European Trial on Enhanced DNA Repair Inhibition in Ovarian Cancer
Status:
Active, not recruiting
Trial end date:
2022-06-30
Target enrollment:
Participant gender:
Summary
This study will be performed in women with platinum-sensitive, high-grade serous, high-grade
endometrioid, undifferentiated epithelial ovarian cancer, carcinosarcoma, fallopian tube or
primary peritoneal cancer (proven by central histo-pathological review).
A total of 120 subjects will be randomized (1:1:1) to three different treatment arms: (A)
Standard arm (arm A): Carboplatin (AUC5 d1, q3w i.v.) in combination with Paclitaxel (175
mg/m² d1, q3w i.v.) or Carboplatin (AUC4 d1, q3w i.v.) in combination with Gemcitabine (1000
mg/m² d1, d8, q3w i.v.) followed by maintenance therapy with Niraparib (200/ 300 mg oral
daily, q4w) // (B) First experimental arm (arm B): Ganetespib (150 mg/m2, d1, q3w) in
combination with Carboplatin (AUC5 d1, q3w i.v.) followed by maintenance treatment with
Niraparib (200/ 300 mg oral daily, q4w) // (C) Second experimental arm (arm C): Ganetespib
(150 mg/m² d1, q3w i.v.) plus Carboplatin (AUC5 d1, q3w i.v.) followed by Ganetespib (100
mg/m² d1, d8, d15, d22, q4w i.v.) and Niraparib (200 mg oral daily, q4w).
Chemotherapy treatment will be given for 6 cycles, maintenance treatment with Ganetespib will
be given for a maximum of 9 months or until disease progression, maintenance treatment with
Niraparib can continue until disease progression.