Study of MGCD0103 Given Three Times Weekly in Patients With Relapsed and Refractory Lymphoma
Study Details
Study Description
Brief Summary
In this study, MGCD0103, a new anticancer drug under investigation, is given three times weekly to patients with relapsed and refractory lymphoma.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 2 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: 1
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Drug: MGCD0103
MGCD0103 given orally three times per week
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Outcome Measures
Primary Outcome Measures
- Response rate [1 year (anticipated)]
Secondary Outcome Measures
- 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)]
Eligibility Criteria
Criteria
Inclusion Criteria:
- Pathologic confirmation of relapsed or refractory lymphoma.
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DLBCL stage II-IV
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Follicular lymphoma
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At least one site of measurable disease (≥ 2.0 cm with conventional techniques; physical exam [PE], CT, X-ray, MRI).
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Prior treatment:
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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.
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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:
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Local symptoms due to progressive or bulky nodal disease.
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Compromise of normal organ function due to progressive or bulky disease.
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Presence of systemic B symptoms.
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Presence of symptomatic extranodal disease.
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Cytopenias due to extensive bone marrow infiltration, autoimmune hemolytic anemia or thrombocytopenia, or hypersplenism.
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ECOG performance status of 0 or 1.
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Aged 18 years or older.
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Laboratory requirements.
Exclusion Criteria:
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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.
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Pregnant or lactating women.
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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.
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Patients with a history of pericardial disease.
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Patients with small, moderate or large pericardial effusions or patients with a diagnosis of pericarditis.
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Patients with significant cardiac abnormalities.
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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.
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Patients who have been treated with any investigational drug within 28 days prior to study initiation.
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Known hypersensitivity to HDAC inhibitors and to any components of MGCD0103.
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Known human immunodeficiency virus (HIV) or active Hepatitis B or C.
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Central nervous system lymphoma and lymphoma involving leptomeningeal area.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Duke University Adult Bone Marrow Transplant Clinic | Durham | North Carolina | United States | 27710 |
2 | MD Anderson Cancer Center | Houston | Texas | United States | 77030 |
3 | Ottawa Hospital - General Campus | Ottawa | Ontario | Canada | K1H 8L6 |
4 | Charles LeMoyne Hospital | Greenfield Park | Quebec | Canada | J4V 2H1 |
5 | Sir Mortimer Davis-Jewish General Hospital | Montreal | Quebec | Canada | H3T 1E2 |
Sponsors and Collaborators
- Mirati Therapeutics Inc.
Investigators
- Study Director: Gregory Reid, MSc, MBA, MethylGene Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 0103-008