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.

Study Overview

• Status: Terminated
• Conditions: Hodgkin's Lymphoma
• Intervention / Treatment: Drug: MGCD0103

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2M9
      • Princess Margaret Hospital
  • Quebec
    • Montreal, Quebec, Canada, H3A 1A1
      • Royal Victoria Hospital
• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Rush University Medical Center
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • Nebraska Medical Center
  • Texas
    • Houston, Texas, United States, 77030
      • MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Drug: MGCD0103; MGCD0103 administered orally three times per wek

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Success rate	1 year (anticipated)

Secondary Outcome Measures

Outcome Measure	Time Frame
Progression-free survival	1 year (anticipated)
Duration of objective response	1 year (anticipated)
Safety profile	1 year (anticipated)
Pharmacodynamics (biomarkers)	1 year (anticipated)

Collaborators and Investigators

• Sponsor: Mirati Therapeutics Inc.
• Investigators: Study Director: Gregory Reid, MSc, MBA, MethylGene Inc.

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2006
• Primary Completion (Actual): January 1, 2009
• Study Completion (Actual): January 1, 2009

Study Registration Dates

• First Submitted: July 31, 2006
• First Submitted That Met QC Criteria: July 31, 2006
• First Posted (Estimate): August 1, 2006

Study Record Updates

• Last Update Posted (Estimate): July 3, 2015
• Last Update Submitted That Met QC Criteria: June 5, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: Phase II; Relapsed or Refractory Hodgkin's Lymphoma
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma; Hodgkin Disease; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Histone Deacetylase Inhibitors; Mocetinostat
• Other Study ID Numbers: 0103-010