NCT00324194

Brief Summary

In this study, MGCD0103, a new anticancer drug under investigation, is given twice weekly to patients with leukemia or myelodysplastic syndromes.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at P25-P50 for phase_1 leukemia

Timeline
Completed

Started Feb 2005

Geographic Reach
2 countries

4 active sites

Status
completed

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

February 1, 2005

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

May 8, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 10, 2006

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

January 8, 2015

Status Verified

January 1, 2015

Enrollment Period

3.1 years

First QC Date

May 8, 2006

Last Update Submit

January 6, 2015

Conditions

LeukemiaMyelodysplastic Syndromes

Keywords

LeukemiaMyelodysplastic SyndromesPhase I

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability.

    1 year (anticipated)

Secondary Outcomes (4)

  • Clinical response.

    1 year (anticipated)

  • Dose limiting toxicities

    1 year (anticipated)

  • Pharmacokinetics

    1 year (anticipated)

  • Pharmacodynamics (histone acetylation, biomarkers)

    1 year (anticipated)

Study Arms (1)

1

EXPERIMENTAL

MGCD0103 oral dose 2 times per week.

Drug: MGCD0103

Interventions

MGCD0103DRUG

MGCD0103 oral dose given 2 times per week.

1

Eligibility Criteria

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

You may qualify if:

  • Patients must have a diagnosis of one of the following:
  • relapsed or refractory AML or ALL that has failed to respond to standard therapy, has progressed despite standard therapy.
  • relapsed or refractory Myelodysplastic Syndromes including CMML (chronic myelomonocytic leukemia) or other myeloproliferative disorders provided there is an MDS component.
  • previously untreated AML or Myelodysplastic Syndromes in patients \>60 years of age who refused or are not candidates for induction chemotherapy
  • Patients with relapsed or refractory CML that has failed to respond to imatinib therapy or standard therapy, has progressed despite standard therapy, or for which no standard therapy exists.
  • ECOG performance status of 0, 1, or 2.
  • Age ≥18 years.
  • Laboratory requirements.
  • Patients or their legal representative must be able to read, understand, and sign a written informed consent (approved by the IRB/EC) prior to study entry.

You may not qualify if:

  • Patients with other active malignancy except basal cell carcinoma or cervical intraepithelial neoplasia (CIN / cervical in situ).
  • Patients with suspicion of CNS involvement (tests are not required to rule out CNS involvement in the absence of signs or symptoms).
  • Pregnant or lactating women. Women of child-bearing potential must have a negative serum pregnancy test documented within 7 days prior to registration on study.
  • Patients and their partners, if either are of childbearing potential, not using adequate birth control measures throughout the course of the study. Both men and women enrolled on study must agree to use a medically acceptable effective form of contraception during the study and for 90 days following the last dose of study medication. An effective form of contraception is an oral contraceptive or a double barrier method, such as condom with diaphragm.
  • Patients with serious illnesses, medical conditions, or other medical history, including laboratory results, which, in the investigator's opinion, would be likely to interfere with a patient's participation in the study, or with the interpretation of the results.
  • Patients who have been treated with any investigational drug within 30 days prior to study initiation (an investigational drug is one for which there is no approved indication), or who are receiving concurrent treatment with other experimental drugs or anti-cancer therapy.
  • Known hypersensitivity to any of the components of MGCD0103.
  • Known HIV or Hepatitis B or C (tests do not need to be performed to rule out any of these infections).
  • Any psychiatric illness/social situations that would, in the judgment of the investigator, limit compliance with study requirements.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Lee Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Sir Mortimer Davis Jewish General Hospital

Montreal, Quebec, Canada

Location

MeSH Terms

Conditions

LeukemiaMyelodysplastic Syndromes

Interventions

mocetinostat

Condition Hierarchy (Ancestors)

Neoplasms 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 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 8, 2006

First Posted

May 10, 2006

Study Start

February 1, 2005

Primary Completion

March 1, 2008

Study Completion

August 1, 2008

Last Updated

January 8, 2015

Record last verified: 2015-01

Locations

CA(1)US(3)