First line: Olaparib SOLO-1 Phase III trial (BRCA
mut
)
•
Primary endpoint
: PFS
•
Secondary endpoints
: OS, time to earliest progression by RECIST or CA-125 or death, PFS2,
best ORR, health-related quality of life by TOI of the FACT-O, TDT, TFST, TSST, and safety and
tolerability
•
Newly diagnosed stage III-IV ovarian, primary
peritoneal, or fallopian tube cancer
•
Serous or endometrioid high-grade histology
•
Stage III: 1 optimal debulking attempt
•
Stage IV: biopsy and/or 1 upfront or interval
debulking
•
In CR or PR at end of frontline
platinum-based chemotherapy
•
Documented deleterious
BRCA
mutation
Olaparib 300
mg PO bid to
progression
Placebo bid to
progression
R
2:1
n=230
n=115
ClinicalTrials.gov Identifier:
NCT01844986
