Status:
TERMINATED
MGCD0103 in Elderly Patients With Previously Untreated AML/High Risk MDS or Adults With Relapsed/Refractory Disease
Lead Sponsor:
Mirati Therapeutics Inc.
Conditions:
Myelogenous Leukemia, Acute
Myelodysplastic Syndromes
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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 syn...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00374296
Start Date
September 1 2006
End Date
September 1 2008
Last Update
July 1 2015
Active Locations (13)
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1
Veterans Affairs Medical Center
Kansas City, Missouri, United States, 64128
2
University of Rochester Medical Center
Rochester, New York, United States, 14642-0001
3
Gabrail Cancer Center
Canton, Ohio, United States, 44718
4
Cleveland Clinic
Cleveland, Ohio, United States, 44195