NCT00542893

A Phase I, Randomized, Open-label, Cross-over, Pharmacokinetic Study of Genasense With and Without Dacarbazine

A Randomized, Open-label, Cross-over Pharmacokinetic Study of Dacarbazine in Combination With Genasense® in Subjects With Advanced Melanoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: —
• Sponsor: Genta Incorporated · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This clinical drug-drug interaction study is being conducted to evaluate the pharmacokinetics of dacarbazine(DTIC) when administered in combination with Genasense

Conditions

• Advanced Melanoma

Interventions

Type	Name	Description
DRUG	Genasense® (G3139, oblimersen sodium)
DRUG	Genasense followed by DTIC; then DTIC alone	Cycle 1: Genasense 7 mg/kg/day for 5 days followed by DTIC 1000 mg/m2 Cycle 2: DTIC 1000 mg/m2
DRUG	DTIC alone; then Genasense followed by DTIC	Cycle 1: DTIC 1000 mg/m2 Cycle 2: Genasense 7 mg/kg/day for 5 days followed by DTIC 1000 mg/m2

Timeline

• Start date: 2006-04-01
• Completion: 2007-09-01
• First posted: 2007-10-12
• Last updated: 2012-03-13