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

Phase 2

Completed

• Conditions: Lymphoma
• Interventions: Drug: MGCD0103

• Registration Number: NCT00359086
• Lead Sponsor: Mirati Therapeutics Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-07-31
• Study First Submitted QC: 2006-07-31
• Study Start: 2006-08
• Study First Posted: 2006-08-01
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2015-06
• Disposition First Submitted: 2015-06-04
• Disposition First Submitted QC: 2015-06-04
• Last Update Submitted: 2015-06-04
• Disposition First Posted: 2015-07-01
• Last Update Posted: 2015-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	MGCD0103	-

Primary Outcome Measures

Name	Time	Method
Response rate	1 year (anticipated)

Secondary Outcome Measures

Name	Time	Method
Progression-free survival	1 year (anticipated)
Safety profile	1 year (anticipated)
Duration of objective response	1 year (anticipated)
Pharmacokinetics	1 year (anticipated)
Pharmacodynamics	1 year (anticipated)

Trial Locations

Locations (5)

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Sir Mortimer Davis-Jewish General Hospital; 🇨🇦 Montreal, Quebec, Canada

Duke University Adult Bone Marrow Transplant Clinic; 🇺🇸 Durham, North Carolina, United States

Charles LeMoyne Hospital; 🇨🇦 Greenfield Park, Quebec, Canada

Ottawa Hospital - General Campus; 🇨🇦 Ottawa, Ontario, Canada