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

April 22, 2015 updated by: Mirati Therapeutics Inc.

A Phase 2, Randomized, Open-Label Study of Azacitidine (Vidaza) vs MGCD0103 vs Azacitidine in Combination With MGCD0103 for the Treatment of Elderly Subjects With Newly Diagnosed AML or Intermediate-2 or High-Risk MDS

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This randomized, 3-arm Phase 2 study will compare the safety and efficacy of single-agent azacitidine (currently 1 of 3 approved treatments for myelodysplastic syndrome [MDS]) to that of single-agent MGCD0103 and to that of combination therapy with MGCD0103 and azacitidine in elderly patients with acute myelogenous leukemia (AML) or intermediate-2 (Int-2) or high-risk MDS, for whom no standard of care exists. The goal of the study is to determine which of the 3 treatment arms are worthy of further investigation in a subsequent Phase 3 study of elderly subjects with AML or Int-2 or high-risk MDS.

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E3
        • Diamond Centre, Leukemia/BMT Program of BC
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Jewish General Hospital
  • United Kingdom
      • Birmingham, United Kingdom, B15 2TH
        • University Hospital
      • Bournemouth, United Kingdom, BH7 7DW
        • Royal Bournemouth Hospital
      • London, United Kingdom, SE5 9RS
        • Kings College Hospital
      • London, United Kingdom, EC1A 7BE
        • St. Bartholomews Hospital
      • Oxford, United Kingdom, OX3 9DU
        • John Radcliffe Hospital
  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Azacitidine
Drug: Azacitidine
75 mg/m2/day for 5 days, subcutaneous (SC) injection, Days 1 - 5 of every 28-day cycle
Other Names:
  • Vidaza
Experimental: B
MGCD0103
Drug: MGCD0103
90 mg, oral (PO) administration, 3 times per week for 12 doses, 28-day cycle
Drug: MGCD0103
90 mg, oral (PO) administration, 3 times per week for 10 doses, 28-day cycle
Experimental: C
Azacitidine + MGCD0103
Drug: Azacitidine
75 mg/m2/day for 5 days, subcutaneous (SC) injection, Days 1 - 5 of every 28-day cycle
Other Names:
  • Vidaza
Drug: MGCD0103
90 mg, oral (PO) administration, 3 times per week for 12 doses, 28-day cycle
Drug: MGCD0103
90 mg, oral (PO) administration, 3 times per week for 10 doses, 28-day cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall response rate as assessed using IWG criteria for AML and MDS
Time Frame: After 45, 90, 135, and 180 subjects are enrolled and evaluated for response to treatment
After 45, 90, 135, and 180 subjects are enrolled and evaluated for response to treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: After 45, 90, 135, and 180 subjects are enrolled and evaluated for response to treatment
After 45, 90, 135, and 180 subjects are enrolled and evaluated for response to treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mirati Therapeutics Inc.

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

April 1, 2009

Study Registration Dates

First Submitted

April 23, 2008

First Submitted That Met QC Criteria

April 23, 2008

First Posted (Estimate)

April 25, 2008

Study Record Updates

Last Update Posted (Estimate)

May 8, 2015

Last Update Submitted That Met QC Criteria

April 22, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 103 PH GL 2007 CL003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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