Safety and Efficacy of Obatoclax Mesylate (GX15-070MS) in the Treatment of Myelofibrosis With Myeloid Metaplasia
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: GX15-070MS Obatoclax mesylate 60mg |
Drug: Obatoclax mesylate (GX15-070MS)
60 mg q2wks
|
Outcome Measures
Primary Outcome Measures
- Determine the steady-state pharmacokinetic parameters and pharmacodynamic response. [1 Year]
Secondary Outcome Measures
- Peripheral blood counts [4 Weeks to 1 Year]
- Bone marrow aspirates and biopsies [8 weeks to 1 year]
- Transfusion and growth factor requirements [8 weeks to 1 year]
Eligibility Criteria
Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Georgetown University Medical Center | Washington | District of Columbia | United States | 20007 |
| 2 | James A. Haley Veterans Hospital | Tampa | Florida | United States | 33612 |
| 3 | Emory University | Atlanta | Georgia | United States | 30322 |
| 4 | The University of Chicago | Chicago | Illinois | United States | 60637 |
| 5 | University of Massachusetts Medical Center | Worcester | Massachusetts | United States | 01655 |
| 6 | MD Anderson Cancer Center | Houston | Texas | United States | 77030 |
| 7 | Princess Margaret Hospital | Toronto | Ontario | Canada | M5G 2M9 |
Sponsors and Collaborators
- Gemin X
Investigators
- Study Director: Jean Viallet, MD, Gemin X, Inc.
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GEM007