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

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ClinicalTrials.gov Identifier: NCT00543205
Recruitment Status : Terminated (Terminated due to very slow enrollment)
First Posted : October 12, 2007
Last Update Posted : November 7, 2011
Sponsor:
Information provided by (Responsible Party):
Genta Incorporated

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.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : August 2005
Primary Completion Date : May 2007
Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
U.S. FDA Resources


Intervention Details:
    Drug: Genasense® (G3139, oblimersen sodium)
    Genasense 7 mg/kg/day for 5 days
    Other Names:
    • G3139
    • Oblimersen
    • Oblimersen sodium


Primary Outcome Measures :
  1. Pharmacokinetics of G3139 [ Time Frame: 6-day period ]

Secondary Outcome Measures :
  1. Safety [ Time Frame: 30 days post last dose of study medication ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

Responsible Party: Genta Incorporated
ClinicalTrials.gov Identifier: NCT00543205     History of Changes
Other Study ID Numbers: GPK103
First Posted: October 12, 2007    Key Record Dates
Last Update Posted: November 7, 2011
Last Verified: March 2009

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
Oblimersen
Antineoplastic Agents