalTrials.gov