Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Celgene Corporation MethylGene Inc. |
---|---|
Information provided by: | Celgene Corporation |
ClinicalTrials.gov Identifier: | NCT00358982 |
MGCD0103 is an experimental drug that belongs to a class of drugs known as the histone deacetylase inhibitors, which may restore normal control in cancer cells by affecting the genes and proteins that are being made. Laboratory tests show that this new investigational anti-cancer drug can slow down the growth of human cancer cells in mice; two clinical research studies are currently being performed in humans with cancer and a similar study is being performed in patients with the same disease.
The purpose of this study is to find out what effect the experimental drug MGCD0103 has on patients with relapsed and refractory Hodgkin's lymphoma.
Condition | Intervention | Phase |
---|---|---|
Hodgkin's Lymphoma |
Drug: MGCD0103 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Phase II Study of MGCD0103 (MG-0103) in Patients With Relapsed or Refractory Hodgkin's Lymphoma |
Estimated Enrollment: | 35 |
Study Start Date: | August 2006 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental |
Drug: MGCD0103
MGCD0103 administered orally three times per wek
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Illinois | |
Rush University Medical Center | |
Chicago, Illinois, United States, 60612 | |
United States, Nebraska | |
Nebraska Medical Center | |
Omaha, Nebraska, United States, 68198 | |
United States, Texas | |
MD Anderson Cancer Center | |
Houston, Texas, United States, 77030 | |
Canada, Ontario | |
Princess Margaret Hospital | |
Toronto, Ontario, Canada, M5G 2M9 | |
Canada, Quebec | |
Royal Victoria Hospital | |
Montreal, Quebec, Canada, H3A 1A1 |
Study Director: | Robert Martell | MethylGene Inc. |
Responsible Party: | MethylGene, Inc. ( Tracy-Ann Patterson, Project Manager ) |
Study ID Numbers: | MGCD0103-010 |
Study First Received: | July 31, 2006 |
Last Updated: | December 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00358982 |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada |
Relapsed or Refractory Hodgkin's Lymphoma Phase II |
Lymphatic Diseases Hodgkin's disease Immunoproliferative Disorders Hodgkin lymphoma, adult |
Lymphoproliferative Disorders Hodgkin Disease Lymphoma |
Neoplasms Neoplasms by Histologic Type Immune System Diseases |