Study of MGCD0103 Given Three Times Weekly in Patients With Relapsed and Refractory Lymphoma

• Status: Completed
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

Summary

In this study, MGCD0103, a new anticancer drug under investigation, is given three times weekly to patients with relapsed and refractory lymphoma.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mirati Therapeutics Inc.
• Treatments: Mocetinostat

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.