MGCD0103 in Elderly Patients With Previously Untreated AML/High Risk MDS or Adults With Relapsed/Refractory Disease

This study has been terminated.
(The Clinical Development Program for MGCD0103 is being re-evaluated)
Sponsor:
Information provided by:
MethylGene Inc.
ClinicalTrials.gov Identifier:
NCT00374296
First received: September 7, 2006
Last updated: October 23, 2013
Last verified: October 2013
  Purpose

In this study, MGCD0103, a new anticancer drug under investigation, is given three times per week to elderly patients with previously untreated acute myelogenous leukemia/high risk myelodysplastic syndrome or adults with relapsed/refractory disease.


Condition Intervention Phase
Myelogenous Leukemia, Acute
Myelodysplastic Syndromes
Drug: MGCD0103
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of MGCD0103 (MG-0103) in Patients With Acute Myelogenous Leukemia/High Risk MDS Who Are Elderly and Have Previously Untreated Disease or Who Are Adult and Have Relapsed/Refractory Disease

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 ]
  • Response rate [ Time Frame: 1 year (anticipated) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]
  • Pharmacokinetics [ Time Frame: 1 year (anticipated) ] [ Designated as safety issue: No ]
  • Pharmacodynamics [ Time Frame: 1 year (anticipated) ] [ Designated as safety issue: No ]

Enrollment: 35
Study Start Date: September 2006
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: 1
Elderly (≥65 years) untreated arm
Experimental: 2
Relapsed/Refractory Arm
Drug: MGCD0103
MGCD0103 administered orally three-times per week

  Eligibility

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

Inclusion Criteria:

  • Pathologic confirmation of AML or high risk MDS.
  • Elderly cohort (70 years of age or more): no prior chemotherapy treatment for AML/high risk MDS and not currently candidates for intensive chemotherapy.
  • Relapsed/refractory cohort (18 years of age or more): relapsed or refractory to prior treatment.
  • ECOG performance status of 0 or 1.
  • Total bilirubin < 1.5 x upper limit of normal (ULN).
  • AST/SGOT and ALT/SGPT < 2.5 x ULN.
  • Serum creatinine < 1.5 x ULN.
  • Patients must read, understand, and sign a written informed consent form (ICF).
  • Women of childbearing potential and male patients' female partners must use an acceptable method of contraception while on study, and for 3 months after study drug treatment.

Exclusion Criteria:

  • Pregnant or lactating women.
  • Patients with uncontrolled, intercurrent illness, active or uncontrolled infections, or a fever > 38.5C (not due to tumor fever) on the day of scheduled dosing.
  • Patients with serious illnesses or medical conditions, including laboratory results, which, in the investigator's opinion, would interfere with a patient's participation, or with the interpretation of the results.
  • Patients treated with an investigational drug within 30 days prior to study initiation.
  • Known hypersensitivity to HDAC inhibitors or to any of the components of MG-0103.
  • Known HIV or active hepatitis B or C.
  • Any condition that may affect the patient's ability to sign the ICF and undergo study procedures.
  • Any conditions that will put the patient at undue risk or discomfort as a result of adherence to study procedures.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00374296

Locations
United States, Missouri
Veterans Affairs Medical Center
Kansas City, Missouri, United States, 64128
United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14642-0001
United States, Ohio
Gabrail Cancer Center
Canton, Ohio, United States, 44718
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Ohio State University Medical Center - James Cancer Hospital
Columbus, Ohio, United States, 43210
United States, Texas
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Canada, Ontario
Hamilton Health Sciences - McMaster Hospital
Hamilton, Ontario, Canada, L8N 3Z5
UHN - Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M6
Canada, Quebec
Hopital Charles Lemoyne
Greenfield Park, Quebec, Canada, J4V 2H1
Hopital Maisonneuve-Rosemont
Montreal, Quebec, Canada, H1T 2M4
Hopital Notre-Dame du CHUM
Montreal, Quebec, Canada, H2L 4M1
Sir Mortimer Davis-Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Universite de Sherbrooke, Service d'hematologie
Sherbrooke, Quebec, Canada, J1H 5N4
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: NCT00374296     History of Changes
Other Study ID Numbers: 0103-007
Study First Received: September 7, 2006
Last Updated: October 23, 2013
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by MethylGene Inc.:
Leukemia
MDS
Phase II
Acute Myelogenous Leukemia (AML)
High Risk Myelodysplastic Syndromes (MDS)

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Myelodysplastic Syndromes
Preleukemia
Acute Disease
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Disease Attributes
Pathologic Processes
N-(2-aminophenyl)-4-((4-pyridin-3-ylpyrimidin-2-ylamino)methyl)benzamide
Histone Deacetylase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 20, 2014