Alliance A091103 a phase II study of the angiopoietin 1 and 2 peptibody trebananib for the treatment of angiosarcoma

Sandra P. D'Angelo, Michelle R. Mahoney, Brian A. Van Tine, Douglas R. Adkins, Maria T.Grosse Perdekamp, Mercedes M. Condy, Jason J. Luke, Eliza Woodward Hartley, Cristina R. Antonescu, William D. Tap, Gary K. Schwartz

Research output: Contribution to journalArticlepeer-review

21 Scopus citations

Abstract

Introduction: Angiosarcomas are rare malignant endothelial cell tumors which have up-regulation of the angiopoietin system [e.g., Tie2 and Angiopoietin 2 (Ang2)]. Trebananib is a novel agent targeting Angiopoietin 1 and Angiopoietin 2. Methods: Trebananib 30 mg/kg was administered weekly until progressive disease or unacceptable toxicity. The primary endpoint was response rate by RECIST v1.1. Correlatives included: (1) baseline tumor expression of Ang2/Tie2 by immunohistochemistry, (2) serum levels of Ang1 and Ang2, (3) pre- and post-treatment phospho-receptor tyrosine kinase and (4) MYC/FLT-4 amplification status. Results: Sixteen patients were enrolled [median age 68 years (24-91), 38 % male, median number of prior therapies 2.5 (1-7)]. No responses were observed in 12 evaluable patients. Estimated median and 12-week progression-free survival rate were 7 weeks (95 % 6-8) and 25 % (95 % CI 11-58 %), respectively. Median overall survival was 28 weeks (95 % CI 17-48). There were two (12.5 %) patients who experienced grade 3 adverse event and one (6.3 %) patient who experienced grade 4 adverse event that was considered at least possibly related to treatment. Conclusions: Trebananib was well tolerated. Lack of response in the first stage of a Simon 2 stage design led to closure of this study. Prolonged PFS was observed in four pts, lasting 3.4-5.5 months.

Original languageEnglish
Pages (from-to)629-638
Number of pages10
JournalCancer Chemotherapy and Pharmacology
Volume75
Issue number3
DOIs
StatePublished - Mar 2015

Keywords

  • Angiopoietin system
  • Angiosarcoma
  • Trebananib

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