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

Genta Incorporated

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Advanced Melanoma

Interventions

Genasense® (G3139, oblimersen sodium)DRUG

Genasense followed by DTIC; then DTIC aloneDRUG

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

DTIC alone; then Genasense followed by DTICDRUG

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

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Data from ClinicalTrials.gov

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