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A Phase I/II Study of GMX1777 in Combination With Temozolomide for the Treatment of Metastatic Melanoma

Sponsor
Gemin X (Industry)
Overall Status
Terminated
CT.gov ID
NCT00724841
Collaborator
(none)
1
Enrollment
1
Location
6
Arms
26
Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Obatoclax Mesylate (GMX1777) is a water-soluble, intravenously-administered pro-drug of GMX1778. GMX1777 is rapidly converted to GMX1778 in vivo. GMX1778 has potent anti-tumor activity against a variety of cell lines and models from different tumor origins.

Condition or Disease Intervention/Treatment Phase
Phase 1/Phase 2

Detailed Description

GMX1777 will be administered as 3-Hour Infusions in Combination with Temozolomide taken orally for the treatment of Metastatic Melanoma. GMX1777 infusion will be given on either day 1, days 1 and 3, or days 1,3, and 5 every 4 weeks. Temozolomide will be administered on 5 consecutive days every 4 weeks. No investigational or commercial agents or therapies other than those described may be administered with the intent to treat the patient's malignancy.

Study Design

Study Type:
Interventional
Actual Enrollment :
1 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Multi-Center, Open-Label, Phase I/II Study of GEM1777 in Combination With Temozolomide Administered Every 4 Weeks to Patients With Metastatic Melanoma
Study Start Date :
Jun 1, 2008
Actual Primary Completion Date :
Jul 1, 2008
Actual Study Completion Date :
Aug 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Experimental: 1

40 mg/m2 GMX1777 with Temozolomide

Drug: Obatoclax Mesylate
Obatoclax Mesylate (GMX1777) at various doses in combination with temozolomide
Other Names:
  • GMX1777

    • Drug: Temozolomide
    Experimental: 2

    50 mg/m2 GMX1777 with Temozolomide

    Drug: Obatoclax Mesylate
    Obatoclax Mesylate (GMX1777) at various doses in combination with temozolomide
    Other Names:
  • GMX1777

    • Drug: Temozolomide
    Experimental: 3

    62 mg/m2 GMX1777 with Temozolomide

    Drug: Obatoclax Mesylate
    Obatoclax Mesylate (GMX1777) at various doses in combination with temozolomide
    Other Names:
  • GMX1777

    • Drug: Temozolomide
    Experimental: 4

    80 mg/m2 GMX1777 with Temozolomide

    Drug: Obatoclax Mesylate
    Obatoclax Mesylate (GMX1777) at various doses in combination with temozolomide
    Other Names:
  • GMX1777

    • Drug: Temozolomide
    Experimental: 5

    100 mg/m2 GMX1777 with Temozolomide

    Drug: Obatoclax Mesylate
    Obatoclax Mesylate (GMX1777) at various doses in combination with temozolomide
    Other Names:
  • GMX1777

    • Drug: Temozolomide
    Experimental: 6

    125 mg/m2 GMX1777 with Temozolomide

    Drug: Obatoclax Mesylate
    Obatoclax Mesylate (GMX1777) at various doses in combination with temozolomide
    Other Names:
  • GMX1777

    • Drug: Temozolomide

    Outcome Measures

    Primary Outcome Measures

    1. Determine the recommended Phase II dose of GMX1777 in combination with temozolomide [2 years]

    2. Learn more about the side effects of taking GMX1777 in combination with temozolomide [Within the first 4 weeks]

    3. Determine the disease response to treatment with GMX1777 in combination with temozolomide [Within the first 8 weeks]

    Secondary Outcome Measures

    1. Learn more about how the body processes GMX1777 [Within the fisrt 30 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Histologically or cytologically confirmed metastatic melanoma

    • Up to 1 prior chemotherapy regimen allowed; prior immunotherapy allowed

    • Normal organ and marrow function

    • Willing to submit to blood sampling for planned PK/PD analyses

    • Ability of understand and willingness to sign a written informed consent

    Exclusion Criteria:

    • No other investigational or commercial agents or therapies

    • Prior exposure to GMX1777, GMX1778 or CHS828

    • Patients with uncontrolled, intercurrent illness

    • Pregnant or breastfeeding women

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Pennsylvania Philadelphia Pennsylvania United States 19104

    Sponsors and Collaborators

    • Gemin X

    Investigators

    • Study Director: Mark Berger, MD, Gemin X, Inc.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gemin X
    ClinicalTrials.gov Identifier:
    NCT00724841
    Other Study ID Numbers:
    • GEM303
    First Posted:
    Jul 30, 2008
    Last Update Posted:
    Jul 22, 2016
    Last Verified:
    Jul 1, 2016
    Additional relevant MeSH terms:
    Melanoma
    Temozolomide
    Obatoclax

    Study Results

    No Results Posted as of Jul 22, 2016