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

Myelodysplastic Syndromes Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00374296
• Other study ID #: 0103-007
• Status: Terminated
• Phase: Phase 2
• First received: September 7, 2006
• Last updated: June 4, 2015
• Start date: September 2006
• Est. completion date: September 2008

Study information

• Verified date: June 2015
• Source: Mirati Therapeutics Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 35
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Myelodysplastic Syndromes
• Myelogenous Leukemia, Acute
• Preleukemia

Intervention

Drug:
• MGCD0103
MGCD0103 administered orally three-times per week

Locations

Country	Name	City	State
Canada	Hopital Charles Lemoyne	Greenfield Park	Quebec
Canada	Hamilton Health Sciences - McMaster Hospital	Hamilton	Ontario
Canada	Hopital Maisonneuve-Rosemont	Montreal	Quebec
Canada	Hopital Notre-Dame du CHUM	Montreal	Quebec
Canada	Sir Mortimer Davis-Jewish General Hospital	Montreal	Quebec
Canada	Universite de Sherbrooke, Service d'hematologie	Sherbrooke	Quebec
Canada	UHN - Princess Margaret Hospital	Toronto	Ontario
United States	Gabrail Cancer Center	Canton	Ohio
United States	Cleveland Clinic	Cleveland	Ohio
United States	Ohio State University Medical Center - James Cancer Hospital	Columbus	Ohio
United States	MD Anderson Cancer Center	Houston	Texas
United States	Veterans Affairs Medical Center	Kansas City	Missouri
United States	University of Rochester Medical Center	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
Mirati Therapeutics Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability		1 year (anticipated	Yes
Primary	Response rate		1 year (anticipated)	No
Secondary	Progression-free survival		1 year (anticipated)	Yes
Secondary	Duration of objective response		1 year (anticipated)	No
Secondary	Pharmacokinetics		1 year (anticipated)	No
Secondary	Pharmacodynamics		1 year (anticipated)	No