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

NCT ID: NCT00359086

Last Updated: 2015-07-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-08-31
• Study Completion Date: 2012-01-31

Brief Summary

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

Conditions

Lymphoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

MGCD0103

Intervention Type: DRUG

MGCD0103 given orally three times per week

Interventions

MGCD0103

MGCD0103 given orally three times per week

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mirati Therapeutics Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gregory Reid, MSc, MBA

Role: STUDY_DIRECTOR

MethylGene Inc.

Locations

Duke University Adult Bone Marrow Transplant Clinic

Durham, North Carolina, United States

MD Anderson Cancer Center

Houston, Texas, United States

Ottawa Hospital - General Campus

Ottawa, Ontario, Canada

Charles LeMoyne Hospital

Greenfield Park, Quebec, Canada

Sir Mortimer Davis-Jewish General Hospital

Montreal, Quebec, Canada

Countries

United States; Canada

Other Identifiers

0103-008

Identifier Type: -

Identifier Source: org_study_id