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

Sponsor
Gemin X (Industry)
Overall Status
Completed
CT.gov ID
NCT00684918
Collaborator
(none)
18
Enrollment
13
Locations
1
Arm
20
Duration (Months)
1.4
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
18 participants
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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)
Study Start Date :
Apr 1, 2008
Actual Primary Completion Date :
Aug 1, 2009
Actual Study Completion Date :
Dec 1, 2009

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Determine the rate of morphologic CR after treatment in the obatoclax single-agent therapy in older patients with previously untreated AML. [4 weeks]

    Eligibility Criteria

    Criteria

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

    Contacts and Locations

    Locations

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

    Sponsors and Collaborators

    • Gemin X

    Investigators

    • Study Director: Jean Viallet, MD, Gemin X Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Gemin X
    ClinicalTrials.gov Identifier:
    NCT00684918
    Other Study ID Numbers:
    • GEM016
    First Posted:
    May 28, 2008
    Last Update Posted:
    Aug 26, 2013
    Last Verified:
    Aug 1, 2013
    Keywords provided by Gemin X
    AML, obatoclax
    Additional relevant MeSH terms:
    Leukemia, Myeloid, Acute
    Obatoclax

    Study Results

    No Results Posted as of Aug 26, 2013