Know Cancer

or
forgot password

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

Thank you

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 Center Houston, Texas  77030-4096
University of Rochester Medical Center Rochester, New York  14642
Cleveland Clinic Cleveland, Ohio  44195
Gabrail Cancer Center Canton, Ohio  44718
Veterans Affairs Medical Center Kansas City, Missouri  64128
Ohio State University Medical Center - James Cancer Hospital Columbus, Ohio  43210