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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


Phase 1
18 Years
N/A
Not Enrolling
Both
Solid Tumors and Lymphomas

Thank you

Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determine the recommended Phase II dose; Characterize the dose-limiting toxicities; Determine the pharmacokinetic parameters

Principal Investigator

Mark Berger, MD

Investigator Role:

Study Director

Investigator Affiliation:

Gemin X, Inc.

Authority:

United States: Food and Drug Administration

Study ID:

GEM301

NCT ID:

NCT00457574

Start Date:

March 2007

Completion Date:

August 2010

Related Keywords:

  • Solid Tumors and Lymphomas
  • Lymphoma
  • Neoplasms

Name

Location
Georgetown University Medical Center Washington, District of Columbia  20007
Maria Delioukina Duarte, California  91010
University of Maryland at Baltimore Baltimore, Maryland  21201