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

Hepatic Function Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00543205
• Other study ID #: GPK103
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: October 10, 2007
• Last updated: November 4, 2011
• Start date: August 2005
• Est. completion date: May 2007

Study information

• Verified date: March 2009
• Source: Genta Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: May 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Advanced Melanoma and Normal or Impaired
• Hepatic Function
• Melanoma

Intervention

Drug:
• Genasense® (G3139, oblimersen sodium)
Genasense 7 mg/kg/day for 5 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genta Incorporated

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics of G3139		6-day period	No
Secondary	Safety		30 days post last dose of study medication	Yes