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

Phase 2

Terminated

• Conditions: Myelogenous Leukemia, Acute; Myelodysplastic Syndromes
• Interventions: Drug: MGCD0103

• Registration Number: NCT00374296
• Lead Sponsor: Mirati Therapeutics Inc.

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 syndrome or adults with relapsed/refractory disease.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2006-09-07
• Study First Submitted QC: 2006-09-07
• Study First Posted: 2006-09-11
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Status Verified: 2015-06
• Disposition First Submitted: 2015-06-04
• Disposition First Submitted QC: 2015-06-04
• Last Update Submitted: 2015-06-04
• Disposition First Posted: 2015-07-01
• Last Update Posted: 2015-07-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 35

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
2	MGCD0103	Relapsed/Refractory Arm

Primary Outcome Measures

Name	Time	Method
Safety and tolerability	1 year (anticipated
Response rate	1 year (anticipated)

Secondary Outcome Measures

Name	Time	Method
Progression-free survival	1 year (anticipated)
Duration of objective response	1 year (anticipated)
Pharmacokinetics	1 year (anticipated)
Pharmacodynamics	1 year (anticipated)

Trial Locations

Locations (13)

Universite de Sherbrooke, Service d'hematologie; 🇨🇦 Sherbrooke, Quebec, Canada

Veterans Affairs Medical Center; 🇺🇸 Kansas City, Missouri, United States

Hopital Maisonneuve-Rosemont; 🇨🇦 Montreal, Quebec, Canada

Sir Mortimer Davis-Jewish General Hospital; 🇨🇦 Montreal, Quebec, Canada

Gabrail Cancer Center; 🇺🇸 Canton, Ohio, United States

UHN - Princess Margaret Hospital; 🇨🇦 Toronto, Ontario, Canada

Hopital Notre-Dame du CHUM; 🇨🇦 Montreal, Quebec, Canada

University of Rochester Medical Center; 🇺🇸 Rochester, New York, United States

Hopital Charles Lemoyne; 🇨🇦 Greenfield Park, Quebec, Canada

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

Hamilton Health Sciences - McMaster Hospital; 🇨🇦 Hamilton, Ontario, Canada

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Ohio State University Medical Center - James Cancer Hospital; 🇺🇸 Columbus, Ohio, United States