A Phase 2, Open-label Trial to Evaluate the Efficacy and Safety of MGCD0103 Administered in Combination With Azacitidine (Vidaza®) to Subjects With Relapsed or Refractory Hodgkin or Non-Hodgkin Lymphoma, and to Evaluate the Pharmacokinetics of Different Formulations of MGCD0103
MGCD0103 and FB-MGCD0103 belong to a class of drugs known as histone deacetylase inhibitors
(also called HDAC inhibitors). Azacitidine belongs to a class of anti-cancer drugs known as
DNA de-methylating agents. Azacitidine (Vidaza®) was approved by the Food and Drug
Administration (FDA) in 2004 for the treatment of myelodysplastic syndromes (MDS).
The combination of MGCD0103 and azacitidine has been given to about 50 people with leukemia
or MDS in other clinical studies. This is the first study where the combination will be
tested in people with lymphoma. Specifically, the study is designed to understand the
following:
- How long single doses of TA-FB-MGCD0103, FB-MGCD0103 and MGCD0103 stay in the body, OR
- How long different doses of TA-FB-MGCD0103 and FB-MGCD0103 stay in the body; and
- How long MGCD0103 stays in the body when given with azacitidine; and
- What effect MGCD0103 and azacitidine have on the body and the study subject's type of
lymphoma; and
- If the genetic and chemical make-up of the study subject's blood and/or tumor play a
role in how she/he responds or does not respond to MGCD0103 and azacitidine.
Interventional
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary efficacy is measured by: 1) PET, CT & physical exam, 2) overall response rate (complete response=disease is gone, partial response=disease has improved). Study treatment continues as long as the cancer is stable & side effects are tolerable.
every other cycle of 28 days each
No
Gregory Reid, MSc, MBA
Study Director
MethylGene Inc.
United States: Food and Drug Administration
103 PH US 2007 CL002
NCT00543582
October 2007
March 2009
Name | Location |
---|---|
Weill Medical College of Cornell University | New York, New York 10021 |
Nevada Cancer Institute | Las Vegas, Nevada 89135 |
St. Francis Cancer Research Foundation | Beech Grove, Indiana 46107 |
University of Texas, MD Anderson | Houston, Texas 77030 |