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

This study has been terminated.
(Terminated due to very slow enrollment)
Sponsor:
Information provided by (Responsible Party):
Genta Incorporated
ClinicalTrials.gov Identifier:
NCT00543205
First received: October 10, 2007
Last updated: November 4, 2011
Last verified: March 2009

October 10, 2007
November 4, 2011
August 2005
May 2007   (final data collection date for primary outcome measure)
Pharmacokinetics of G3139 [ Time Frame: 6-day period ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00543205 on ClinicalTrials.gov Archive Site
Safety [ Time Frame: 30 days post last dose of study medication ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
Not Provided
 
Pharmacokinetics of G3139 in Subjects With Advanced Melanoma, Including Those With Normal Hepatic Function and Those With Moderate Hepatic Impairment
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.

Not Provided
Interventional
Phase 2
Phase 3
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Advanced Melanoma and Normal or Impaired
  • Hepatic Function
Drug: Genasense® (G3139, oblimersen sodium)
Genasense 7 mg/kg/day for 5 days
Other Names:
  • G3139
  • Oblimersen
  • Oblimersen sodium
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
6
May 2007
May 2007   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00543205
GPK103
No
Genta Incorporated
Genta Incorporated
Not Provided
Not Provided
Genta Incorporated
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP