Status:
COMPLETED
Study of MGCD0103 Given Three Times Weekly in Patients With Relapsed and Refractory Lymphoma
Lead Sponsor:
Mirati Therapeutics Inc.
Conditions:
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
In this study, MGCD0103, a new anticancer drug under investigation, is given three times weekly to patients with relapsed and refractory lymphoma.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT00359086
Start Date
August 1 2006
End Date
January 1 2012
Last Update
July 1 2015
Active Locations (5)
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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