Study of MGCD0103 Given Three-Times Weekly in Patients With Advanced Solid Tumors or Non-Hodgkin's Lymphoma

This study has been completed.
Sponsor:
Information provided by:
MethylGene Inc.
ClinicalTrials.gov Identifier:
NCT00323934
First received: May 8, 2006
Last updated: November 8, 2011
Last verified: May 2009
  Purpose

In this study, MGCD0103, a new anticancer drug under investigation, is given three times weekly to patients with advanced solid tumors or Non-Hodgkin's Lymphoma.


Condition Intervention Phase
Tumors
Non Hodgkin's Lymphoma
Drug: MGCD0103
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I Study of MGCD0103 Given as a Three-Times Weekly Oral Dose in Patients With Advanced Solid Tumors or Non-Hodgkin's Lymphoma

Resource links provided by NLM:


Further study details as provided by MethylGene Inc.:

Primary Outcome Measures:
  • Safety and tolerability [ Time Frame: 1 year (anticipated) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Clinical response [ Time Frame: 1 year (anticipated) ] [ Designated as safety issue: No ]
  • Pharmacokinetics [ Time Frame: 1 year (anticipated) ] [ Designated as safety issue: No ]
  • Pharmacodynamics (histone acetylation; biomarkers) [ Time Frame: 1 year (anticipated) ] [ Designated as safety issue: No ]

Enrollment: 42
Study Start Date: April 2004
Study Completion Date: October 2008
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
MGCD0103 Oral 2 times weekly
Drug: MGCD0103
Oral dosage 2 times weekly.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have histologically or cytologically documented advanced or metastatic solid malignancy or aggressive NHL with no reasonable likelihood of achieving clinical benefit with existing therapies, that has failed to respond to standard therapy, has progressed despite standard therapy, or for which no standard therapy exists. Aggressive forms of NHL eligible for the study are:

    • Burkitt's lymphoma
    • Mantle cell lymphoma
    • Diffuse large B-cell lymphoma
    • Follicle-center cell lymphoma, large cell
    • Primary mediastinal large B-cell lymphoma
  • Patients with known central nervous system (CNS) metastases may be enrolled if they have received radiotherapy for their CNS disease, if they have been on a stable dose of steroids for at least 1 month prior to study entry, if they have had computed tomography (CT) or magnetic resonance imaging (MRI) of the brain within 1 month of study entry that shows stable disease and if they are free of neurological symptoms.
  • Prior therapies allowed:

    • Cytotoxic therapy
    • Hormonal therapy/other therapy
    • Luteinizing hormone releasing hormone (LHRH) agonist therapy
    • Radiation
    • Surgery
    • Adjuvant therapy - Patients may have had unlimited prior adjuvant therapy. A minimum of 28 days must have passed since the end of last treatment and study initiation. Patients must have recovered from any treatment-related toxicities.
  • ECOG performance status of 0, 1, or 2.
  • Age ≥ 18 years.
  • Minimum life expectancy of at least 3 months.
  • Laboratory requirements

Exclusion Criteria:

  • Patients with a history of another cancer other than basal cell carcinoma or cervical intraepithelial neoplasia (CIN/cervical in situ) unless the previous cancer was treated and the patient has remained disease free for five years or more prior to the current cancer diagnosis. Investigators desiring to enter patients with a second malignancy must discuss with and obtain written approval in advance from the MethylGene Medical Monitor.
  • Pregnant or lactating women. Women of child-bearing potential must have a negative serum pregnancy test documented within 7 days prior to registration on study.
  • Patients and their partners, if either are of child-bearing potential, not using adequate birth control measures throughout the course of the study. Both men and women enrolled on study must agree to use a medically acceptable effective form of contraception during the study and for 90 days following the last dose of study medication. An effective form of contraception is an oral contraceptive or a double barrier method, such as condom with diaphragm.
  • Patients with known meningeal metastasis(es)
  • Patients with active or uncontrolled infections, or with a fever > 38.5 degrees Celsius on the day of scheduled dosing
  • Patients with serious illnesses, medical conditions, or other medical history, including laboratory results, which, in the investigator's opinion, would be likely to interfere with a patient's participation in the study, or with the interpretation of the results
  • Patients who have been treated with any investigational drug within 30 days prior to study initiation (an investigational drug is one for which there is no approved indication), or who are receiving concurrent treatment with other experimental drugs or anti-cancer therapy
  • Known hypersensitivity to histone deacetylase (HDAC) inhibitors or any of the components of MGCD0103
  • Known HIV or hepatitis B or C (active, prior treated, or both).
  • Any condition (e.g., known or suspected poor compliance, psychological instability, geographical location, etc) that, in the judgment of the investigator, may affect the patient's ability to sign the informed consent and undergo study procedures.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00323934

Locations
United States, Maryland
The Johns Hopkins Hospital
Baltimore, Maryland, United States, 21205
Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Canada, Quebec
Hopital Charles LeMoyne
Greenfield Park, Quebec, Canada, J4V 2H1
Sponsors and Collaborators
MethylGene Inc.
Investigators
Study Director: Gregory Reid, MSc, MBA MethylGene Inc.
  More Information

No publications provided

Responsible Party: Gregory Reid, Chief Medical Officer, MethylGene, Inc.
ClinicalTrials.gov Identifier: NCT00323934     History of Changes
Other Study ID Numbers: 0103-002
Study First Received: May 8, 2006
Last Updated: November 8, 2011
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by MethylGene Inc.:
metastatic solid tumor
aggressive non Hodgkin's Lymphoma
Phase I
Advanced Solid Tumors

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on October 23, 2014