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

November 4, 2011 updated by: Genta Incorporated

A Pharmacokinetic Study of Genasense® (Bcl-2 Antisense Oligonucleotide) in Combination With Dacarbazine (DTIC) in Subjects With Advanced Melanoma and Normal or Impaired Hepatic Function

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Drug: Genasense® (G3139, oblimersen sodium)

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 2
Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Interventional Model: Parallel Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetics of G3139 Time Frame: 6-day period	6-day period

Secondary Outcome Measures

Outcome Measure	Time Frame
Safety Time Frame: 30 days post last dose of study medication	30 days post last dose of study medication

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genta Incorporated

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2005

Primary Completion (Actual)

May 1, 2007

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

October 10, 2007

First Submitted That Met QC Criteria