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

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

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00374296

Enrollment

Registered

2006-09-11

Start date

2006-09-30

Completion date

2008-09-30

Last updated

2015-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myelodysplastic Syndromes, Myelogenous Leukemia, Acute

Keywords

Leukemia, MDS, Phase II, Acute Myelogenous Leukemia (AML), High Risk Myelodysplastic Syndromes (MDS)

Brief 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.

Interventions

DRUGMGCD0103

MGCD0103 administered orally three-times per week

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame
Safety and tolerability	1 year (anticipated
Response rate	1 year (anticipated)

Secondary

Measure	Time frame
Progression-free survival	1 year (anticipated)
Duration of objective response	1 year (anticipated)
Pharmacokinetics	1 year (anticipated)
Pharmacodynamics	1 year (anticipated)

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026