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. Identifier: NCT00359086
Recruitment Status : Completed
First Posted : August 1, 2006
Last Update Posted : July 1, 2015
Information provided by (Responsible Party):
Mirati Therapeutics Inc.

July 31, 2006
August 1, 2006
July 1, 2015
August 2006
January 2012   (Final data collection date for primary outcome measure)
Response rate [ Time Frame: 1 year (anticipated) ]
  • Estimate the overall response rate (CR + CRu + PR) with MG-0103 in patients with relapsed or refractory lymphoma. There will be 2 cohorts: 1) Diffuse large B-cell lymphoma (DLBCL); 2) Follicular lymphoma.
  • Imaging studies will be used to evaluate disease (CT-scan, MRI, PET).
  • Bone marrow biopsies (if indicated).
Complete list of historical versions of study NCT00359086 on Archive Site
  • Progression-free survival [ Time Frame: 1 year (anticipated) ]
  • Duration of objective response [ Time Frame: 1 year (anticipated) ]
  • Safety profile [ Time Frame: 1 year (anticipated) ]
  • Pharmacokinetics [ Time Frame: 1 year (anticipated) ]
  • Pharmacodynamics [ Time Frame: 1 year (anticipated) ]
  • Estimate duration of objective response in each population.
  • Estimate progression-free survival for each population.
  • Characterize the safety profile of MG-0103 in each population.
  • Assess biomarkers and predictive markers for MG-0103
  • Evaluate pharmacokinetic parameters of MG-0103 in these populations (for patients at selected centers).
Not Provided
Not Provided
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.
Not Provided
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Drug: MGCD0103
MGCD0103 given orally three times per week
Experimental: 1
Intervention: Drug: MGCD0103
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
January 2012
January 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
Not Provided
Not Provided
Mirati Therapeutics Inc.
Mirati Therapeutics Inc.
Not Provided
Study Director: Gregory Reid, MSc, MBA MethylGene Inc.
Mirati Therapeutics Inc.
June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP