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

• Status: Terminated
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mirati Therapeutics Inc.
• Treatments: Mocetinostat

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.