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

AML Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00684918
• Other study ID #: GEM016
• Status: Completed
• Phase: Phase 2
• First received: May 23, 2008
• Last updated: August 16, 2013
• Start date: April 2008
• Est. completion date: December 2009

Study information

• Verified date: August 2013
• Source: Teva Pharmaceutical Industries
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 70 Years and older

Eligibility

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 Design

Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• AML
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

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.

Locations

Country	Name	City	State
Canada	Princess Margaret Hospital	Toronto	Ontario
United States	St. Joseph Mercy Hospital	Ann Arbor	Michigan
United States	University of Michigan Health System	Ann Arbor	Michigan
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Northwestern University	Chicago	Illinois
United States	Penn State Hershey Cancer Institute-Clinical Trials Office	Hershey	Pennsylvania
United States	MD Anderson Cancer Center	Houston	Texas
United States	The University of Iowa	Iowa City	Iowa
United States	Michigan State University - Breslin Cancer Center	Lansing	Michigan
United States	St. Vincent's Comprehensive Cancer Center	New York	New York
United States	Legacy Emanuel Hospital & Health Center	Portland	Oregon
United States	Benaroya Research Institute at Virginia Mason	Seattle	Washington
United States	University of Kansas Medical Center Research Institute	Westwood	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Gemin X

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the rate of morphologic CR after treatment in the obatoclax single-agent therapy in older patients with previously untreated AML.		4 weeks	No