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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GX15-070MS | Experimental | Obatoclax mesylate 60mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Obatoclax mesylate (GX15-070MS) | Drug | 60 mg q2wks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Determine the steady-state pharmacokinetic parameters and pharmacodynamic response. | 1 Year |
| Measure | Description | Time Frame |
|---|---|---|
| Peripheral blood counts | 4 Weeks to 1 Year | |
| Bone marrow aspirates and biopsies | 8 weeks to 1 year | |
| Transfusion and growth factor requirements |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean Viallet, MD | Gemin X, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Georgetown University Medical Center | Washington D.C. | District of Columbia | 20007 | United States | ||
| James A. Haley Veterans Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20709666 | Result | 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. |
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| 8 weeks to 1 year |
| Tampa |
| Florida |
| 33612 |
| United States |
| Emory University | Atlanta | Georgia | 30322 | United States |
| The University of Chicago | Chicago | Illinois | 60637 | United States |
| University of Massachusetts Medical Center | Worcester | Massachusetts | 01655 | United States |
| MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| Princess Margaret Hospital | Toronto | Ontario | M5G 2M9 | Canada |
| ID | Term |
|---|---|
| D055728 | Primary Myelofibrosis |
| ID | Term |
|---|---|
| D009196 | Myeloproliferative Disorders |
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C520962 | obatoclax |
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