21 / 24
•
Phase III randomized, placebo-controlled, double-blind, multicenter
•
Olaparib tablets administered at 600 mg daily for up to 2 years.
PAOLA 1 / ENGOT OV-25
Stratification factors:
First-line treatment outcome (complete resection after initial surgery and NED at
screening, complete resection at interval debulking surgery and NED at screening,
incomplete resection at initial or interval debulking surgery and in CR at screening, PR
at screening) & gBRCA status (yes, no, unknown)