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

Phase 1

Completed

• Conditions: Advanced Melanoma
• Interventions: Drug: Genasense® (G3139, oblimersen sodium); Drug: DTIC alone; then Genasense followed by DTIC; Drug: Genasense followed by DTIC; then DTIC alone

• Registration Number: NCT00542893
• Lead Sponsor: Genta Incorporated

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04
• Study Completion: 2007-09
• Study First Submitted: 2007-10-10
• Study First Submitted QC: 2007-10-10
• Study First Posted: 2007-10-12
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-11
• Last Update Posted: 2012-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

• Metastatic Stage IV disease, or Stage III disease that is not surgically resectable
• ECOG Performance Status of 0, 1, or 2
• Life expectancy of at least 12 weeks
• Adequate venous access
• Agreement to practice effective method of birth control

Exclusion Criteria

• Less than 3 weeks of recovery from prior major surgery or other therapy, including radiation therapy, chemotherapy, or immunotherapy, or cytokine, biologic, or vaccine therapy
• Significant medical disease
• Known hypersensitivity to phosphorothioate-containing oligonucleotides
• Known hypersensitivity to DTIC
• Pregnancy/Lactation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group 1	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
Group 1	Genasense® (G3139, oblimersen sodium)	Cycle 1: DTIC 1000 mg/m2 Cycle 2: Genasense 7 mg/kg/day for 5 days followed by DTIC 1000 mg/m2
Group 2	Genasense® (G3139, oblimersen sodium)	Cycle 1: Genasense 7 mg/kg/day for 5 days followed by DTIC 1000 mg/m2 Cycle 2: DTIC 1000 mg/m2
Group 2	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