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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)


Phase 2
70 Years
N/A
Not Enrolling
Both
AML

Thank you

Trial Information

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)


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

4 weeks

Safety Issue:

No

Principal Investigator

Jean Viallet, MD

Investigator Role:

Study Director

Investigator Affiliation:

Gemin X Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

GEM016

NCT ID:

NCT00684918

Start Date:

April 2008

Completion Date:

December 2009

Related Keywords:

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

Name

Location

MD Anderson Cancer CenterHouston, Texas  77030-4096
St. Joseph Mercy HospitalPontiac, Michigan  48341-2985
St. Vincent's Comprehensive Cancer CenterNew York, New York  10011
Northwestern UniversityChicago, Illinois  60611
Dana Farber Cancer InstituteBoston, Massachusetts  02115
Michigan State University - Breslin Cancer CenterEast Lansing, Michigan  48824-1313
The University of IowaIowa City, Iowa  52242
University of Michigan Health SystemAnn Arbor, Michigan  
Benaroya Research Institute at Virginia MasonSeattle, Washington  98101
University of Kansas Medical Center Research InstituteWestwood, Kansas  66205
Legacy Emanuel Hospital & Health CenterPortland, Oregon  97210
Penn State Hershey Cancer Institute-Clinical Trials OfficeHershey, Pennsylvania  17033