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

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ClinicalTrials.gov Identifier: NCT00724841
Recruitment Status : Terminated (Study terminated prematurely due to financial contraints.)
First Posted : July 30, 2008
Last Update Posted : July 22, 2016
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Gemin X )

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
Metastatic Melanoma Drug: Obatoclax Mesylate Drug: Temozolomide 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 Type : Interventional  (Clinical Trial)
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 : June 2008
Actual Primary Completion Date : July 2008
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma
U.S. FDA Resources

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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: GMX1777
Drug: Temozolomide



Primary Outcome Measures :
  1. Determine the recommended Phase II dose of GMX1777 in combination with temozolomide [ Time Frame: 2 years ]
  2. Learn more about the side effects of taking GMX1777 in combination with temozolomide [ Time Frame: Within the first 4 weeks ]
  3. Determine the disease response to treatment with GMX1777 in combination with temozolomide [ Time Frame: Within the first 8 weeks ]

Secondary Outcome Measures :
  1. Learn more about how the body processes GMX1777 [ Time Frame: Within the fisrt 30 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00724841


Locations
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
Gemin X
Investigators
Study Director: Mark Berger, MD Gemin X, Inc.

Responsible Party: Gemin X
ClinicalTrials.gov Identifier: NCT00724841     History of Changes
Other Study ID Numbers: GEM303
First Posted: July 30, 2008    Key Record Dates
Last Update Posted: July 22, 2016
Last Verified: July 2016

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
Temozolomide
Dacarbazine
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents