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

Myelofibrosis Clinical Trial

Official title:

A Multi-Center, Open-Label, Phase II Study of Single-Agent GX15-070MS Administered as a 24-Hour Infusion Every 2 Weeks to Patients With Myelofibrosis With Myeloid Metaplasia (MF)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00360035
• Other study ID #: GEM007
• Status: Completed
• Phase: Phase 2
• First received: August 1, 2006
• Last updated: August 16, 2013
• Start date: July 2006
• Est. completion date: February 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

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: February 2009
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metaplasia
• Myelofibrosis
• Primary Myelofibrosis

Intervention

Drug:
• Obatoclax mesylate (GX15-070MS)
60 mg q2wks

Locations

Country	Name	City	State
Canada	Princess Margaret Hospital	Toronto	Ontario
United States	Emory University	Atlanta	Georgia
United States	The University of Chicago	Chicago	Illinois
United States	MD Anderson Cancer Center	Houston	Texas
United States	James A. Haley Veterans Hospital	Tampa	Florida
United States	Georgetown University Medical Center	Washington	District of Columbia
United States	University of Massachusetts Medical Center	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Gemin X

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

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; — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the steady-state pharmacokinetic parameters and pharmacodynamic response.		1 Year	No
Secondary	Peripheral blood counts		4 Weeks to 1 Year	Yes
Secondary	Bone marrow aspirates and biopsies		8 weeks to 1 year	Yes
Secondary	Transfusion and growth factor requirements		8 weeks to 1 year	Yes