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

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

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

Study Overview

• Status: Completed
• Conditions: Lymphoma
• Intervention / Treatment: Drug: MGCD0103

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1H 8L6
      • Ottawa Hospital - General Campus
  • Quebec
    • Greenfield Park, Quebec, Canada, J4V 2H1
      • Charles LeMoyne Hospital
    • Montreal, Quebec, Canada, H3T 1E2
      • Sir Mortimer Davis-Jewish General Hospital
• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Adult Bone Marrow Transplant Clinic
  • Texas
    • Houston, Texas, United States, 77030
      • MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: MGCD0103; MGCD0103 given orally three times per week

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Response rate	1 year (anticipated)

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Mirati Therapeutics Inc.
• Investigators: Study Director: Gregory Reid, MSc, MBA, MethylGene Inc.

Study record dates

Study Major Dates

• Study Start: August 1, 2006
• Primary Completion (Actual): January 1, 2012
• Study Completion (Actual): January 1, 2012

Study Registration Dates

• First Submitted: July 31, 2006
• First Submitted That Met QC Criteria: July 31, 2006
• First Posted (Estimate): August 1, 2006

Study Record Updates

• Last Update Posted (Estimate): July 1, 2015
• Last Update Submitted That Met QC Criteria: June 4, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: Phase II; Relapsed and Refractory Lymphoma
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Histone Deacetylase Inhibitors; Mocetinostat
• Other Study ID Numbers: 0103-008