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

PHASE1CompletedINTERVENTIONAL

Timeline

Start Date

April 30, 2006

Study Completion Date

September 30, 2007

Conditions

Advanced Melanoma

Interventions

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