Journal article
A phase 1b study of trebananib in combination with pegylated liposomal doxorubicin or topotecan in women with recurrent platinum-resistant or partially platinum-sensitive ovarian cancer
I Vergote, RJ Schilder, CH Pippitt, S Wong, AN Gordon, S Scudder, F Kridelka, L Dirix, JW Leach, S Ananda, N Nanayakkara, R Melara, MB Bass, J Litten, H Adewoye, RM Wenham
Gynecologic Oncology | ACADEMIC PRESS INC ELSEVIER SCIENCE | Published : 2014
Abstract
Objective. To examine the tolerability and antitumor activity of trebananib plus pegylated liposomal doxorubicin (PLD) or topotecan in recurrent platinum-resistant or partially platinum-sensitive ovarian cancer.Methods. In this open-label phase 1b study, patients received trebananib 10 mg/kg or 15 mg/kg IV QWplus PLD 50 mg/m2 (cohorts A1 and A3, respectively) or topotecan 4 mg/m2 (cohorts B1 and B3, respectively). Endpoints were dose-limiting toxicity (DLT; primary); treatment-emergent adverse events (AEs), overall response rate, anti-trebananib antibodies, and pharmacokinetics (secondary).Results. 103 patients were enrolled. One patient in A1 and B1 had DLTs. Across all cohorts, themost com..
View full abstractGrants
Awarded by National Institutes of Health
Funding Acknowledgements
This study was funded by Amgen Inc. Employees of Amgen Inc. were involved in the study design, the collection, the analysis, and the interpretation of data, and the decision to submit the manuscript for publication.