Study of Obatoclax in Previously Untreated Acute Myeloid Leukemia (AML) - Full Text View

Sponsored by:	Gemin X
Information provided by:	Gemin X
ClinicalTrials.gov Identifier:	NCT00684918

Purpose

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

Condition	Intervention	Phase
AML	Drug: Obatoclax	Phase II

Drug Information available for: Obatoclax mesylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Parallel Assignment
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)

Further study details as provided by Gemin X:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	106
Study Start Date:	April 2008
Estimated Study Completion Date:	August 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

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.

Eligibility

Ages Eligible for Study:	70 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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:
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00684918

Locations

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

Sponsors and Collaborators

Gemin X

Investigators

Study Director:

Jean Viallet, MD

Gemin X Pharmaceuticals

More Information

No publications provided

Responsible Party:	Gemin X, Pharmaceuticals ( Jean Viallet, MD )
Study ID Numbers:	GEM016
Study First Received:	May 23, 2008
Last Updated:	February 16, 2009
ClinicalTrials.gov Identifier:	NCT00684918 History of Changes
Health Authority:	United States: Food and Drug Administration; Canada: Health Canada

Keywords provided by Gemin X:

AML, obatoclax

Study placed in the following topic categories:

Leukemia
Acute Myelocytic Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute

Additional relevant MeSH terms:

Leukemia
Neoplasms
Neoplasms by Histologic Type
Leukemia, Myeloid
Leukemia, Myeloid, Acute

ClinicalTrials.gov processed this record on May 07, 2009