MedDataX Logo

Safety and Efficacy of Obatoclax Mesylate (GX15-070MS) in the Treatment of Myelofibrosis With Myeloid Metaplasia

NCT ID: NCT00360035

Last Updated: 2013-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2009-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Defects in the apoptotic process can lead to the onset of cancer by allowing cells to grow unchecked when an oncogenic signal is present. Obatoclax is designed to restore apoptosis through inhibition of the Bcl-2 family of proteins, thereby reinstating the natural process of cell death that is often inhibited in cancer cells.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a multi-center, open-label, Phase II study of single-agent obatoclax administered in 2-week cycles as a 24-hour infusion every 2 weeks at a fixed dose of 60 mg to patients with myelofibrosis. Infusions may be administered on an outpatient basis. No investigational or commercial agents or therapies other than those described in the protocol may be administered with the intent to treat the patient's malignancy. Supportive care measures including those directed at controlling symptoms resulting from myelofibrosis (blood products, growth factor, hydroxyurea, etc.) are allowed.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Myelofibrosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

GX15-070MS

Obatoclax mesylate 60mg

Group Type EXPERIMENTAL

Obatoclax mesylate (GX15-070MS)

Intervention Type DRUG

60 mg q2wks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Obatoclax mesylate (GX15-070MS)

60 mg q2wks

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Histologically confirmed myelofibrosis with myeloid metaplasia.
* No limitations on allowable type and amount of prior therapy.
* Patients must have normal organ function.
* Must be willing to submit to blood sampling for planned PK and PD analyzes.
* Must have ability to understand and willingness to sign a written informed consent form.

Exclusion Criteria

* No other agents or therapies administered with the intent to treat malignancy.
* Patients with prior exposure to obatoclax.
* Uncontrolled, intercurrent illness.
* Pregnant women and women who are breast feeding.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Gemin X

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jean Viallet, MD

Role: STUDY_DIRECTOR

Gemin X, Inc.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Georgetown University Medical Center

Washington D.C., District of Columbia, United States

Site Status

James A. Haley Veterans Hospital

Tampa, Florida, United States

Site Status

Emory University

Atlanta, Georgia, United States

Site Status

The University of Chicago

Chicago, Illinois, United States

Site Status

University of Massachusetts Medical Center

Worcester, Massachusetts, United States

Site Status

MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Princess Margaret Hospital

Toronto, Ontario, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Canada

References

Explore related publications, articles, or registry entries linked to this study.

Parikh SA, Kantarjian H, Schimmer A, Walsh W, Asatiani E, El-Shami K, Winton E, Verstovsek S. Phase II study of obatoclax mesylate (GX15-070), a small-molecule BCL-2 family antagonist, for patients with myelofibrosis. Clin Lymphoma Myeloma Leuk. 2010 Aug;10(4):285-9. doi: 10.3816/CLML.2010.n.059.

Reference Type RESULT
PMID: 20709666 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

GEM007

Identifier Type: -

Identifier Source: org_study_id