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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00543205
Recruitment Status : Terminated (Terminated due to very slow enrollment)
First Posted : October 12, 2007
Last Update Posted : November 7, 2011
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
Actual Primary Completion Date : May 2007
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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 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:
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Antineoplastic Agents