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)
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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Determine the steady-state pharmacokinetic parameters and pharmacodynamic response.
Jean Viallet, MD
Gemin X, Inc.
United States: Food and Drug Administration
|MD Anderson Cancer Center||Houston, Texas 77030-4096|
|Emory University||Atlanta, Georgia 30322|
|Georgetown University Medical Center||Washington, District of Columbia 20007|
|The University of Chicago||Chicago, Illinois 60637|
|James A. Haley Veterans Hospital||Tampa, Florida 33612|
|University of Massachusetts Medical Center||Worcester, Massachusetts 01605|