Study of Obatoclax in Previously Untreated Acute Myeloid Leukemia (AML)

August 16, 2013 updated by: Gemin X

A Multicenter, Open-Label, 2-Stage, Phase II Study of Single-Agent Obatoclax Mesylate Administered For Three Consecutive Days Every 2 Weeks to Older Patients With Previously Untreated Acute Myeloid Leukemia (AML)

This protocol will evaluate the efficacy of obatoclax in older patients with previously untreated AML.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The Pilot Safety portion of the study will evaluate the safety of obatoclax administered by a 3 hour infusion for 3 days in a row. The Pilot Schedule portion of the study will randomize 16 patients in to one of two cohorts: 1) patients receiving obatoclax administered by a 3 hour infusion for 3 days in a row or 2) patients receiving obatoclax administered by a 24 hour infusion for 3 days in a row. The schedule with the best overall efficacy and safety in the Pilot Schedule portion of the study will then be utilized in the Phase II portion of the study.

Study Type

Interventional

Enrollment (Actual)

18

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
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Hospital
  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • The University of Iowa
    • Kansas
      • Westwood, Kansas, United States, 66205
        • University of Kansas Medical Center Research Institute
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Dana Farber Cancer Institute
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Health System
      • Ann Arbor, Michigan, United States, 48106
        • St. Joseph Mercy Hospital
      • Lansing, Michigan, United States, 48910
        • Michigan State University - Breslin Cancer Center
    • New York
      • New York, New York, United States, 10011
        • St. Vincent's Comprehensive Cancer Center
    • Oregon
      • Portland, Oregon, United States, 97210
        • Legacy Emanuel Hospital & Health Center
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Hershey Cancer Institute-Clinical Trials Office
    • Texas
      • Houston, Texas, United States, 77030
        • MD Anderson Cancer Center
    • Washington
      • Seattle, Washington, United States, 98101
        • Benaroya Research Institute at Virginia Mason

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

70 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically or cytologically confirmed AML
  • No prior chemotherapy for AML (with the exception that the patients enrolled in the Pilot Safety evaluation may have had 1 prior therapy)
  • Age ≥70 years
  • Eastern Cooperative Oncology Group (ECOG) Performance Status ≤2

  • Patients must have normal organ function as defined below:

    1. Total bilirubin < or = 2 mg/dL unless resulting from hemolysis,
    2. Aspartate transaminase (AST [SGOT])/alanine transaminase (ALT [SGPT]) < or = 2.5 x institutional ULN
    3. Creatinine within normal institutional limits, OR creatinine clearance > or = 50 mL/min/1.73 meters squared for patients with creatinine levels above institutional ULN

Exclusion Criteria:

  • Patients who have received or are receiving any other investigational or commercial agents or therapies administered with the intent to treat their malignancy (with the exception that the patients enrolled in the pilot safety evaluation may have had 1 prior therapy)
  • patients with history of allergic reactions attributed to components of the formulated product (PEG300 and polysorbate 20)
  • patients with history of seizure disorders or central nervous system leukemia
  • patients with uncontrolled, intercurrent illness including, but not limited to, symptomatic neurological illness; active, uncontrolled, systemic infection considered opportunistic, life-threatening, or clinically significant at the time of treatment; symptomatic congestive heart failure; unstable angina pectoris; cardiac arrhythmia; significant pulmonary disease or hypoxia; or psychiatric illness/social situations that would limit compliance with study requirements
  • Human immunodeficiency virus (HIV)-positive patients receiving combination anti-retroviral therapy

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
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Experimental
In the Pilot Schedule portion of the study 3 hour vs 24 hour infusion schedules of obatoclax.
Drug: Obatoclax
A 3-hour IV infusion for 3 consecutive days or a 24-hour infusion for 3 consecutive days every 2 weeks for up to 6 cycles.
Other Names:
  • GX15-070MS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Determine the rate of morphologic CR after treatment in the obatoclax single-agent therapy in older patients with previously untreated AML.
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

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

Sponsor

Gemin X

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.

General Publications

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

April 1, 2008

Primary Completion (ACTUAL)

August 1, 2009

Study Completion (ACTUAL)

December 1, 2009

Study Registration Dates

First Submitted

May 23, 2008

First Submitted That Met QC Criteria

May 27, 2008

First Posted (ESTIMATE)

May 28, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

August 26, 2013

Last Update Submitted That Met QC Criteria

August 16, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GEM016

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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