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
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: 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 Notre-Dame du CHUM
Montreal, Quebec, Canada, H2L 4M1
Hopital Maisonneuve-Rosemont
Montreal, Quebec, Canada, H1T 2M4
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
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Preleukemia
Syndrome
Bone Marrow Diseases
Disease
Hematologic Diseases
Neoplasms
Neoplasms by Histologic Type
Pathologic Processes
Precancerous Conditions

ClinicalTrials.gov processed this record on October 23, 2014