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

July 31, 2006
October 23, 2013
August 2006
January 2012   (final data collection date for primary outcome measure)
Response rate [ Time Frame: 1 year (anticipated) ] [ Designated as safety issue: No ]
  • Bone marrow biopsies (if indicated).
  • 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).
Complete list of historical versions of study NCT00359086 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Lymphoma
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
74
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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00359086
0103-008
No
MethylGene Inc.
MethylGene Inc.
Not Provided
Study Director: Gregory Reid, MSc, MBA MethylGene Inc.
MethylGene Inc.
October 2013

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