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

• Status: Terminated
• Trial end date: 2007-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genta Incorporated
• Treatments: Oblimersen

Criteria

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