NCT00359086

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P75+ for phase_2 lymphoma

Timeline
Completed

Started Aug 2006

Geographic Reach
2 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 1, 2006

Completed
Same day until next milestone

Study Start

First participant enrolled

August 1, 2006

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

July 1, 2015

Status Verified

June 1, 2015

Enrollment Period

5.4 years

First QC Date

July 31, 2006

Last Update Submit

June 4, 2015

Conditions

Lymphoma

Keywords

Relapsed and Refractory LymphomaPhase II

Outcome Measures

Primary Outcomes (1)

  • Response rate

    1 year (anticipated)

Secondary Outcomes (5)

  • Progression-free survival

    1 year (anticipated)

  • Duration of objective response

    1 year (anticipated)

  • Safety profile

    1 year (anticipated)

  • Pharmacokinetics

    1 year (anticipated)

  • Pharmacodynamics

    1 year (anticipated)

Study Arms (1)

1

EXPERIMENTAL
Drug: MGCD0103

Interventions

MGCD0103DRUG

MGCD0103 given orally three times per week

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pathologic confirmation of relapsed or refractory lymphoma.
  • DLBCL stage II-IV
  • Follicular lymphoma
  • At least one site of measurable disease (≥ 2.0 cm with conventional techniques; physical exam \[PE\], CT, X-ray, MRI).
  • Prior treatment:
  • 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.
  • 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:
  • Local symptoms due to progressive or bulky nodal disease.
  • Compromise of normal organ function due to progressive or bulky disease.
  • Presence of systemic B symptoms.
  • Presence of symptomatic extranodal disease.
  • 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.
  • +1 more criteria

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Duke University Adult Bone Marrow Transplant Clinic

Durham, North Carolina, 27710, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Ottawa Hospital - General Campus

Ottawa, Ontario, K1H 8L6, Canada

Location

Charles LeMoyne Hospital

Greenfield Park, Quebec, J4V 2H1, Canada

Location

Sir Mortimer Davis-Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

MeSH Terms

Conditions

LymphomaRecurrence

Interventions

mocetinostat

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Gregory Reid, MSc, MBA

    MethylGene Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2006

First Posted

August 1, 2006

Study Start

August 1, 2006

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

July 1, 2015

Record last verified: 2015-06

Locations

US(2)CA(3)