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

This study has been terminated.
(Study terminated prematurely due to financial contraints.)
Sponsor:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Gemin X )
ClinicalTrials.gov Identifier:
NCT00724841
First received: July 28, 2008
Last updated: August 28, 2013
Last verified: August 2013
  Purpose

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 Intervention Phase
Metastatic Melanoma
Drug: GMX1777
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • Determine the recommended Phase II dose of GMX1777 in combination with temozolomide [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Learn more about the side effects of taking GMX1777 in combination with temozolomide [ Time Frame: Within the first 4 weeks ] [ Designated as safety issue: Yes ]
  • Determine the disease response to treatment with GMX1777 in combination with temozolomide [ Time Frame: Within the first 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Learn more about how the body processes GMX1777 [ Time Frame: Within the fisrt 30 days ] [ Designated as safety issue: No ]

Enrollment: 1
Study Start Date: June 2008
Study Completion Date: August 2010
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
40 mg/m2 GMX1777
Drug: GMX1777
GMX1777 at various doses in combination with temozolomide
Experimental: 2
50 mg/m2 GMX1777
Drug: GMX1777
GMX1777 at various doses in combination with temozolomide
Experimental: 3
62 mg/m2 GMX1777
Drug: GMX1777
GMX1777 at various doses in combination with temozolomide
Experimental: 4
80 mg/m2 GMX1777
Drug: GMX1777
GMX1777 at various doses in combination with temozolomide
Experimental: 5
100 mg/m2 GMX1777
Drug: GMX1777
GMX1777 at various doses in combination with temozolomide
Experimental: 6
125 mg/m2 GMX1777
Drug: GMX1777
GMX1777 at various doses in combination with temozolomide

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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.
  More Information

No publications provided

Responsible Party: Teva Pharmaceutical Industries ( Gemin X )
ClinicalTrials.gov Identifier: NCT00724841     History of Changes
Other Study ID Numbers: GEM303
Study First Received: July 28, 2008
Last Updated: August 28, 2013
Health Authority: United States: Food and Drug Administration

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
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 20, 2014