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Defects in the apoptotic process can lead to the onset of cancer by allowing cells to grow unchecked when an oncogeneic 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 obatoclax administered in 2-week cycles to patients with previously-untreated Myelodysplastic Syndromes with anemia and/or thrombocytopenia. Treatment may be administered on an outpatient basis. No investigational or commercial agents or therapies other than those described herein may be administered with the intent to treat the patient's malignancy. Supportive care measures including those directed at controlling symptoms resulting from Myelodysplastic Syndromes are allowed
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Obatoclax Mesylate | Experimental | Obatoclax Mesylate 30mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Obatoclax mesylate (GX15-070MS) | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| International Working Group (IWG) Response Criteria for MDS | Determine the response rate according to bone marrow blast count less than or equal to 10% | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Peripheral blood counts; Bone marrow aspirates and biopsies; Transfusions and growth factor requirements | hemoglobin level less than 10 g/dL and or platelets less than 50 x 10 9/L. Eastern Cooperative Onocology Group (ECOG) performance status: 0 fully active-2 ambulatory 50% of the time; and total bilirubin less than or equal to 2 mg/dL; normal limits of SGOT/SGPT and creatinine according to laboratory standards |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Berger, MD | Gemin X, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 00000 | United States | ||
| Georgetown University Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25052051 | Derived | Arellano ML, Borthakur G, Berger M, Luer J, Raza A. A phase II, multicenter, open-label study of obatoclax mesylate in patients with previously untreated myelodysplastic syndromes with anemia or thrombocytopenia. Clin Lymphoma Myeloma Leuk. 2014 Dec;14(6):534-9. doi: 10.1016/j.clml.2014.04.007. Epub 2014 Jun 12. |
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| 52 weeks |
| Washington D.C. |
| District of Columbia |
| 20007 |
| United States |
| James A. Haley Veterans Hospital | Tampa | Florida | 33612 | United States |
| Emory University School of Medicine/ Winship Cancer Center | Atlanta | Georgia | 30322 | United States |
| Northwest Georgia Oncology Centers | Marietta | Georgia | 30060 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| University of Massachusetts Medical Center | Worcester | Massachusetts | 01605 | United States |
| Michigan State University, Breslin Cancer Center CTO | Lansing | Michigan | 48910 | United States |
| Hematology-Oncology Centers of the Northern Rockies | Billings | Montana | 59101 | United States |
| St. Vincent's Comprehensive Cancer Center | New York | New York | 01605 | United States |
| Pacific Oncology | Portland | Oregon | 97210 | United States |
| The West Clinic | Memphis | Tennessee | 38120 | United States |
| Sarah Cannon Cancer Research Institute | Nashville | Tennessee | 37203 | United States |
| Arlington Cancer Center | Arlington | Texas | 76012 | United States |
| Texax Oncology, P.A., Presbyterian/ Mary Crowley Clinical Research Centers | Dallas | Texas | 75231 | United States |
| Mary Crowley Medical Research Center | Dallas | Texas | 75246 | United States |
| MD Anderson Cancer Center (Protocol 2006-0688) | Houston | Texas | 77030 | United States |
| Tom Baker Cancer Centre | Calgary | Alberta | Canada |
| QEII HSC | Halifax | Nova Scotia | B3H 2Y9 | Canada |
| Princess Margaret Hospital | Toronto | Ontario | M5G 2M9 | Canada |
| Hospital Notre-Dame du Chum | Montreal | Quebec | H2L4M1 | Canada |
| Maisonneuve-Rosemont Hospital | Montreal | Quebec | Canada |
| ID | Term |
|---|---|
| D009190 | Myelodysplastic Syndromes |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| ID | Term |
|---|---|
| C520962 | obatoclax |
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