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

Primary Purpose

Lymphoma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
MGCD0103
Sponsored by
Mirati Therapeutics Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma focused on measuring Relapsed and Refractory Lymphoma, Phase II

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. 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.

Sites / Locations

  • Duke University Adult Bone Marrow Transplant Clinic
  • MD Anderson Cancer Center
  • Ottawa Hospital - General Campus
  • Charles LeMoyne Hospital
  • Sir Mortimer Davis-Jewish General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

Response rate

Secondary Outcome Measures

Progression-free survival
Duration of objective response
Safety profile
Pharmacokinetics
Pharmacodynamics

Full Information

First Posted
July 31, 2006
Last Updated
June 4, 2015
Sponsor
Mirati Therapeutics Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00359086
Brief Title
Study of MGCD0103 Given Three Times Weekly in Patients With Relapsed and Refractory Lymphoma
Official Title
A Phase II Study of MGCD0103 (MG-0103) Given Three Times Weekly in Patients With Relapsed and Refractory Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
August 2006 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mirati Therapeutics Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma
Keywords
Relapsed and Refractory Lymphoma, Phase II

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
MGCD0103
Intervention Description
MGCD0103 given orally three times per week
Primary Outcome Measure Information:
Title
Response rate
Time Frame
1 year (anticipated)
Secondary Outcome Measure Information:
Title
Progression-free survival
Time Frame
1 year (anticipated)
Title
Duration of objective response
Time Frame
1 year (anticipated)
Title
Safety profile
Time Frame
1 year (anticipated)
Title
Pharmacokinetics
Time Frame
1 year (anticipated)
Title
Pharmacodynamics
Time Frame
1 year (anticipated)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory Reid, MSc, MBA
Organizational Affiliation
MethylGene Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Duke University Adult Bone Marrow Transplant Clinic
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Ottawa Hospital - General Campus
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
Charles LeMoyne Hospital
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2H1
Country
Canada
Facility Name
Sir Mortimer Davis-Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada

12. IPD Sharing Statement

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

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