MGCD0103 in Elderly Patients With Previously Untreated AML/High Risk MDS or Adults With Relapsed/Refractory Disease
NCT ID: NCT00374296
Last Updated: 2015-07-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
35 participants
INTERVENTIONAL
2006-09-30
2008-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
Elderly (≥65 years) untreated arm
No interventions assigned to this group
2
Relapsed/Refractory Arm
MGCD0103
MGCD0103 administered orally three-times per week
Interventions
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MGCD0103
MGCD0103 administered orally three-times per week
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Mirati Therapeutics Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Gregory Reid, MSc, MBA
Role: STUDY_DIRECTOR
MethylGene Inc.
Locations
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Veterans Affairs Medical Center
Kansas City, Missouri, United States
University of Rochester Medical Center
Rochester, New York, United States
Gabrail Cancer Center
Canton, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Ohio State University Medical Center - James Cancer Hospital
Columbus, Ohio, United States
MD Anderson Cancer Center
Houston, Texas, United States
Hamilton Health Sciences - McMaster Hospital
Hamilton, Ontario, Canada
UHN - Princess Margaret Hospital
Toronto, Ontario, Canada
Hopital Charles Lemoyne
Greenfield Park, Quebec, Canada
Hopital Maisonneuve-Rosemont
Montreal, Quebec, Canada
Hopital Notre-Dame du CHUM
Montreal, Quebec, Canada
Sir Mortimer Davis-Jewish General Hospital
Montreal, Quebec, Canada
Universite de Sherbrooke, Service d'hematologie
Sherbrooke, Quebec, Canada
Countries
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Other Identifiers
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0103-007
Identifier Type: -
Identifier Source: org_study_id
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