Topotecan (T) Plus Pazopanib (P) In Platinum-Resistant Or Intermediate-Sensitive Ovarian Cancer: A Phase I/Ii Single-Arm Multicentre Trial Of The North-Eastern German Society Of Gynaecologic Oncology: Topaz.

e17553Background: Pazopanib(P), an oral multi TK-inhibitor was combined with topoisomerase inhibitor topotecan (T) given in a weekly schedule in patients with first or second recurrence of ovarian cancer. Methods: Eligible patients had resistant of intermediate-sensitive recurrence (progression ≤ 12 mo after ≥ 4 platinum cycles) and ≤ 2 prior chemotherapy lines. In a dose-escalation step a maximal tolerable dose (MTD) of 400mg pazopanib daily was selected for combination with topotecan. The phase-II-trial registered patients to weekly topotecan 4 mg/m² (day 1,8,15, 28 day cycle) and pazopanib 400 mg/daily, for 6 chemotherapy cycles and in case of CR, PR or SD maintenance with pazopanib untill progression. The number of treatment lines was stratified. The primary objective was dose-limiting toxicity (part I) and PFS (part II). Secondary endpoints include OAS, objective response, safety. Results: Inside the 60 eligible patients of the ITT cohort with median age 55 (30-76 years), 19 pts were in second and 41...