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

Launched by MIRATI THERAPEUTICS INC. · Jul 31, 2006

Keywords

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Gender

ALL

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.