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01-09-2019 | Glioblastoma | Clinical Study

Phase II study of Dovitinib in recurrent glioblastoma

Authors: Mayur Sharma, Cathy Schilero, David M. Peereboom, Brian P. Hobbs, Paul Elson, Glen H. J. Stevens, Keith McCrae, Andrew B. Nixon, Manmeet S. Ahluwalia

Published in: Journal of Neuro-Oncology | Issue 2/2019

Abstract

Introduction

Dovitinib is an oral, potent inhibitor of FGFR and VEGFR, and can be a promising strategy in patients with recurrent or progressive glioblastoma (GBM).

Methods

This was an open label phase II study of two arms: Arm 1 included anti-angiogenic naïve patients with recurrent GBM and Arm 2 included patients with recurrent GBM that had progressed on prior anti-angiogenic therapy. Nineteen subjects were enrolled in Arm 1 and 14 subjects in Arm 2. The primary endpoint was 6-month progression-free survival (PFS-6) in Arm 1 and time to progression (TTP) in Arm 2. The secondary endpoints were toxicity, objective response rate (ORR) and overall survival.

Results

Patients in Arm 2 (compared to Arm 1) tended to have longer intervals from diagnosis to study entry (median 26.9 vs. 8.9 months, p = 0.002), experienced more recurrences (64%, had 3–4 prior recurrences compared to 0, p < 0.0001) and tended to be heavily pretreated (71% vs. 26–32% p = 0.04 or 0.02). 6-month PFS was 12% ± 6% for the Arm 1 and 0% for Arm 2. TTP was similar in both treatment arms (median 1.8 months Arm 1 and 0.7–1.8 months Arm 2, p = 0.36). Five patients (15%) had grade 4 toxicities and 22 patients (67%) had grade 3 toxicities. There were no significant differences between the two arms with respect to the amount of change in the levels of biomarkers from baseline.

Conclusion

Dovitinib was not efficacious in prolonging the PFS in patients with recurrent GBM irrespective of prior treatment with anti-angiogenic therapy (including bevacizumab).

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Title: Phase II study of Dovitinib in recurrent glioblastoma
Authors: Mayur Sharma
Cathy Schilero
David M. Peereboom
Brian P. Hobbs
Paul Elson
Glen H. J. Stevens
Keith McCrae
Andrew B. Nixon
Manmeet S. Ahluwalia
Publication date: 01-09-2019
Publisher: Springer US
Keywords: Glioblastoma
Glioblastoma
Glioblastoma
Bevacizumab
Published in: Journal of Neuro-Oncology / Issue 2/2019
Print ISSN: 0167-594X
Electronic ISSN: 1573-7373
DOI: https://doi.org/10.1007/s11060-019-03236-6

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Phase II study of Dovitinib in recurrent glioblastoma

Abstract

Introduction

Methods

Results

Conclusion

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Introduction

Methods

Results

Conclusion

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