search
Back to results

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

Primary Purpose

Advanced Melanoma and Normal or Impaired, Hepatic Function

Status
Terminated
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Genasense® (G3139, oblimersen sodium)
Sponsored by
Genta Incorporated
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Melanoma and Normal or Impaired

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Pharmacokinetics of G3139

    Secondary Outcome Measures

    Safety

    Full Information

    First Posted
    October 10, 2007
    Last Updated
    November 4, 2011
    Sponsor
    Genta Incorporated
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00543205
    Brief Title
    Pharmacokinetics of G3139 in Subjects With Advanced Melanoma, Including Those With Normal Hepatic Function and Those With Moderate Hepatic Impairment
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2009
    Overall Recruitment Status
    Terminated
    Why Stopped
    Terminated due to very slow enrollment
    Study Start Date
    August 2005 (undefined)
    Primary Completion Date
    May 2007 (Actual)
    Study Completion Date
    May 2007 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Genta Incorporated

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Advanced Melanoma and Normal or Impaired, Hepatic Function

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Enrollment
    6 (Actual)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Genasense® (G3139, oblimersen sodium)
    Other Intervention Name(s)
    G3139, Oblimersen, Oblimersen sodium
    Intervention Description
    Genasense 7 mg/kg/day for 5 days
    Primary Outcome Measure Information:
    Title
    Pharmacokinetics of G3139
    Time Frame
    6-day period
    Secondary Outcome Measure Information:
    Title
    Safety
    Time Frame
    30 days post last dose of study medication

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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

    12. IPD Sharing Statement

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs