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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MethylGene Inc.
ClinicalTrials.gov Identifier:
NCT00359086
First received: July 31, 2006
Last updated: October 23, 2013
Last verified: October 2013
  Purpose

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


Condition Intervention Phase
Lymphoma
Drug: MGCD0103
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of MGCD0103 (MG-0103) Given Three Times Weekly in Patients With Relapsed and Refractory Lymphoma

Resource links provided by NLM:


Further study details as provided by MethylGene Inc.:

Primary Outcome Measures:
  • Response rate [ Time Frame: 1 year (anticipated) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: 1 year (anticipated) ] [ Designated as safety issue: Yes ]
  • Duration of objective response [ Time Frame: 1 year (anticipated) ] [ Designated as safety issue: No ]
  • Safety profile [ Time Frame: 1 year (anticipated) ] [ Designated as safety issue: Yes ]
  • Pharmacokinetics [ Time Frame: 1 year (anticipated) ] [ Designated as safety issue: No ]
  • Pharmacodynamics [ Time Frame: 1 year (anticipated) ] [ Designated as safety issue: No ]

Enrollment: 74
Study Start Date: August 2006
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: MGCD0103
MGCD0103 given orally three times per week

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00359086

Locations
United States, North Carolina
Duke University Adult Bone Marrow Transplant Clinic
Durham, North Carolina, United States, 27710
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Canada, Ontario
Ottawa Hospital - General Campus
Ottawa, Ontario, Canada, K1H 8L6
Canada, Quebec
Charles LeMoyne Hospital
Greenfield Park, Quebec, Canada, J4V 2H1
Sir Mortimer Davis-Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Sponsors and Collaborators
MethylGene Inc.
Investigators
Study Director: Gregory Reid, MSc, MBA MethylGene Inc.
  More Information

No publications provided

Responsible Party: MethylGene Inc.
ClinicalTrials.gov Identifier: NCT00359086     History of Changes
Other Study ID Numbers: 0103-008
Study First Received: July 31, 2006
Last Updated: October 23, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by MethylGene Inc.:
Relapsed and Refractory Lymphoma
Phase II

Additional relevant MeSH terms:
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
N-(2-aminophenyl)-4-((4-pyridin-3-ylpyrimidin-2-ylamino)methyl)benzamide
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014