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This study has been withdrawn prior to enrollment.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:
Information provided by (Responsible Party):
Teva Pharmaceutical Industries ( Gemin X )
ClinicalTrials.gov Identifier:
NCT00457574
First received: April 5, 2007
Last updated: August 27, 2013
Last verified: August 2013
  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: 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:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • Determine the recommended Phase II dose; Characterize the dose-limiting toxicities; Determine the pharmacokinetic parameters [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Describe observed tumor responses [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Enrollment: 0
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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: NCT00457574     History of Changes
Other Study ID Numbers: GEM301
Study First Received: April 5, 2007
Last Updated: August 27, 2013
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 July 26, 2014