Study of MGCD0103 (MG-0103) in Patients With Relapsed or Refractory Hodgkin's Lymphoma
This study has been terminated.
Sponsor:
MethylGene Inc.
Information provided by:
MethylGene Inc.
ClinicalTrials.gov Identifier:
NCT00358982
First received: July 31, 2006
Last updated: April 28, 2011
Last verified: January 2009
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Purpose
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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Study of MGCD0103 (MG-0103) in Patients With Relapsed or Refractory Hodgkin's Lymphoma |
Resource links provided by NLM:
Further study details as provided by MethylGene Inc.:
Primary Outcome Measures:
- Success rate [ Time Frame: 1 year (anticipated) ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ]
- Pharmacodynamics (biomarkers) [ Time Frame: 1 year (anticipated) ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 35 |
| Study Start Date: | August 2006 |
| Study Completion Date: | January 2009 |
| Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: MGCD0103
MGCD0103 administered orally three times per wek
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Pathologic confirmation of relapsed or refractory classical Hodgkin's lymphoma.
- The patient has at least one site of measurable disease (≥ 2.0 cm) as measured by conventional techniques such as CT or MRI.
- Prior treatment: there is no limit to number of prior therapies. Patients who had prior allogeneic stem cell transplants and do not have evidence of graft versus host disease and are not receiving immunosuppressive agents are eligible if they meet all other inclusion criteria.
- ECOG performance status of 0 or 1.
- Aged 18 years or older (no safety data yet for ages < 18).
- Laboratory requirements (must be done within 7 days prior to study initiation).
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. Women of child-bearing potential (WOCBP) must have a negative serum pregnancy test documented within 7 days prior to start of study drug.
- WOCBP and men whose partners are WOCBP must use an acceptable method of contraception while enrolled in this study, and for a period of 3 months following study drug treatment.
- Patients with uncontrolled intercurrent illness, active or uncontrolled infections, or a fever > 38.5°C (not due to tumor fever) on the day of scheduled dosing.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00358982
Locations
| 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 | |
Sponsors and Collaborators
MethylGene Inc.
Investigators
| Study Director: | Gregory Reid, MSc, MBA | MethylGene Inc. |
More Information
No publications provided by MethylGene Inc.
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Gregory Reid, Chief Medical Officer, MethylGene, Inc. |
| ClinicalTrials.gov Identifier: | NCT00358982 History of Changes |
| Other Study ID Numbers: | 0103-010 |
| Study First Received: | July 31, 2006 |
| Last Updated: | April 28, 2011 |
| Health Authority: | United States: Food and Drug Administration Canada: Health Canada |
Keywords provided by MethylGene Inc.:
|
Relapsed or Refractory Hodgkin's Lymphoma Phase II |
Additional relevant MeSH terms:
|
Hodgkin Disease Lymphoma Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders |
Immune System Diseases N-(2-aminophenyl)-4-((4-pyridin-3-ylpyrimidin-2-ylamino)methyl)benzamide Histone Deacetylase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013