Journal article
A randomized, double-blind, placebo-controlled phase 1b/2 study of ralimetinib, a p38 MAPK inhibitor, plus gemcitabine and carboplatin versus gemcitabine and carboplatin for women with recurrent platinum-sensitive ovarian cancer
I Vergote, F Heitz, P Buderath, M Powell, J Sehouli, CM Lee, A Hamilton, J Fiorica, KN Moore, M Teneriello, L Golden, W Zhang, C Pitou, R Bell, R Campbell, DL Farrington, K Bell-McGuinn, RM Wenham
Gynecologic Oncology | ACADEMIC PRESS INC ELSEVIER SCIENCE | Published : 2020
Abstract
Objective: This phase 1b/2 clinical trial (NCT01663857) evaluated the efficacy of ralimetinib in combination with gemcitabine (G) and carboplatin (C), followed by maintenance ralimetinib, for patients with recurrent platinum-sensitive epithelial ovarian cancer. Methods: Phase 1b was to determine the recommended phase 2 dose (RP2D) of ralimetinib administered Q12H on Days 1–10 (q21d) in combination with G (1000 mg/m2, Days 3 and 10) and C (AUC 4, Day 3) for six cycles. In phase 2, patients were randomized double-blind 1:1 to ralimetinib (R)+GC or placebo (P)+GC, for six cycles, followed by ralimetinib 300 mg Q12H or placebo on Days 1–14, q28d. Results: 118 patients received at least one dose ..
View full abstractGrants
Funding Acknowledgements
This study was sponsored by Eli Lilly and Company. Medical writing assistance was provided by Samantha Forster of ProScribe, part of the Envision Pharma Group, and was funded by Eli Lilly and Company. Envision Pharma's services complied with international guidelines for Good Publication Practice (GPP3).