| Phase II study of obatoclax mesylate (GX15-070), a small-molecule BCL-2 family antagonist, for patients with myelofibrosis. | |
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MedLine Citation:
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PMID: 20709666 Owner: NLM Status: In-Process |
Abstract/OtherAbstract:
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BACKGROUND: Myelofibrosis (MF) is a disease characterized by the overexpression of the antiapoptotic BCL-2 family of proteins (eg, BCL-XL and MCL-1). PATIENTS AND METHODS: We conducted a multicenter, open-label, noncomparative phase II study of obatoclax mesylate, a small-molecule pan-BCL-2 antagonist, in patients with MF. Obatoclax was administered as a 24-hour infusion (on an outpatient basis) every 2 weeks at a fixed dose of 60 mg. RESULTS: A total of 22 patients were enrolled, with a median age of 63 years (range, 43-89 years). Twelve were men, and all 22 patients were previously treated (median of 2 previous therapies). Ten patients (45%) had a Lille score of 1, and 9 patients (41%) had a Lille score of 2. Thirteen (59%) were red blood cell transfusion dependent. A median of 7 cycles of obatoclax were administered. No patient achieved complete or partial response according to International Working Group criteria. One patient (4%) demonstrated a clinical improvement (in terms of hemoglobin and platelet count) after 7 cycles of therapy. The improvement was sustained for 4 cycles of therapy, after which he underwent allogeneic stem cell transplantation. The most common adverse events included low-grade ataxia and fatigue in 50% of the patients. Dose reduction because of toxicity was required in 1 patient, whereas 2 patients were taken off the study because of grade 3 ataxia and grade 3 heart failure. Grade 3/4 anemia and thrombocytopenia were evident in 6 (27%) and 4 (18%) patients, respectively. CONCLUSION: Obatoclax exhibits no significant clinical activity in patients with MF at the dose and schedule evaluated. |
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Authors:
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Sameer A Parikh; Hagop Kantarjian; Aaron Schimmer; William Walsh; Ekatherine Asatiani; Khaled El-Shami; Elliott Winton; Srdan Verstovsek |
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Publication Detail:
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Type: Journal Article; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: Clinical lymphoma, myeloma & leukemia Volume: 10 ISSN: 2152-2669 ISO Abbreviation: Clin Lymphoma Myeloma Leuk Publication Date: 2010 Aug |
Date Detail:
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Created Date: 2010-08-16 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 101525386 Medline TA: Clin Lymphoma Myeloma Leuk Country: United States |
Other Details:
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Languages: eng Pagination: 285-9 Citation Subset: IM |
Affiliation:
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Department of Leukemia, University of Texas M. D. Anderson Cancer Center, Houston, TX 77030, USA. |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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