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

Genta Incorporated

Status and phase: Completed; Phase 1

Conditions: Advanced Melanoma

Treatments: Drug: Genasense® (G3139, oblimersen sodium); Drug: Genasense followed by DTIC; then DTIC alone; Drug: DTIC alone; then Genasense followed by DTIC

Study type: Interventional

Funder types: Industry

Identifiers

NCT00542893

GPK105

Details and patient eligibility

About

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

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Group 1

Experimental group

Description:

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

Treatment:

Drug: Genasense® (G3139, oblimersen sodium)

Drug: DTIC alone; then Genasense followed by DTIC

Group 2

Experimental group

Description:

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

Treatment:

Drug: Genasense® (G3139, oblimersen sodium)

Drug: Genasense followed by DTIC; then DTIC alone