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.
Ignace Vergote, Russell J Schilder, Charles H Pippitt, Shirley Wong, Alan N Gordon, Sidney Scudder, Frederic Kridelka, Luc Dirix, Joseph W Leach, Sumitra Ananda, Nuwan Nanayakkara, Rebeca Melara, Michael B Bass, Jason Litten, Henry Adewoye, Robert M Wenham
Gynecol Oncol | Published : 2014
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 QW plus PLD 50 mg/m(2) (cohorts A1 and A3, respectively) or topotecan 4 mg/m(2) (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, the ..View full abstract