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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00359086
Recruitment Status : Completed
First Posted : August 1, 2006
Last Update Posted : July 1, 2015
Sponsor:
Information provided by (Responsible Party):
Mirati Therapeutics Inc.

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

Condition or disease Intervention/treatment Phase
Lymphoma Drug: MGCD0103 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : August 2006
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1 Drug: MGCD0103
MGCD0103 given orally three times per week


Outcome Measures
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Primary Outcome Measures :
  1. Response rate [ Time Frame: 1 year (anticipated) ]

Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: 1 year (anticipated) ]
  2. Duration of objective response [ Time Frame: 1 year (anticipated) ]
  3. Safety profile [ Time Frame: 1 year (anticipated) ]
  4. Pharmacokinetics [ Time Frame: 1 year (anticipated) ]
  5. Pharmacodynamics [ Time Frame: 1 year (anticipated) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00359086


Locations
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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
Mirati Therapeutics Inc.
Investigators
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Study Director: Gregory Reid, MSc, MBA MethylGene Inc.
More Information
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Responsible Party: Mirati Therapeutics Inc.
ClinicalTrials.gov Identifier: NCT00359086    
Other Study ID Numbers: 0103-008
First Posted: August 1, 2006    Key Record Dates
Last Update Posted: July 1, 2015
Last Verified: June 2015
Keywords provided by Mirati Therapeutics Inc.:
Relapsed and Refractory Lymphoma
Phase II
Additional relevant MeSH terms:
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Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
 Immune System Diseases
Mocetinostat
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action