Trials Sponsors Conditions Drugs Pricing

Conditions

Hodgkin Lymphoma Non-Hodgkin Lymphoma (Follicular or Large Diffuse B-cell Lymphoma or Mantle Cell Lymphoma)

Outcome Measures

Primary Outcomes (1)

Primary efficacy is measured by: 1) PET, CT & physical exam, 2) overall response rate (complete response=disease is gone, partial response=disease has improved). Study treatment continues as long as the cancer is stable & side effects are tolerable.
every other cycle of 28 days each

Secondary Outcomes (1)

Duration of response defined as: 1)the time of first documented objective response (either complete response or partial response) until the subject's disease gets worse, 2)how long his/her disease is stable.
28 days after the last study drug

Study Arms (1)

1

EXPERIMENTAL

Drug: MGCD0103 and Azacitidine

Interventions

MGCD0103 and AzacitidineDrug

In Part 1 of the study, up to 22 people to enroll will receive a single, oral dose (75 mg gelcap) of MGCD0103 and FB-MGCD0103 during their first 2 weeks in the study. Up to 22 additional people will receive a single dose of both MGCD0103 and TA-FB-MGCE0103. The next group of people to enroll will receive 2 different single doses (25, 50, 100 mg) of FB-MGCD0103 or TA-FB-MGCD0103 during their first 2 weeks in the study. In Part 2 of the study, from Day 1-5 of each 28-day cycle, all subjects will receive a dose of azacitidine (75 mg/m2) either subcutaneously or through an intravenous device, and on days 5, 8, 10, 12, 15, 17, 19, 22, 24, 26, a single, oral dose (85 mg) of MGCD0103 until progression or unacceptable toxicity develops.

Also known as: Vidaza®

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Age ≥ 18 years.
Histologically confirmed diagnosis of classical Hodgkin's lymphoma or NHL (follicular, DLBCL, or mantle cell) and confirmed relapsed or refractory disease. 1)Subjects with a diagnosis of classical Hodgkin's lymphoma MUST have relapsed following a prior autologous, allogeneic or reduced intensity allogeneic stem cell transplant. Subjects who received an allogeneic transplant must have no evidence of graft versus host disease (GVHD), and have discontinued treatment with immunosuppressive agents ≥ 3 months prior to enrollment in this study. 2)Subjects with DLBCL must be ineligible for, or have refused, autologous stem cell transplant, or have relapsed following transplant. 3)Subjects with MCL must have relapsed after prior treatment and not be eligible for autologous stem cell transplant (ASCT) or have relapsed following ASCT. 4)Subjects with NHL who may have received a prior allogeneic stem cell transplant must have no evidence of GVHD, and have discontinued treatment with immunosuppressive agents ≥ 3 months prior to enrollment in this study.

Sponsors & Collaborators

Mirati Therapeutics Inc.
Industrylead

Study Sites (4)

St. Francis Cancer Research Foundation

Beech Grove, Indiana, 46107, United States

Nevada Cancer Institute

Las Vegas, Nevada, 89135, United States

Weill Medical College of Cornell University

New York, New York, United States

University of Texas, MD Anderson

Houston, Texas, 77030, United States

MeSH Terms

Conditions

Hodgkin DiseaseLymphoma, Non-HodgkinLymphoma, Large B-Cell, DiffuseLymphoma, Mantle-Cell

Interventions

mocetinostatAzacitidine

Condition Hierarchy (Ancestors)

LymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Officials

Gregory Reid, MSc, MBA
MethylGene Inc.
STUDY DIRECTOR

Enrollment

23 participants (actual enrollment reported by the registry).

Study Design

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

Study Record Dates

First Submitted

October 11, 2007

First Posted

October 15, 2007

Study Start

October 2007

Date type not reported

This date has not been verified as actual or estimated.

You may not qualify if:

Prior HDAC inhibitor and azacitidine combination therapy.
Known hypersensitivity to azacitidine, HDAC inhibitors, and/or any components of MGCD0103, FB-MGCD0103, or TA-FB-MGCD0103 capsules and or azacitidine formulation components.
Any condition that will put the subject at undue risk or discomfort as a result of adherence to study procedures (eg, requirement to take MGCD0103 with Gatorade®).
Previous or concurrent malignancy except adequately treated basal cell or squamous skin cancer; in situ carcinoma of the cervix, or other solid tumor treated curatively, and without evidence of recurrence for at least 3 years prior to study entry.
Presence of significant involvement of the liver by lymphoma and impaired synthetic function as indicated by hypoalbuminemia of \< 1.0 x LLN.
Active and uncontrolled clinically significant infection.
Known Hepatitis B surface antigen (HepB SAg) positive or Hepatitis C antibody positive.
Known infection with human immunodeficiency virus (HIV).
History of melena or hematemesis within the last 3 months.
Known central nervous system metastases.
Less than 4 weeks elapsed since any major surgery.
Pregnant or lactating women. Women of child-bearing potential (WOCBP) must have a negative serum pregnancy test within 7 days of beginning Part 1 of the study.
WOCBP and men whose partners are WOCBP must use two acceptable methods of contraception while enrolled in this study, and for a period of 3 months following study drug treatment. Subjects unwilling or unable to follow this guideline will be excluded.
Concurrent chronic treatment with therapeutic doses of systemic steroids.
Prior or active disease or conditions that, in the opinion of the investigator, may interfere with the procedures or evaluations to be conducted in the study. This includes, but is not limited to, uncontrolled intercurrent illnesses such as symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements.

Study Stopped

MGCD0103 Administered in Combination With Azacitidine (Vidaza®) to Subjects With Relapsed or Refractory Hodgkin or Non-Hodgkin Lymphoma

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

1

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (4)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (1)

1

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (4)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations