Document Detail

Phase II study of obatoclax mesylate (GX15-070), a small-molecule BCL-2 family antagonist, for patients with myelofibrosis.
MedLine Citation:
PMID:  20709666     Owner:  NLM     Status:  MEDLINE    
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.
Sameer A Parikh; Hagop Kantarjian; Aaron Schimmer; William Walsh; Ekatherine Asatiani; Khaled El-Shami; Elliott Winton; Srdan Verstovsek
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Publication Detail:
Type:  Clinical Trial, Phase II; Journal Article; Multicenter Study; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Clinical lymphoma, myeloma & leukemia     Volume:  10     ISSN:  2152-2669     ISO Abbreviation:  Clin Lymphoma Myeloma Leuk     Publication Date:  2010 Aug 
Date Detail:
Created Date:  2010-08-16     Completed Date:  2011-02-15     Revised Date:  2014-06-13    
Medline Journal Info:
Nlm Unique ID:  101525386     Medline TA:  Clin Lymphoma Myeloma Leuk     Country:  United States    
Other Details:
Languages:  eng     Pagination:  285-9     Citation Subset:  IM    
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MeSH Terms
Aged, 80 and over
Antineoplastic Agents / administration & dosage*,  adverse effects
Middle Aged
Primary Myelofibrosis / drug therapy*,  metabolism
Proto-Oncogene Proteins c-bcl-2 / antagonists & inhibitors*,  metabolism
Pyrroles / administration & dosage*,  adverse effects
Grant Support
Reg. No./Substance:
0/Antineoplastic Agents; 0/Proto-Oncogene Proteins c-bcl-2; 0/Pyrroles; 0/obatoclax

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