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

Primary Purpose

AML

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Obatoclax
Sponsored by
Gemin X
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for AML focused on measuring AML, obatoclax

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Northwestern University
  • The University of Iowa
  • University of Kansas Medical Center Research Institute
  • Dana Farber Cancer Institute
  • St. Joseph Mercy Hospital
  • University of Michigan Health System
  • Michigan State University - Breslin Cancer Center
  • St. Vincent's Comprehensive Cancer Center
  • Legacy Emanuel Hospital & Health Center
  • Penn State Hershey Cancer Institute-Clinical Trials Office
  • MD Anderson Cancer Center
  • Benaroya Research Institute at Virginia Mason
  • Princess Margaret Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental

Arm Description

In the Pilot Schedule portion of the study 3 hour vs 24 hour infusion schedules of obatoclax.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 23, 2008
Last Updated
August 16, 2013
Sponsor
Gemin X
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1. Study Identification

Unique Protocol Identification Number
NCT00684918
Brief Title
Study of Obatoclax in Previously Untreated Acute Myeloid Leukemia (AML)
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 Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gemin X

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
AML
Keywords
AML, obatoclax

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental
Arm Type
Experimental
Arm Description
In the Pilot Schedule portion of the study 3 hour vs 24 hour infusion schedules of obatoclax.
Intervention Type
Drug
Intervention Name(s)
Obatoclax
Other Intervention Name(s)
GX15-070MS
Intervention Description
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.
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: Total bilirubin < or = 2 mg/dL unless resulting from hemolysis, Aspartate transaminase (AST [SGOT])/alanine transaminase (ALT [SGPT]) < or = 2.5 x institutional ULN 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean Viallet, MD
Organizational Affiliation
Gemin X Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
The University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
University of Kansas Medical Center Research Institute
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
St. Joseph Mercy Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
University of Michigan Health System
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Michigan State University - Breslin Cancer Center
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48910
Country
United States
Facility Name
St. Vincent's Comprehensive Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10011
Country
United States
Facility Name
Legacy Emanuel Hospital & Health Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Penn State Hershey Cancer Institute-Clinical Trials Office
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Benaroya Research Institute at Virginia Mason
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
25285531
Citation
Schimmer AD, Raza A, Carter TH, Claxton D, Erba H, DeAngelo DJ, Tallman MS, Goard C, Borthakur G. A multicenter phase I/II study of obatoclax mesylate administered as a 3- or 24-hour infusion in older patients with previously untreated acute myeloid leukemia. PLoS One. 2014 Oct 6;9(10):e108694. doi: 10.1371/journal.pone.0108694. eCollection 2014.
Results Reference
derived

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

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