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.

July 31, 2006
August 1, 2006
July 3, 2015
August 2006
January 2009   (Final data collection date for primary outcome measure)
Success rate [ Time Frame: 1 year (anticipated) ]
  • Estimate the success rate (SD + PR + CR) with MG-0103 in patients with relapsed or refractory classical Hodgkin's lymphoma using physical exam
  • Imaging studies to evaluate disease (eg, CT, MRI)
  • Bone marrow biopsy
  • PET scan
Complete list of historical versions of study NCT00358982 on Archive Site
  • Progression-free survival [ Time Frame: 1 year (anticipated) ]
  • Duration of objective response [ Time Frame: 1 year (anticipated) ]
  • Safety profile [ Time Frame: 1 year (anticipated) ]
  • Pharmacodynamics (biomarkers) [ Time Frame: 1 year (anticipated) ]
  • Estimate duration of objective response
  • Estimate progression-free survival
  • Characterize the safety profile of MG-0103
  • Assess biomarkers and predictive markers for efficacy or toxicity of MG-0103
Not Provided
Not Provided
Study of MGCD0103 (MG-0103) in Patients With Relapsed or Refractory Hodgkin's Lymphoma
A Phase II Study of MGCD0103 (MG-0103) in Patients With Relapsed or Refractory Hodgkin's Lymphoma

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.

Not Provided
Phase 2
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Hodgkin's Lymphoma
Drug: MGCD0103
MGCD0103 administered orally three times per wek
Experimental: 1
Intervention: Drug: MGCD0103
Younes A, Oki Y, Bociek RG, Kuruvilla J, Fanale M, Neelapu S, Copeland A, Buglio D, Galal A, Besterman J, Li Z, Drouin M, Patterson T, Ward MR, Paulus JK, Ji Y, Medeiros LJ, Martell RE. Mocetinostat for relapsed classical Hodgkin's lymphoma: an open-label, single-arm, phase 2 trial. Lancet Oncol. 2011 Dec;12(13):1222-8. doi: 10.1016/S1470-2045(11)70265-0. Epub 2011 Oct 25.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
January 2009
January 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Canada,   United States
Not Provided
Not Provided
Mirati Therapeutics Inc.
Mirati Therapeutics Inc.
Not Provided
Study Director: Gregory Reid, MSc, MBA MethylGene Inc.
Mirati Therapeutics Inc.
June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP