Hodgkin Lymphoma Clinical Trial
Official title:
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
The first part of the study is to evaluate and determine if three different forms of MGCD0103 (free base FB-MGCD0103, tartaric acid free base [TA-FB-MGCD0103], and dihydrobromide [2HBr] salt formulation MGCD0103) have the same properties when given to patients with cancer. The second part of the study is to determine whether MGCD0103 administered in combination with azacitidine is effective and safe in treating subjects with relapsed or refractory Hodgkin's lymphoma or non-Hodgkin's lymphoma (NHL) (follicular or diffuse large B-cell [DLBCL]).
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.
;
Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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