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

Mirati Therapeutics

Status and phase

Terminated

Phase 2

Conditions

Myelodysplastic Syndromes

Myelogenous Leukemia, Acute

Treatments

Drug: MGCD0103

Study type

Interventional

Funder types

Industry

Identifiers

NCT00374296

0103-007

Details and patient eligibility

About

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.

Enrollment

35 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.