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

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

Official Title
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A Phase II Study of MGCD0103 (MG-0103) Given Three Times Weekly in Patients With Relapsed and Refractory Lymphoma

Conditions
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Lymphoma

Intervention / Treatment
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* Drug: MGCD0103


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pathologic confirmation of relapsed or refractory lymphoma. DLBCL stage II-IV Follicular lymphoma At least one site of measurable disease (≥ 2.0 cm with conventional techniques; physical exam [PE], CT, X-ray, MRI). Prior treatment: 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. 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: Local symptoms due to progressive or bulky nodal disease. Compromise of normal organ function due to progressive or bulky disease. Presence of systemic B symptoms. Presence of symptomatic extranodal disease. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: MGCD0103<br>* MGCD0103 given orally three times per week<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate |  | 1 year (anticipated) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  | 1 year (anticipated) | 
| Duration of objective response |  | 1 year (anticipated) | 
| Safety profile |  | 1 year (anticipated) | 
| Pharmacokinetics |  | 1 year (anticipated) | 
| Pharmacodynamics |  | 1 year (anticipated) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Relapsed and Refractory Lymphoma, Phase II