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
  Purpose

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.


Condition Intervention Phase
Advanced Melanoma and Normal or Impaired
Hepatic Function
Drug: Genasense® (G3139, oblimersen sodium)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Genta Incorporated:

Primary Outcome Measures:
  • Pharmacokinetics of G3139 [ Time Frame: 6-day period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety [ Time Frame: 30 days post last dose of study medication ] [ Designated as safety issue: Yes ]

Enrollment: 6
Study Start Date: August 2005
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Genasense® (G3139, oblimersen sodium)
    Genasense 7 mg/kg/day for 5 days
    Other Names:
    • G3139
    • Oblimersen
    • Oblimersen sodium
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Genta Incorporated
ClinicalTrials.gov Identifier: NCT00543205     History of Changes
Other Study ID Numbers: GPK103
Study First Received: October 10, 2007
Last Updated: November 4, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on April 17, 2014