Alliance A091103 a phase II study of the angiopoietin 1 and 2 peptibody trebananib for the treatment of angiosarcoma Journal Article
| Authors: | D'Angelo, S. P.; Mahoney, M. R.; Van Tine, B. A.; Adkins, D. R.; Perdekamp, M. T. G.; Condy, M. M.; Luke, J. J.; Hartley, E. W.; Antonescu, C. R.; Tap, W. D.; Schwartz, G. K. |
| Article Title: | Alliance A091103 a phase II study of the angiopoietin 1 and 2 peptibody trebananib for the treatment of angiosarcoma |
| 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. © 2015 Springer-Verlag Berlin Heidelberg. |
| Keywords: | adult; treatment outcome; aged; aged, 80 and over; disease-free survival; middle aged; survival rate; young adult; clinical trial; angiogenesis inhibitor; disease free survival; phase 2 clinical trial; angiosarcoma; hemangiosarcoma; blood; hybrid protein; recombinant fusion proteins; multicenter study; angiogenesis inhibitors; angiopoietin 2; angiopoietin 1; angiopoietin-1; angiopoietin-2; very elderly; humans; human; male; female; trebananib; angiopoietin system |
| Journal Title: | Cancer Chemotherapy and Pharmacology |
| Volume: | 75 |
| Issue: | 3 |
| ISSN: | 0344-5704 |
| Publisher: | Springer |
| Date Published: | 2015-03-01 |
| Start Page: | 629 |
| End Page: | 638 |
| Language: | English |
| DOI: | 10.1007/s00280-015-2689-8 |
| PUBMED: | 25672915 |
| PROVIDER: | scopus |
| PMCID: | PMC4699670 |
| DOI/URL: | |
| Notes: | Export Date: 4 May 2015 -- Source: Scopus |
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