Advanced/Recurrent Ovarian cancer
Conditions
Brief summary
Safety endpoints will include, but are not limited to, the following: - TEAEs, SAEs, AEs leading to dose modifications, procedure-related AEs. -Changes from baseline in vital signs, clinical laboratory assessments, ECGs, ECOG PS, and physical examinations.
Detailed description
The primary measure of interest is the estimate of ORR prior to IDS. Confirmation of response is not required., The measure of interest is the estimate of confirmed CA125 response rate prior to IDS., Plasma concentrations of saruparib and its metabolite(s) if applicable. Report plasma PK parameters, including but not limited to AUC, Cmax and tmax as data allow, of saruparib after single dose and/or multiple doses administration.
Interventions
DRUGSaruparib
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety endpoints will include, but are not limited to, the following: - TEAEs, SAEs, AEs leading to dose modifications, procedure-related AEs. -Changes from baseline in vital signs, clinical laboratory assessments, ECGs, ECOG PS, and physical examinations. | — |
Secondary
| Measure | Time frame |
|---|---|
| The primary measure of interest is the estimate of ORR prior to IDS. Confirmation of response is not required., The measure of interest is the estimate of confirmed CA125 response rate prior to IDS., Plasma concentrations of saruparib and its metabolite(s) if applicable. Report plasma PK parameters, including but not limited to AUC, Cmax and tmax as data allow, of saruparib after single dose and/or multiple doses administration. | — |
Countries
Italy, Spain
Outcome results
None listed