Statistical analysis
toxicity, PD, death
DISEASE PROGRESSION, EVENT
The phase I of this study was designed to ensure an adequate assessment of the toxicity of topotecan with pazopanib and to determine MTD and DLT, based on the continuous reassessment method. A maximum of 18 patients may be enrolled in three pre-planned dose escalation levels. After each dose level step of this part of the trial an interim safety analysis was performed.Based on the published results of the phase 3 TOWER study, the assumed median PFS of the conventional topotecan monotherapy was 4.4 months (Sehouli et al. Median PFS, as primary objective of the phase II, was defined as the time (months) from start of the first treatment cycle until disease progression (PD) or death, or date of last follow-up. Duration of response was defined as time from first assessment of response until PD or death, and the time to progression was the time from start of the first therapy cycle until PD is observed.All analyses of therapeutic efficacy will be summarised, in addition to a qualitative review of safety, tolerability and quality of life conducted in an exploratory fashion. Results are presented as raw numbers, rates, medians with 95% CI or ranges. Event related data like progression free survival, time to progression, duration of response and overall survival time was analysed by the non-parametric Kaplan–Meier method. All statistical calculations were implemented by SAS (Statistical Analysis System, SAS Institute, North Carolina, USA). This trial is registered with ClinicalTrials.gov, number NCT01600573.