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

NCT ID: NCT00542893

Last Updated: 2012-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30
• Study Completion Date: 2007-09-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1

Cycle 1: DTIC 1000 mg/m2 Cycle 2: Genasense 7 mg/kg/day for 5 days followed by DTIC 1000 mg/m2

Group Type: EXPERIMENTAL

Genasense® (G3139, oblimersen sodium)

Intervention Type: DRUG

DTIC alone; then Genasense followed by DTIC

Intervention Type: DRUG

Cycle 1: DTIC 1000 mg/m2 Cycle 2: Genasense 7 mg/kg/day for 5 days followed by DTIC 1000 mg/m2

Group 2

Cycle 1: Genasense 7 mg/kg/day for 5 days followed by DTIC 1000 mg/m2 Cycle 2: DTIC 1000 mg/m2

Group Type: EXPERIMENTAL

Genasense® (G3139, oblimersen sodium)

Intervention Type: DRUG

Genasense followed by DTIC; then DTIC alone

Intervention Type: DRUG

Cycle 1: Genasense 7 mg/kg/day for 5 days followed by DTIC 1000 mg/m2 Cycle 2: DTIC 1000 mg/m2

Interventions

Genasense® (G3139, oblimersen sodium)

Intervention Type: 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

Intervention Type: 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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Genta Incorporated

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

GPK105

Identifier Type: -

Identifier Source: org_study_id