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

• Sponsor: Mirati Therapeutics Inc. (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT00374296
• Collaborator: (none)
• Enrollment: 35
• Locations: 13
• Arms: 2
• Duration (Months): 24
• Patients Per Site: 2.7
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myelogenous Leukemia, Acute; Myelodysplastic Syndromes	Drug: MGCD0103	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 35 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: Sep 1, 2006
• Actual Primary Completion Date: Sep 1, 2008
• Actual Study Completion Date: Sep 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: 1 Elderly (≥65 years) untreated arm
Experimental: 2 Relapsed/Refractory Arm	Drug: MGCD0103; MGCD0103 administered orally three-times per week

Outcome Measures

Primary Outcome Measures

1. Safety and tolerability [1 year (anticipated]

2. Response rate [1 year (anticipated)]

Secondary Outcome Measures

1. Progression-free survival [1 year (anticipated)]

2. Duration of objective response [1 year (anticipated)]

3. Pharmacokinetics [1 year (anticipated)]

4. Pharmacodynamics [1 year (anticipated)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Veterans Affairs Medical Center	Kansas City	Missouri	United States	64128
2	University of Rochester Medical Center	Rochester	New York	United States	14642-0001
3	Gabrail Cancer Center	Canton	Ohio	United States	44718
4	Cleveland Clinic	Cleveland	Ohio	United States	44195
5	Ohio State University Medical Center - James Cancer Hospital	Columbus	Ohio	United States	43210
6	MD Anderson Cancer Center	Houston	Texas	United States	77030
7	Hamilton Health Sciences - McMaster Hospital	Hamilton	Ontario	Canada	L8N 3Z5
8	UHN - Princess Margaret Hospital	Toronto	Ontario	Canada	M5G 2M6
9	Hopital Charles Lemoyne	Greenfield Park	Quebec	Canada	J4V 2H1
10	Hopital Maisonneuve-Rosemont	Montreal	Quebec	Canada	H1T 2M4
11	Hopital Notre-Dame du CHUM	Montreal	Quebec	Canada	H2L 4M1
12	Sir Mortimer Davis-Jewish General Hospital	Montreal	Quebec	Canada	H3T 1E2
13	Universite de Sherbrooke, Service d'hematologie	Sherbrooke	Quebec	Canada	J1H 5N4

Sponsors and Collaborators

• Mirati Therapeutics Inc.

Investigators

• Study Director: Gregory Reid, MSc, MBA, MethylGene Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mirati Therapeutics Inc.
• ClinicalTrials.gov Identifier: NCT00374296
• Other Study ID Numbers: 0103-007
• First Posted: Sep 11, 2006
• Last Update Posted: Jul 1, 2015
• Last Verified: Jun 1, 2015

• Keywords provided by Mirati Therapeutics Inc.: Leukemia; MDS; Phase II; Acute Myelogenous Leukemia (AML); High Risk Myelodysplastic Syndromes (MDS)
• Additional relevant MeSH terms: Leukemia; Preleukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute; Myelodysplastic Syndromes; Mocetinostat

Study Results

No Results Posted as of Jul 1, 2015