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Study of MGCD0103 (MG-0103) in Patients With Relapsed or Refractory Hodgkin's Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00358982
Recruitment Status : Terminated
First Posted : August 1, 2006
Last Update Posted : July 3, 2015
Information provided by (Responsible Party):
Mirati Therapeutics Inc.

Brief Summary:

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 or disease Intervention/treatment Phase
Hodgkin's Lymphoma Drug: MGCD0103 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of MGCD0103 (MG-0103) in Patients With Relapsed or Refractory Hodgkin's Lymphoma
Study Start Date : August 2006
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1 Drug: MGCD0103
MGCD0103 administered orally three times per wek

Primary Outcome Measures :
  1. Success rate [ Time Frame: 1 year (anticipated) ]

Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: 1 year (anticipated) ]
  2. Duration of objective response [ Time Frame: 1 year (anticipated) ]
  3. Safety profile [ Time Frame: 1 year (anticipated) ]
  4. Pharmacodynamics (biomarkers) [ Time Frame: 1 year (anticipated) ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00358982

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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
Mirati Therapeutics Inc.
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Study Director: Gregory Reid, MSc, MBA MethylGene Inc.
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Mirati Therapeutics Inc. Identifier: NCT00358982    
Other Study ID Numbers: 0103-010
First Posted: August 1, 2006    Key Record Dates
Last Update Posted: July 3, 2015
Last Verified: June 2015
Keywords provided by Mirati Therapeutics Inc.:
Relapsed or Refractory Hodgkin's Lymphoma
Phase II
Additional relevant MeSH terms:
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Hodgkin Disease
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action