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

PHASE2UnknownINTERVENTIONAL
Enrollment

27

Participants

Timeline

Start Date

February 28, 2010

Primary Completion Date

March 31, 2012

Study Completion Date

March 31, 2012

Conditions
Melanoma
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."

Trial Locations (1)

77030

RECRUITING

The University of Texas MD Anderson Cancer Center, Houston

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Genta Incorporated

INDUSTRY