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)
18 Years
N/A
Both
Myelofibrosis
Trial Information
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.
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Determine the steady-state pharmacokinetic parameters and pharmacodynamic response.
Outcome Time Frame:
1 Year
Safety Issue:
No
Principal Investigator
Jean Viallet, MD
Investigator Role:
Study Director
Investigator Affiliation:
Gemin X, Inc.
Authority:
United States: Food and Drug Administration
Study ID:
GEM007
NCT ID:
NCT00360035
Start Date:
July 2006
Completion Date:
February 2009
Related Keywords:
- Myelofibrosis
- Primary Myelofibrosis
- Metaplasia
Name | Location |
|---|---|
| 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 |
