Clinical trial NCT00684918: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: AML
Keywords: AML, obatoclax
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2008-05-28
Enrollment: 18
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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:

  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

Primary outcomes:
measure: Determine the rate of morphologic CR after treatment in the obatoclax single-agent therapy in older patients with previously untreated AML.
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Iowa City
country: United States
facility: The University of Iowa
state: Iowa
city: Westwood
country: United States
facility: University of Kansas Medical Center Research Institute
state: Kansas
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Ann Arbor
country: United States
facility: St. Joseph Mercy Hospital
state: Michigan
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
city: Lansing
country: United States
facility: Michigan State University - Breslin Cancer Center
state: Michigan
city: New York
country: United States
facility: St. Vincent's Comprehensive Cancer Center
state: New York
city: Portland
country: United States
facility: Legacy Emanuel Hospital & Health Center
state: Oregon
city: Hershey
country: United States
facility: Penn State Hershey Cancer Institute-Clinical Trials Office
state: Pennsylvania
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Seattle
country: United States
facility: Benaroya Research Institute at Virginia Mason
state: Washington
city: Toronto
country: Canada
facility: Princess Margaret Hospital
state: Ontario
Study officials:
affiliation: Gemin X Pharmaceuticals
name: Jean Viallet, MD
role: STUDY_DIRECTOR
References:
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.