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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Myelogenous Leukemia, Acute, Myelodysplastic Syndromes

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety and tolerability

Outcome Time Frame:

1 year (anticipated

Safety Issue:

Yes

Principal Investigator

Gregory Reid, MSc, MBA

Investigator Role:

Study Director

Investigator Affiliation:

MethylGene Inc.

Authority:

United States: Food and Drug Administration

Study ID:

0103-007

NCT ID:

NCT00374296

Start Date:

September 2006

Completion Date:

September 2008

Related Keywords:

  • Myelogenous Leukemia, Acute
  • Myelodysplastic Syndromes
  • Leukemia
  • MDS
  • Phase II
  • Acute Myelogenous Leukemia (AML)
  • High Risk Myelodysplastic Syndromes (MDS)
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid
  • Myelodysplastic Syndromes
  • Preleukemia
  • Acute Disease

Name

Location

MD Anderson Cancer CenterHouston, Texas  77030-4096
University of Rochester Medical CenterRochester, New York  14642
Cleveland ClinicCleveland, Ohio  44195
Gabrail Cancer CenterCanton, Ohio  44718
Veterans Affairs Medical CenterKansas City, Missouri  64128
Ohio State University Medical Center - James Cancer HospitalColumbus, Ohio  43210