Safety and efficacy results from two randomized expansions of a phase I study of a tablet formulation of the PARP inhibitor, olaparib, in ovarian and breast cancer patients with BRCA1/2 mutations.

• DOI: 10.1200/jco.2012.30.15_suppl.3048
• Publication Date: 2020-03-11T15:10:19Z
• Authors: L Rhoda Molife; Joaquin Mateo; Trevor McGoldrick; Matthew Krebs; Yvette Drew; Susana N. Banerjee; Shibani Nicum; Malcolm Ranson; Gordon J. S. Rustin; Cristiana Sessa; Ruth Plummer; Karin Leunen; Michael Friedlander; Helen Swaisland; Wendy Burke; Peter McCormack; Kristine Pemberton; Ilian Tchakov; Stanley B. Kaye; Charlie Gourley
• Keywords: Olaparib; Tolerability; BRCA Mutation; PARP inhibitor

3048 Background: We previously reported the comparative bioavailability of capsule (CAP) formulation olaparib and more convenient new tablet (TAB) (Molife et al ASCO 2010). subsequently performed two separate dose expansions (DE1 DE2) to explore safety efficacy TAB (NCT00777582). Methods: Patients with breast or ovarian cancer BRCA1/2 mutations, ECOG PS 0–2 adequate organ function were randomized receive: DE1: 200 400 CAP; DE2: 300 TAB, CAP (all mg BID). Endpoints included safety, pharmacokinetics exploratory analysis (change in tumor size at 8 weeks by RECIST 1.0). Groups compared using covariance, including baseline treatment as covariates; results are presented least square (LS) means. Results: 24 patients (ovarian n=15, n=9) entered DE1 53 n=38, n=15) DE2. Baseline characteristics age, BRCA mutation status histology balanced. The table shows key toxicity-related information change cohort. Conclusions: These data suggest a dose-response effect for tolerability and, possibly, between BID. Further studies will require dosing according patient within this range. [Table: see text]