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

NCT ID: NCT00684918

Last Updated: 2013-08-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-04-30
• Study Completion Date: 2009-12-31

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.

Conditions

AML

Keywords

AML, obatoclax

Study Design

• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental

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

Group Type: EXPERIMENTAL

Obatoclax

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

GX15-070MS

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

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gemin X

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean Viallet, MD

Role: STUDY_DIRECTOR

Gemin X Pharmaceuticals

Locations

Northwestern University

Chicago, Illinois, United States

The University of Iowa

Iowa City, Iowa, United States

University of Kansas Medical Center Research Institute

Westwood, Kansas, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

St. Joseph Mercy Hospital

Ann Arbor, Michigan, United States

University of Michigan Health System

Ann Arbor, Michigan, 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

Penn State Hershey Cancer Institute-Clinical Trials Office

Hershey, Pennsylvania, United States

MD Anderson Cancer Center

Houston, Texas, United States

Benaroya Research Institute at Virginia Mason

Seattle, Washington, United States

Princess Margaret Hospital

Toronto, Ontario, Canada

Countries

United States; Canada

References

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.

Reference Type: DERIVED

PMID: 25285531 (View on PubMed)

Other Identifiers

GEM016

Identifier Type: -

Identifier Source: org_study_id