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Safety and Efficacy of GMX1777 in the Treatment of Refractory Solid Tumors or Lymphomas

This study has been withdrawn prior to enrollment.
(Study terminated prematurely due to financial constraints.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00457574
First Posted: April 6, 2007
Last Update Posted: August 28, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Gemin X )
April 5, 2007
April 6, 2007
August 28, 2013
March 2007
July 2009   (Final data collection date for primary outcome measure)
Determine the recommended Phase II dose; Characterize the dose-limiting toxicities; Determine the pharmacokinetic parameters [ Time Frame: 52 weeks ]
Determine the recommended Phase II dose; Characterize the dose-limiting toxicities; Determine the pharmacokinetic parameters
Complete list of historical versions of study NCT00457574 on ClinicalTrials.gov Archive Site
Describe observed tumor responses [ Time Frame: 52 weeks ]
Describe observed tumor responses
Not Provided
Not Provided
 
Safety and Efficacy of GMX1777 in the Treatment of Refractory Solid Tumors or Lymphomas
A Single-Center, Open-Label, Phase I Study of Single-Agent GMX1777 Administered as a 24-Hour Infusion Every 3 Weeks to Patients With Refractory Solid Tumors or Lymphomas
GMX1777 is a water-soluble, intravenously-administered prodrug 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.
This is a single-center, open-label, Phase I study of single-agent GMX1777 administered every 3 weeks to patients with CLL, MM, refractory solid tumors or lymphomas. No investigational or commercial agents or therapies other than those described may be administered with the intent to treat the patient's malignancy.
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Solid Tumors and Lymphomas
Drug: GMX1777
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
August 2010
July 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients must have a histologically or cytologically confirmed solid tumor or lymphoma
  • No limitations on allowable type and amount of prior therapy.
  • Patients must have a life expectancy of greater than 8 weeks
  • Patients must have normal organ and marrow function
  • Patients must be willing to submit blood sampling for planned PK analysis
  • Patients must have the ability to understand and willingness to sign a written informed consent form

Exclusion Criteria:

  • No other agents or therapies administered with the intent to treat malignancy
  • Patients with prior exposure to GMX1777 or GMX1778
  • Uncontrolled, intercurrent illness
  • Pregnant women and women who are breast feeding
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT00457574
GEM301
No
Not Provided
Not Provided
Teva Pharmaceutical Industries ( Gemin X )
Gemin X
Not Provided
Study Director: Mark Berger, MD Gemin X, Inc.
Teva Pharmaceutical Industries
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP