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

Phase 2

• Conditions: Melanoma

• Registration Number: NCT01092585
• Lead Sponsor: Genta Incorporated

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-03-23
• Study First Submitted QC: 2010-03-24
• Study First Posted: 2010-03-25
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-04
• Last Update Posted: 2011-11-08
• Primary Completion: 2012-03
• Study Completion: 2012-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Response rate (RECIST)	12 months from date of first dose of study medication

Secondary Outcome Measures

Name	Time	Method
Proportion of patients with a confirmed complete or partial response at least 3 months in duration	12 months from date of first dose of study medication
Disease control rate (ie, the proportion of patients with a confirmed complete or partial response of any duration or stable disease at least 3 months in duration)	12 months from date of first dose of study medication
Durable response rate (ie, the proportion of patients with a confirmed complete or partial response at least 6 months in duration)	12 months from date of first dose of study medication
Duration of response	12 months from date of first dose of study medication
Adverse events	Through 30 days post last dose of study medication

Trial Locations

Locations (1)

The University of Texas MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States