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

Official Title

EPIK-O: A Phase III, Multi-centre, Randomized (1:1), Open-label, Active-controlled, Study to Assess the Efficacy and Safety of Alpelisib (BYL719) in Combination With Olaparib as Compared to Single Agent Cytotoxic Chemotherapy, in Participants With no Germline BRCA Mutation Detected, Platinum-resistant or Refractory, High-grade Serous Ovarian Cancer

Summary:

The objective of this study is 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.

Trial Description

Primary Outcome:

• Progression Free Survival (PFS) based on Blinded Independent Review Committee (BIRC) assessment using RECIST 1.1 criteria

• Overall survival
• Number of participants with dose interruptions and dose reductions
• Dose intensity
• Time to definitive deterioration of the Eastern Cooperative Oncology Group (ECOG) performance status (PS)
• Overall Response Rate (ORR) with confirmed response based on BIRC assessment according to RECIST 1.1 criteria
• Clinical benefit rate (CBR) with confirmed response based on BIRC assessment according to RECIST 1.1
• Time to response (TTR) based on BIRC assessment and according to RECIST 1.1
• Duration of response (DOR) with confirmed response based on BIRC assessment and according to RECIST 1.1
• Area under the curve calculated to the end of a dosing interval (tau) at steady-state (AUCtau) of alpelisib and olaparib
• Area under the curve from time zero to the last measurable concentration sampling time (AUClast)of alpelisib and olaparib
• Maximum Concentration (Cmax) of alpelisib and olaparib
• Time to reach maximum concentration (Tmax) of alpelisib and olaparib
• Change from baseline in Function Assessment of Cancer Therapy-Ovarian Trial Outcome Index (FACT-O TOI)

This study will include adult women with platinum resistant or refractory high-grade serous ovarian cancer, with no germline BRCA mutation detected. Participants will be randomized in a 1:1 ratio to either alpelisib plus olaparib or single agent cytotoxic chemotherapy (paclitaxel or PLD) in this open-label, active controlled study.

Participants will continue to receive study treatment until disease progression, unacceptable toxicity that precludes further treatment, or until discontinuation of study treatment due to any other reason. After treatment discontinuation, all participants will enter in the post-treatment follow-up period, which consists of a safety follow-up visit and a 9-week post-progression visit. Once they complete the post-treatment follow-up, participants will then enter the survival follow-up period.

View this trial on ClinicalTrials.gov