Clinical trial NCT00374296: MGCD0103 in Elderly Patients With Previously Untreated AML/High Risk MDS or Adults With Relapsed/Refractory Disease
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Myelogenous Leukemia, Acute
Myelodysplastic Syndromes
Keywords: Leukemia
MDS
Phase II
Acute Myelogenous Leukemia (AML)
High Risk Myelodysplastic Syndromes (MDS)
Lead sponsor: Mirati Therapeutics Inc.
Sponsor class: INDUSTRY
First posted: 2006-09-11
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Safety and tolerability
timeFrame: 1 year (anticipated
measure: Response rate
timeFrame: 1 year (anticipated)
Secondary outcomes:
measure: Progression-free survival
timeFrame: 1 year (anticipated)
measure: Duration of objective response
timeFrame: 1 year (anticipated)
measure: Pharmacokinetics
timeFrame: 1 year (anticipated)
measure: Pharmacodynamics
timeFrame: 1 year (anticipated)
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: Veterans Affairs Medical Center
state: Missouri
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Canton
country: United States
facility: Gabrail Cancer Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: Ohio State University Medical Center - James Cancer Hospital
state: Ohio
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Hamilton
country: Canada
facility: Hamilton Health Sciences - McMaster Hospital
state: Ontario
city: Toronto
country: Canada
facility: UHN - Princess Margaret Hospital
state: Ontario
city: Greenfield Park
country: Canada
facility: Hopital Charles Lemoyne
state: Quebec
city: Montreal
country: Canada
facility: Hopital Maisonneuve-Rosemont
state: Quebec
city: Montreal
country: Canada
facility: Hopital Notre-Dame du CHUM
state: Quebec
city: Montreal
country: Canada
facility: Sir Mortimer Davis-Jewish General Hospital
state: Quebec
city: Sherbrooke
country: Canada
facility: Universite de Sherbrooke, Service d'hematologie
state: Quebec
Study officials:
affiliation: MethylGene Inc.
name: Gregory Reid, MSc, MBA
role: STUDY_DIRECTOR
References: