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

This study has been terminated.
Sponsor:
Information provided by:
MethylGene Inc.
ClinicalTrials.gov Identifier:
NCT00358982
First received: July 31, 2006
Last updated: October 23, 2013
Last verified: October 2013

July 31, 2006
October 23, 2013
August 2006
January 2009   (final data collection date for primary outcome measure)
Success rate [ Time Frame: 1 year (anticipated) ] [ Designated as safety issue: No ]
  • Bone marrow biopsy
  • 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)
  • PET scan
Complete list of historical versions of study NCT00358982 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
35
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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00358982
0103-010
No
Gregory Reid, Chief Medical Officer, MethylGene, Inc.
MethylGene Inc.
Not Provided
Study Director: Gregory Reid, MSc, MBA MethylGene Inc.
MethylGene Inc.
October 2013

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