Phase 2 Study of Azacitidine (Vidaza) vs MGCD0103 vs Combination in Elderly Subjects With Newly Diagnosed Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome (MDS)

NCT00666497 | Terminated Phase 2 DMC

• 1 other identifier: 103 PH GL 2007 CL003
• Study Type: interventional
• Target: 6
• Locations: 3 countries
• Sites: 8

Brief Summary

The purpose of the study is to determine how effective azacitidine, MGCD0103, and the combination of azacitidine and MGCD0103 are in treating AML or MDS in people over 60 years of age.

Conditions

Acute Myeloid Leukemia (AML); Myelodysplastic Syndrome (MDS)

Keywords

Acute Myeloid Leukemia; Myelodysplastic Syndrome; Azacitidine; Vidaza; MGCD0103; Histone deacetylase inhibitor; DNA methyltransferase inhibitor; Epigenetic Therapy

Outcome Measures

Primary Outcomes (1)

• Overall response rate as assessed using IWG criteria for AML and MDS

  After 45, 90, 135, and 180 subjects are enrolled and evaluated for response to treatment

Secondary Outcomes (1)

• Duration of response; Time to progression; Progression-free survival; RBC transfusion independence; Hematologic improvement; Quality of life; Safety profile; and Pharmacokinetics of azacitidine and MGCD0103

  After 45, 90, 135, and 180 subjects are enrolled and evaluated for response to treatment

Study Arms (3)

A

EXPERIMENTAL

Azacitidine

Drug: Azacitidine

B

EXPERIMENTAL

MGCD0103

Drug: MGCD0103

C

EXPERIMENTAL

Azacitidine + MGCD0103

Drug: Azacitidine; Drug: MGCD0103

Interventions

Azacitidine DRUG

75 mg/m2/day for 5 days, subcutaneous (SC) injection, Days 1 - 5 of every 28-day cycle

Also known as: Vidaza

A; C

MGCD0103 DRUG

90 mg, oral (PO) administration, 3 times per week for 12 doses, 28-day cycle

B

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to provide written informed consent, and be willing and able to comply with all the study procedures
• Must be 60 years of age or older
• Must have a pathologic confirmation of newly diagnosed (de novo or untreated secondary) AML or newly diagnosed Int-2 or high-risk MDS (IPSS classification) according to WHO criteria
• Must have a Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
• Must have adequate organ function, including total bilirubin ≤ 1.5 x upper limit of normal (ULN); AST \& ALT ≤ 2.5 x ULN; and serum creatinine ≤ 2.0 x ULN.

You may not qualify if:

• Considered fit for intensive chemotherapy and opt to be treated with intensive chemotherapy
• Prior transplantation or any prior anticancer therapy (standard or investigational, including chemotherapy, treatment with HDAC inhibitors, or combination HDAC and azacitidine) administered to treat AML or MDS.
• Clinical evidence of central nervous system (CNS) involvement by leukemia
• A diagnosis of promyelocytic leukemia
• Previous or concurrent malignancy except adequately treated basal cell or squamous cell skin cancer; in situ carcinoma of the cervix, or other solid tumor treated curatively, and without evidence of recurrence for at least 3 years prior to study entry
• Active and uncontrolled clinically significant infection
• Known positive serology for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV Ab) or human immunodeficiency virus (HIV)
• Less than 4 weeks elapsed since any major surgery
• Any prior or active disease that may interfere with the procedures or evaluations to be conducted in the study

Sponsors & Collaborators

• Mirati Therapeutics Inc.: lead

Study Sites (8)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Diamond Centre, Leukemia/BMT Program of BC

Vancouver, British Columbia, V5Z 4E3, Canada

Location

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

Location

University Hospital

Birmingham, B15 2TH, United Kingdom

Location

Royal Bournemouth Hospital

Bournemouth, BH7 7DW, United Kingdom

Location

St. Bartholomews Hospital

London, EC1A 7BE, United Kingdom

Location

Kings College Hospital

London, SE5 9RS, United Kingdom

Location

John Radcliffe Hospital

Oxford, OX3 9DU, United Kingdom

Location

Related Links

• The Leukemia \& Lymphoma Society
• The Myelodysplastic Syndromes Foundation
• Leukemia Research Foundation

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Myelodysplastic Syndromes

Interventions

Azacitidine; mocetinostat

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Gregory Reid, MSc, MBA

  MethylGene Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2008
• First Posted: April 25, 2008
• Study Start: June 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: May 8, 2015

Record last verified: 2015-04

Locations

GB (5); US (1); CA (2)