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
18 Years
N/A
Both
Solid Tumors and Lymphomas
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 |
