Clinical trial NCT00359086 (phase 2, status: completed)
Conditions: lymphoma
ICD codes: S33.110S, S33.111S, S33.120S, S33.121S, S33.130S, S33.131S, S33.140S
Drugs: mgcd0103
SMILES: NC1=CC=CC=C1NC(=O)C1=CC=C(CNC2=NC=CC(=N2)C2=CC=CN=C2)C=C1
Eligibility criteria:

        Inclusion Criteria:

          -  Pathologic confirmation of relapsed or refractory lymphoma.

               1. DLBCL stage II-IV

               2. Follicular lymphoma

          -  At least one site of measurable disease (≥ 2.0 cm with conventional techniques;
             physical exam [PE], CT, X-ray, MRI).

          -  Prior treatment:

               1. DLBCL cohort: Disease progression following initial therapy and transplant
                  (unless the patient is ineligible or refused transplant). There is no limit to
                  number of prior therapies.

               2. Follicular lymphoma cohort: Follicular lymphoma that is relapsed following or
                  refractory to standard therapy and/or existing therapies or are not eligible for
                  or are unlikely to achieve clinical benefit from those therapies. Patients must
                  have failed 3 or more prior therapies.

          -  Must have at least one of the following considered related to disease:

               1. Local symptoms due to progressive or bulky nodal disease.

               2. Compromise of normal organ function due to progressive or bulky disease.

               3. Presence of systemic B symptoms.

               4. Presence of symptomatic extranodal disease.

               5. Cytopenias due to extensive bone marrow infiltration, autoimmune hemolytic anemia
                  or thrombocytopenia, or hypersplenism.

          -  ECOG performance status of 0 or 1.

          -  Aged 18 years or older.

          -  Laboratory requirements.

        Exclusion Criteria:

          -  Patients with another active cancer (excluding basal cell carcinoma or cervical
             intraepithelial neoplasia [CIN/cervical in situ] or melanoma in situ). Prior history
             of cancer is allowed, as long as there is no active disease.

          -  Pregnant or lactating women.

          -  Patients with uncontrolled intercurrent illness, active or uncontrolled infections, or
             a fever >38.5 Celsius (not due to tumor fever) on the day of scheduled dosing.

          -  Patients with a history of pericardial disease.

          -  Patients with small, moderate or large pericardial effusions or patients with a
             diagnosis of pericarditis.

          -  Patients with significant cardiac abnormalities.

          -  Patients with serious illnesses, medical conditions, or other medical history which
             would be likely to interfere with patient's participation in the study or with the
             interpretation of the results.

          -  Patients who have been treated with any investigational drug within 28 days prior to
             study initiation.

          -  Known hypersensitivity to HDAC inhibitors and to any components of MGCD0103.

          -  Known human immunodeficiency virus (HIV) or active Hepatitis B or C.

          -  Central nervous system lymphoma and lymphoma involving leptomeningeal area.