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

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

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.

Study Overview

• Status: Terminated
• Conditions: Myelodysplastic Syndromes; Myelogenous Leukemia, Acute
• Intervention / Treatment: Drug: MGCD0103

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8N 3Z5
      • Hamilton Health Sciences - McMaster Hospital
    • Toronto, Ontario, Canada, M5G 2M6
      • UHN - Princess Margaret Hospital
  • Quebec
    • Greenfield Park, Quebec, Canada, J4V 2H1
      • Hopital Charles LeMoyne
    • Montreal, Quebec, Canada, H1T 2M4
      • Hopital Maisonneuve-Rosemont
    • Montreal, Quebec, Canada, H2L 4M1
      • Hopital Notre-Dame du CHUM
    • Montreal, Quebec, Canada, H3T 1E2
      • Sir Mortimer Davis-Jewish General Hospital
    • Sherbrooke, Quebec, Canada, J1H 5N4
      • Universite de Sherbrooke, Service d'hematologie
• United States
  • Missouri
    • Kansas City, Missouri, United States, 64128
      • Veterans Affairs Medical Center
  • New York
    • Rochester, New York, United States, 14642-0001
      • University of Rochester Medical Center
  • Ohio
    • Canton, Ohio, United States, 44718
      • Gabrail Cancer Center
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Columbus, Ohio, United States, 43210
      • Ohio State University Medical Center - James Cancer Hospital
  • Texas
    • Houston, Texas, United States, 77030
      • MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 1; Elderly (≥65 years) untreated arm
Experimental: 2; Relapsed/Refractory Arm	Drug: MGCD0103; MGCD0103 administered orally three-times per week

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Response rate	1 year (anticipated)
Safety and tolerability	1 year (anticipated

Secondary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetics	1 year (anticipated)
Progression-free survival	1 year (anticipated)
Duration of objective response	1 year (anticipated)
Pharmacodynamics	1 year (anticipated)

Collaborators and Investigators

• Sponsor: Mirati Therapeutics Inc.
• Investigators: Study Director: Gregory Reid, MSc, MBA, MethylGene Inc.

Study record dates

Study Major Dates

• Study Start: September 1, 2006
• Primary Completion (Actual): September 1, 2008
• Study Completion (Actual): September 1, 2008

Study Registration Dates

• First Submitted: September 7, 2006
• First Submitted That Met QC Criteria: September 7, 2006
• First Posted (Estimate): September 11, 2006

Study Record Updates

• Last Update Posted (Estimate): July 1, 2015
• Last Update Submitted That Met QC Criteria: June 4, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: Leukemia; MDS; Phase II; Acute Myelogenous Leukemia (AML); High Risk Myelodysplastic Syndromes (MDS)
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Bone Marrow Diseases; Hematologic Diseases; Precancerous Conditions; Myelodysplastic Syndromes; Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Preleukemia; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Histone Deacetylase Inhibitors; Mocetinostat
• Other Study ID Numbers: 0103-007