Pharmacokinetics of G3139 in Subjects With Advanced Melanoma, Including Those With Normal Hepatic Function and Those With Moderate Hepatic Impairment

Phase 3TerminatedNCT00543205

Genta Incorporated6 enrolled

Overview

This is an open-label, parallel-group study with a total of 16 evaluable subjects. Subjects will be assigned to 1 of the following cohorts: Cohorts I (subjects with normal hepatic function; n+8 and Cohort II (subjects with moderate hepatic impairment, Child-Pugh classification Grade B; n=8). If, for any reason, the Genasense infusion is interrupted or discontinued prior to completion or the rate of administration of the Genasense infusion is changed, the subject will be replaced.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Advanced Melanoma and Normal or Impaired Hepatic Function

Interventions

Genasense® (G3139, oblimersen sodium)

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Histologically confirmed diagnosis of malignant melanoma * Metastatic Stage IV disease, or Stage III disease that is not surgically resectable * ECOG Performance status of 0,1,or 2 * Adequate venous access * Agreement to practice effective methods of birth control * Hepatically impaired consistent with Child-Pugh classification Grade B Exclusion Criteria: * Chronic intravascular coagulopathy confirmed by the presence of fibrinogen degradation products, metastases to the liver, or exudative ascites * Prior organ allograft * Requirement for concomitant anticoagulant therapy (with the exception of 1 mg/day of warfarin for central line prophylaxis) while receiving protocol therapy * Known hypersensitive to DTIC * Prior treatment with Genasense

Outcomes

Primary Outcomes

Pharmacokinetics of G3139

Time frame: 6-day period

Secondary Outcomes

Safety

Time frame: 30 days post last dose of study medication