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

NCT00543205 | Terminated Phase 2

• 1 other identifier: GPK103
• Study Type: interventional
• Target: 6
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Advanced Melanoma and Normal or Impaired; Hepatic Function

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetics of G3139

  6-day period

Secondary Outcomes (1)

• Safety

  30 days post last dose of study medication

Interventions

Genasense® (G3139, oblimersen sodium) DRUG

Genasense 7 mg/kg/day for 5 days

Also known as: G3139, Oblimersen, Oblimersen sodium

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Genta Incorporated: lead

MeSH Terms

Interventions

oblimersen

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2007
• First Posted: October 12, 2007
• Study Start: August 1, 2005
• Primary Completion: May 1, 2007
• Study Completion: May 1, 2007
• Last Updated: November 7, 2011

Record last verified: 2009-03