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

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. Identifier: NCT00457574
Recruitment Status : Withdrawn (Study terminated prematurely due to financial constraints.)
First Posted : April 6, 2007
Last Update Posted : August 28, 2013
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Gemin X )

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Solid Tumors and Lymphomas Drug: GMX1777 Phase 1

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : March 2007
Actual Primary Completion Date : July 2009
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Primary Outcome Measures :
  1. Determine the recommended Phase II dose; Characterize the dose-limiting toxicities; Determine the pharmacokinetic parameters [ Time Frame: 52 weeks ]

Secondary Outcome Measures :
  1. Describe observed tumor responses [ Time Frame: 52 weeks ]

Information from the National Library of Medicine

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

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

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 identifier (NCT number): NCT00457574

Sponsors and Collaborators
Gemin X
Study Director: Mark Berger, MD Gemin X, Inc.

Responsible Party: Gemin X Identifier: NCT00457574     History of Changes
Other Study ID Numbers: GEM301
First Posted: April 6, 2007    Key Record Dates
Last Update Posted: August 28, 2013
Last Verified: August 2013

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases