A Phase III, Randomised, Double Blind, Placebo Controlled, Multicentre Study of Olaparib Maintenance Monotherapy in Patients With BRCA Mutated Advanced (FIGO Stage III-IV) Ovarian Cancer Following First Line Platinum Based Chemotherapy.

Conditions

BRCA Mutated Advanced (FIGO Stage III-IV) Ovarian Cancer

Brief summary

Progression Free Survival (PFS) by investigator review of RECIST data

Detailed description

Efficacy in patients following First Line Platinum Based Chemotherapy by assessment of: a) overall survival b) time to earliest progression by RECIST or Cancer Antigen-125 (CA- 125) c) time from randomisation to second progression., The Trial Outcome Index (TOI) of the Functional Assessment of Cancer Therapy - Ovarian Cancer (FACT-O) will be used to determine: a) Change from baseline in TOI score b) Proportion improved, Development and delivery of a BRCA mutation companion diagnostic, Adverse events, physical examination, vital signs including blood pressure, pulse, electrocardiogram and laboratory findings including clinical chemistry and haematology, Efficacy of olaparib by time to first subsequent therapy or death (TFST)., Efficacy of olaparib by time to second subsequent therapy or death (TSST)., Efficacy of olaparib by time from randomisation to study treatment discontinuation or death (TDT).

Related papers

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Interventions

DRUGPlacebo - film-coated tablets

DRUGLynparza 100 mg film-coated tablets

DRUGLynparza 150 mg film-coated tablets

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Progression Free Survival (PFS) by investigator review of RECIST data	—

Secondary

Measure	Time frame
Efficacy in patients following First Line Platinum Based Chemotherapy by assessment of: a) overall survival b) time to earliest progression by RECIST or Cancer Antigen-125 (CA- 125) c) time from randomisation to second progression., The Trial Outcome Index (TOI) of the Functional Assessment of Cancer Therapy - Ovarian Cancer (FACT-O) will be used to determine: a) Change from baseline in TOI score b) Proportion improved, Development and delivery of a BRCA mutation companion diagnostic, Adverse events, physical examination, vital signs including blood pressure, pulse, electrocardiogram and laboratory findings including clinical chemistry and haematology, Efficacy of olaparib by time to first subsequent therapy or death (TFST)., Efficacy of olaparib by time to second subsequent therapy or death (TSST)., Efficacy of olaparib by time from randomisation to study treatment discontinuation or death (TDT).	—

Measure

Time frame

Efficacy in patients following First Line Platinum Based Chemotherapy by assessment of: a) overall survival b) time to earliest progression by RECIST or Cancer Antigen-125 (CA- 125) c) time from randomisation to second progression., The Trial Outcome Index (TOI) of the Functional Assessment of Cancer Therapy - Ovarian Cancer (FACT-O) will be used to determine: a) Change from baseline in TOI score b) Proportion improved, Development and delivery of a BRCA mutation companion diagnostic, Adverse events, physical examination, vital signs including blood pressure, pulse, electrocardiogram and laboratory findings including clinical chemistry and haematology, Efficacy of olaparib by time to first subsequent therapy or death (TFST)., Efficacy of olaparib by time to second subsequent therapy or death (TSST)., Efficacy of olaparib by time from randomisation to study treatment discontinuation or death (TDT).

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Countries

France, Italy, Netherlands, Poland, Spain

Outcome results

None listed