A Study to Examine Olaparib Maintenance Retreatment in Patients With Epithelial Ovarian Cancer.

Phase 3 Completed 220 enrolled AstraZeneca European Network of Gynaecological Oncological Trial Groups (ENGOT) · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

The OReO study will be a Phase IIIb, randomised, double-blind, placebo-controlled, multicentre study to assess the efficacy and tolerability of Olaparib retreatment, versus matching placebo, in non-mucinous epithelial ovarian cancer (EOC) patients (including patients with primary peritoneal and/or fallopian tube cancer)

Timeline

Start: 2017-06-08
Primary completion: 2021-02-15
Completion: 2022-02-17

Outcome

Met primary endpoint

registry analysis (other test); Olaparib (BRCA1/2 +ve) vs Placebo (BRCA1/2 +ve); p = 0.0220; Hazard Ratio (HR) 0.566 (95% CI 0.372 to 0.868); Stratified log-rank NCT03106987 ↗

paper maintenance olaparib rechallenge provided a statistically significant, albeit modest, PFS improvement over placebo in both the BRCA-mutated and non-BRCA-mutated cohorts PMID 37797734 ↗

Publications

Pujade-Lauraine E, Selle F, Scambia G, Asselain B, Marme F, Lindemann K, Colombo N, Madry R, Glasspool R, Vergote I, Korach J, Lheureux S, Dubot C, Oaknin A, Zamagni C, Heitz F, Gladieff L, Rubio-Perez MJ, Scollo P, Blakeley C, Shaw B, Ray-Coquard I, Redondo A; OReO/ENGOT-ov38 investigators. Maintenance olaparib rechallenge in patients with platinum-sensitive relapsed ovarian cancer previously treated with a PARP inhibitor (OReO/ENGOT-ov38): a phase IIIb trial. Ann Oncol. 2023 Dec;34(12):1152-1164. doi: 10.1016/j.annonc.2023.09.3110. Epub 2023 Oct 4.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Olaparib	Small molecule	300 mg	Oral