SOLO-2
: Olaparib as maintenance treatment in
Platinum Sensitive Relapse in BRCA mut patients
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
ClinicalTrials.gov. NCT01844986. Accessed May 31, 2016.
•
Platinum-sensitive ovarian,
primary peritoneal, or
fallopian tube cancer in CR or
PR after ≥2 lines of platinum
therapy
•
Serous or endometrioid
high-grade histology
•
Documented deleterious
BRCA
mutation
Olaparib 300
mg PO bid to
progression
Placebo bid to
progression
R
2:1
n=176
n=88
DATA will be released in SGO 2017
