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

NCT ID: NCT00457574

Last Updated: 2013-08-28

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2010-08-31

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.

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.

Conditions

Solid Tumors and Lymphomas

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

GMX1777

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gemin X

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark Berger, MD

Role: STUDY_DIRECTOR

Gemin X, Inc.

Other Identifiers

GEM301

Identifier Type: -

Identifier Source: org_study_id