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

Genta Incorporated

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Advanced Melanoma and Normal or Impaired; Hepatic Function

Treatments: Drug: Genasense® (G3139, oblimersen sodium)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00543205

GPK103

Details and patient eligibility

About

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.

Enrollment: 6 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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