EPIK-O: A Phase III, multi-center, 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

Conditions

high-grade serous ovarian cancer with no germline BRCA mutation, Platinum-resistant or refractory

Brief summary

PFS based on BIRC assessment using RECIST 1.1 criteria

Detailed description

OS, Safety: Incidence, type and severity of adverse events per CTCAE v4.03 criteria including changes in laboratory values, vital signs, hepatic, renal and cardiac assessments. Tolerability: dose interruptions, reductions, dose intensity and duration of exposure for all drug components., Time to definitive deterioration of the ECOG performance status from baseline, Overall Response Rate (ORR) with confirmed response, Clinical Benefit Rate (CBR) with confirmed response, Duration Of Response (DOR) with confirmed response and Time To Response (TTR) (based on BIRC assessment using RECIST 1.1 criteria), Summary of statistics of PK parameters (including but not limited to AUCtau, AUClast, Cmax, Tmax) of alpelisib and olaparib (full PK subset only), Summary of statistics of plasma alpelisib and olaparib concentrations by time point., Change from baseline in Function Assessment of Cancer Therapy-Ovarian Trial Outcome Index (FACT-O)

Related papers

No related papers found yet.

Interventions

DRUGPACLITAXEL

DRUGALPELISIB

DRUGDOXORUBICIN HYDROCHLORIDE

DRUGOLAPARIB

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
PFS based on BIRC assessment using RECIST 1.1 criteria	—

Secondary

Measure	Time frame
OS, Safety: Incidence, type and severity of adverse events per CTCAE v4.03 criteria including changes in laboratory values, vital signs, hepatic, renal and cardiac assessments. Tolerability: dose interruptions, reductions, dose intensity and duration of exposure for all drug components., Time to definitive deterioration of the ECOG performance status from baseline, Overall Response Rate (ORR) with confirmed response, Clinical Benefit Rate (CBR) with confirmed response, Duration Of Response (DOR) with confirmed response and Time To Response (TTR) (based on BIRC assessment using RECIST 1.1 criteria), Summary of statistics of PK parameters (including but not limited to AUCtau, AUClast, Cmax, Tmax) of alpelisib and olaparib (full PK subset only), Summary of statistics of plasma alpelisib and olaparib concentrations by time point., Change from baseline in Function Assessment of Cancer Therapy-Ovarian Trial Outcome Index (FACT-O)	—

Measure

Time frame

OS, Safety: Incidence, type and severity of adverse events per CTCAE v4.03 criteria including changes in laboratory values, vital signs, hepatic, renal and cardiac assessments. Tolerability: dose interruptions, reductions, dose intensity and duration of exposure for all drug components., Time to definitive deterioration of the ECOG performance status from baseline, Overall Response Rate (ORR) with confirmed response, Clinical Benefit Rate (CBR) with confirmed response, Duration Of Response (DOR) with confirmed response and Time To Response (TTR) (based on BIRC assessment using RECIST 1.1 criteria), Summary of statistics of PK parameters (including but not limited to AUCtau, AUClast, Cmax, Tmax) of alpelisib and olaparib (full PK subset only), Summary of statistics of plasma alpelisib and olaparib concentrations by time point., Change from baseline in Function Assessment of Cancer Therapy-Ovarian Trial Outcome Index (FACT-O)

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Countries

Finland, Germany, Spain

Outcome results

None listed