NCT00374296

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2006

Geographic Reach
2 countries

13 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

September 7, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 11, 2006

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

July 1, 2015

Status Verified

June 1, 2015

Enrollment Period

2 years

First QC Date

September 7, 2006

Last Update Submit

June 4, 2015

Conditions

Myelogenous Leukemia, AcuteMyelodysplastic Syndromes

Keywords

LeukemiaMDSPhase IIAcute Myelogenous Leukemia (AML)High Risk Myelodysplastic Syndromes (MDS)

Outcome Measures

Primary Outcomes (2)

  • Safety and tolerability

    1 year (anticipated

  • Response rate

    1 year (anticipated)

Secondary Outcomes (4)

  • Progression-free survival

    1 year (anticipated)

  • Duration of objective response

    1 year (anticipated)

  • Pharmacokinetics

    1 year (anticipated)

  • Pharmacodynamics

    1 year (anticipated)

Study Arms (2)

1

NO INTERVENTION

Elderly (≥65 years) untreated arm

2

EXPERIMENTAL

Relapsed/Refractory Arm

Drug: MGCD0103

Interventions

MGCD0103DRUG

MGCD0103 administered orally three-times per week

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Veterans Affairs Medical Center

Kansas City, Missouri, 64128, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642-0001, United States

Location

Gabrail Cancer Center

Canton, Ohio, 44718, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Ohio State University Medical Center - James Cancer Hospital

Columbus, Ohio, 43210, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Hamilton Health Sciences - McMaster Hospital

Hamilton, Ontario, L8N 3Z5, Canada

Location

UHN - Princess Margaret Hospital

Toronto, Ontario, M5G 2M6, Canada

Location

Hopital Charles Lemoyne

Greenfield Park, Quebec, J4V 2H1, Canada

Location

Hopital Maisonneuve-Rosemont

Montreal, Quebec, H1T 2M4, Canada

Location

Hopital Notre-Dame du CHUM

Montreal, Quebec, H2L 4M1, Canada

Location

Sir Mortimer Davis-Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

Universite de Sherbrooke, Service d'hematologie

Sherbrooke, Quebec, J1H 5N4, Canada

Location

MeSH Terms

Conditions

Leukemia, Myeloid, AcuteMyelodysplastic SyndromesLeukemia

Interventions

mocetinostat

Condition Hierarchy (Ancestors)

Leukemia, MyeloidNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesBone Marrow Diseases

Study Officials

  • Gregory Reid, MSc, MBA

    MethylGene Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 7, 2006

First Posted

September 11, 2006

Study Start

September 1, 2006

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

July 1, 2015

Record last verified: 2015-06

Locations

CA(7)US(6)