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A Phase I, Randomized, Open-label, Cross-over, Pharmacokinetic Study of Genasense With and Without Dacarbazine

Primary Purpose

Advanced Melanoma

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Genasense® (G3139, oblimersen sodium)
Genasense followed by DTIC; then DTIC alone
DTIC alone; then Genasense followed by DTIC
Sponsored by
Genta Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Melanoma focused on measuring bcl-2, CFR, DTIC, ECOG, EMEA, MedDRA, NCI CTC, SAE

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Metastatic Stage IV disease, or Stage III disease that is not surgically resectable
  • ECOG Performance Status of 0, 1, or 2
  • Life expectancy of at least 12 weeks
  • Adequate venous access
  • Agreement to practice effective method of birth control

Exclusion Criteria:

  • Less than 3 weeks of recovery from prior major surgery or other therapy, including radiation therapy, chemotherapy, or immunotherapy, or cytokine, biologic, or vaccine therapy
  • Significant medical disease
  • Known hypersensitivity to phosphorothioate-containing oligonucleotides
  • Known hypersensitivity to DTIC
  • Pregnancy/Lactation

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Group 1

    Group 2

    Arm Description

    Cycle 1: DTIC 1000 mg/m2 Cycle 2: Genasense 7 mg/kg/day for 5 days followed by DTIC 1000 mg/m2

    Cycle 1: Genasense 7 mg/kg/day for 5 days followed by DTIC 1000 mg/m2 Cycle 2: DTIC 1000 mg/m2

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    October 10, 2007
    Last Updated
    March 11, 2012
    Sponsor
    Genta Incorporated
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00542893
    Brief Title
    A Phase I, Randomized, Open-label, Cross-over, Pharmacokinetic Study of Genasense With and Without Dacarbazine
    Official Title
    A Randomized, Open-label, Cross-over Pharmacokinetic Study of Dacarbazine in Combination With Genasense® in Subjects With Advanced Melanoma
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    April 2006 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    September 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 clinical drug-drug interaction study is being conducted to evaluate the pharmacokinetics of dacarbazine(DTIC) when administered in combination with Genasense

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Advanced Melanoma
    Keywords
    bcl-2, CFR, DTIC, ECOG, EMEA, MedDRA, NCI CTC, SAE

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized

    8. Arms, Groups, and Interventions

    Arm Title
    Group 1
    Arm Type
    Experimental
    Arm Description
    Cycle 1: DTIC 1000 mg/m2 Cycle 2: Genasense 7 mg/kg/day for 5 days followed by DTIC 1000 mg/m2
    Arm Title
    Group 2
    Arm Type
    Experimental
    Arm Description
    Cycle 1: Genasense 7 mg/kg/day for 5 days followed by DTIC 1000 mg/m2 Cycle 2: DTIC 1000 mg/m2
    Intervention Type
    Drug
    Intervention Name(s)
    Genasense® (G3139, oblimersen sodium)
    Intervention Type
    Drug
    Intervention Name(s)
    Genasense followed by DTIC; then DTIC alone
    Intervention Description
    Cycle 1: Genasense 7 mg/kg/day for 5 days followed by DTIC 1000 mg/m2 Cycle 2: DTIC 1000 mg/m2
    Intervention Type
    Drug
    Intervention Name(s)
    DTIC alone; then Genasense followed by DTIC
    Intervention Description
    Cycle 1: DTIC 1000 mg/m2 Cycle 2: Genasense 7 mg/kg/day for 5 days followed by DTIC 1000 mg/m2

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Metastatic Stage IV disease, or Stage III disease that is not surgically resectable ECOG Performance Status of 0, 1, or 2 Life expectancy of at least 12 weeks Adequate venous access Agreement to practice effective method of birth control Exclusion Criteria: Less than 3 weeks of recovery from prior major surgery or other therapy, including radiation therapy, chemotherapy, or immunotherapy, or cytokine, biologic, or vaccine therapy Significant medical disease Known hypersensitivity to phosphorothioate-containing oligonucleotides Known hypersensitivity to DTIC Pregnancy/Lactation

    12. IPD Sharing Statement

    Learn more about this trial

    A Phase I, Randomized, Open-label, Cross-over, Pharmacokinetic Study of Genasense With and Without Dacarbazine

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