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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Study Completion Date

2007-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Advanced Melanoma and Normal or Impaired Hepatic Function

Study Design

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Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Genasense® (G3139, oblimersen sodium)

Genasense 7 mg/kg/day for 5 days

Intervention Type DRUG

Other Intervention Names

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G3139 Oblimersen Oblimersen sodium

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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GPK103

Identifier Type: -

Identifier Source: org_study_id