Alpelisib Plus Olaparib in Platinum-resistant/Refractory, High-grade Serous Ovarian Cancer, With no Germline BRCA Mutation Detected

Phase 3 Terminated 358 enrolled Novartis Pharmaceuticals

RandomizedParallel-groupOpen-labelTreatment

Summary

The objective of this study was to assess the efficacy and safety of the combination of alpelisib and olaparib compared with single agent cytotoxic chemotherapy in patients with platinum resistant or refractory high-grade serous ovarian cancer, with no germline BRCA mutation detected.

Timeline

Start: 2021-07-22
Primary completion: 2023-04-21
Completion: 2026-01-19

Publications

Konstantinopoulos PA, Gonzalez-Martin A, Cruz FM, Friedlander M, Glasspool R, Lorusso D, Marth C, Monk BJ, Kim JW, Hinson P, Ajipa O, Pretre V, Han Y, Matulonis UA. EPIK-O/ENGOT-OV61: alpelisib plus olaparib vs cytotoxic chemotherapy in high-grade serous ovarian cancer (phase III study). Future Oncol. 2022 Oct;18(31):3481-3492. doi: 10.2217/fon-2022-0666. Epub 2022 Sep 6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Alpelisib	Small molecule	200 mg	Oral
Comparator	Doxorubicin	Other / unclassified	40 mg/m2	Intravenous
Comparator	Doxorubicin	Other / unclassified	50 mg/m2	Intravenous
Subject	Olaparib	Small molecule	200 mg	Oral
Comparator	Paclitaxel	Small molecule	80 mg/m2	Intravenous

Alpelisib Plus Olaparib in Platinum-resistant/Refractory, High-grade Serous Ovarian Cancer, With no Germline BRCA Mutation Detected

Summary

Timeline

Publications

Drugs

Indications