Efficacy and Safety Study of Sorafenib With Topotecan in Patients With Platinum-resistant Recurrent Ovarian Cancer
Status:
Completed
Trial end date:
2015-02-01
Target enrollment:
Participant gender:
Summary
It is assumed, that the patients of the standard arm show a median progression-free survival
time of 4.4 months those of the experimental arm of at least 6.9 months. Assuming a
recruitment period of 18 months and follow-up for at least 12 months a total sample size of
174 patients is required (two-sided, α=0.05, 80% power). To account for 5% drop-outs 184
patients will be randomized.
A Data Monitoring and Safety Board (DMSB) will be established. This board will evaluate the
safety profile of the drug combination after 6 patients and after 12 patients have received 1
cycle of treatment.