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

Primary Purpose

Myelogenous Leukemia, Acute, Myelodysplastic Syndromes

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
MGCD0103
Sponsored by
Mirati Therapeutics Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myelogenous Leukemia, Acute focused on measuring Leukemia, MDS, Phase II, Acute Myelogenous Leukemia (AML), High Risk Myelodysplastic Syndromes (MDS)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Veterans Affairs Medical Center
  • University of Rochester Medical Center
  • Gabrail Cancer Center
  • Cleveland Clinic
  • Ohio State University Medical Center - James Cancer Hospital
  • MD Anderson Cancer Center
  • Hamilton Health Sciences - McMaster Hospital
  • UHN - Princess Margaret Hospital
  • Hopital Charles Lemoyne
  • Hopital Maisonneuve-Rosemont
  • Hopital Notre-Dame du CHUM
  • Sir Mortimer Davis-Jewish General Hospital
  • Universite de Sherbrooke, Service d'hematologie

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

1

2

Arm Description

Elderly (≥65 years) untreated arm

Relapsed/Refractory Arm

Outcomes

Primary Outcome Measures

Safety and tolerability
Response rate

Secondary Outcome Measures

Progression-free survival
Duration of objective response
Pharmacokinetics
Pharmacodynamics

Full Information

First Posted
September 7, 2006
Last Updated
June 4, 2015
Sponsor
Mirati Therapeutics Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00374296
Brief Title
MGCD0103 in Elderly Patients With Previously Untreated AML/High Risk MDS or Adults With Relapsed/Refractory Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Terminated
Why Stopped
The Clinical Development Program for MGCD0103 is being re-evaluated
Study Start Date
September 2006 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mirati Therapeutics Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelogenous Leukemia, Acute, Myelodysplastic Syndromes
Keywords
Leukemia, MDS, Phase II, Acute Myelogenous Leukemia (AML), High Risk Myelodysplastic Syndromes (MDS)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
No Intervention
Arm Description
Elderly (≥65 years) untreated arm
Arm Title
2
Arm Type
Experimental
Arm Description
Relapsed/Refractory Arm
Intervention Type
Drug
Intervention Name(s)
MGCD0103
Intervention Description
MGCD0103 administered orally three-times per week
Primary Outcome Measure Information:
Title
Safety and tolerability
Time Frame
1 year (anticipated
Title
Response rate
Time Frame
1 year (anticipated)
Secondary Outcome Measure Information:
Title
Progression-free survival
Time Frame
1 year (anticipated)
Title
Duration of objective response
Time Frame
1 year (anticipated)
Title
Pharmacokinetics
Time Frame
1 year (anticipated)
Title
Pharmacodynamics
Time Frame
1 year (anticipated)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory Reid, MSc, MBA
Organizational Affiliation
MethylGene Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Veterans Affairs Medical Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64128
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642-0001
Country
United States
Facility Name
Gabrail Cancer Center
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Ohio State University Medical Center - James Cancer Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Hamilton Health Sciences - McMaster Hospital
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
Facility Name
UHN - Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M6
Country
Canada
Facility Name
Hopital Charles Lemoyne
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2H1
Country
Canada
Facility Name
Hopital Maisonneuve-Rosemont
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
Hopital Notre-Dame du CHUM
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada
Facility Name
Sir Mortimer Davis-Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
Universite de Sherbrooke, Service d'hematologie
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

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