NCT00543205

Pharmacokinetics of G3139 in Subjects With Advanced Melanoma, Including Those With Normal Hepatic Function and Those With Moderate Hepatic Impairment

A Pharmacokinetic Study of Genasense® (Bcl-2 Antisense Oligonucleotide) in Combination With Dacarbazine (DTIC) in Subjects With Advanced Melanoma and Normal or Impaired Hepatic Function

• Status: Terminated
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Genta Incorporated · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, parallel-group study with a total of 16 evaluable subjects. Subjects will be assigned to 1 of the following cohorts: Cohorts I (subjects with normal hepatic function; n+8 and Cohort II (subjects with moderate hepatic impairment, Child-Pugh classification Grade B; n=8). If, for any reason, the Genasense infusion is interrupted or discontinued prior to completion or the rate of administration of the Genasense infusion is changed, the subject will be replaced.

Conditions

• Advanced Melanoma and Normal or Impaired
• Hepatic Function

Interventions

Type	Name	Description
DRUG	Genasense® (G3139, oblimersen sodium)	Genasense 7 mg/kg/day for 5 days

Timeline

• Start date: 2005-08-01
• Primary completion: 2007-05-01
• Completion: 2007-05-01
• First posted: 2007-10-12
• Last updated: 2011-11-07