A Randomized, Double-blind, Placebo Controlled, Multicenter Phase II Study to Assess the Efficacy and Safety of Sorafenib Added to Standard Treatment With Topotecan in Patients With Platinum-resistant Recurrent Ovarian Cancer

Trial ID # NCT01047891
Phase II
Drug Class Angiogenesis Inhibitors: Multi-targeted RTK
Drug Name Sorafenib
Alternate Drug Names BAY 43-9006, BAY 43-9006 tosylate salt, BAY 54-9085, Nexavar, SFN
Drugs in Trial Sorafenib, Topotecan
Eligible Participant

Platinum resistant or refractory ovarian cancer with ≤ 2 prior therapies

Patients Enrolled

185, median 2 prior therapies (1-3); 90% primary Pt-R, 10% primary Pt-Rf

Therapy Setting


Study Design

Double Blind, Randomized


ORR, DoR, PFS, OS, evaluated per RECIST


Sor+Top (n=83) vs Placebo+Top (n=89):

ORR: 31 vs 12% (p=0.036)
DoR: 21.0 vs 14.0 months (p=0.24)
PFS: 6.7 vs 4.4 months, HR: 0.60 (0.43-0.83, p=0.0018)
OS: 17.1 vs 10.1 months, HR: 0.65 (0.45-0.93, p=0.017)

Clinically Significant Adverse Events

Sor+Top vs Placebo+Top:
Serious AE: overall (59 vs 51%), abdominal pain (10 vs 6%)
Grade 3-4 AE: leukopenia (69 vs 53%), neutropenia (55 vs 54%), thrombocytopenia (28 vs 22%), hand-foot skin reaction (13 vs 0%)


Sorafenib given with topotecan (5-day schedule) and continued as maintenance therapy results in a significant improvement in ORR, PFS and OS


Chekerov R et al. Sorafenib plus topotecan versus placebo plus topotecan for platinum-resistant ovarian cancer (TRIAS): a multicentre, randomised, double-blind, placebo-controlled, phase 2 trial. Lancet Oncol (2018) 19(9):1247-1258

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