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

This study has been terminated.
(Study terminated prematurely due to financial constraints.)
Sponsor:
Information provided by:
Gemin X
ClinicalTrials.gov Identifier:
NCT00457574
First received: April 5, 2007
Last updated: September 14, 2010
Last verified: September 2010
History of Changes
  Purpose

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 Intervention Phase
Solid Tumors and Lymphomas
 Drug: GMX1777
 Phase 1

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 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lymphoma
U.S. FDA Resources

Further study details as provided by Gemin X:

Primary Outcome Measures:
  • Determine the recommended Phase II dose; Characterize the dose-limiting toxicities; Determine the pharmacokinetic parameters

Secondary Outcome Measures:
  • Describe observed tumor responses

Estimated Enrollment: 18
Study Start Date: March 2007
Study Completion Date: August 2010
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00457574

Locations
United States, California
Maria Delioukina
Duarte, California, United States, 91010
United States, District of Columbia
Georgetown University Medical Center
Washington, District of Columbia, United States, 20007
United States, Maryland
University of Maryland at Baltimore
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
Gemin X
Investigators
Study Director: Mark Berger, MD Gemin X, Inc.
  More Information

No publications provided

Responsible Party: Jean Viallet, MD, Gemin X Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00457574     History of Changes
Other Study ID Numbers: GEM301
Study First Received: April 5, 2007
Last Updated: September 14, 2010
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 22, 2013