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A Randomised Phase II Study of Nintedanib (BIBF 1120) compared to Chemotherapy in Patients with Recurrent Clear Cell Carcinoma of the Ovary or Endometrium (NiCCC)

Study documentation

Trial Status Closed to Patient Entry
Dates Date of activation: 11-Aug-2017
Date Step1 close: 26-Jul-2019
Data management at EORTC No
Design Phase 2
Randomized open label
Targeted Sample size EORTC Groups: 40 - All Groups: 120
Treatment Drug
Carboplatin, Doxorubicin, Paclitaxel, Topotecan, Nintedanib, Pegylated Liposomal Doxorubicin
Study Staff Anne Marie Westermann (Study Coordinator) , Amsterdam UMC - Locatie AMC, Amsterdam
Christine Bourguignon (Clinical Operations Assistant) , EORTC Headquarters, Brussels
Kin Jip Cheung (Senior Clinical Operations Manager) , EORTC Headquarters, Brussels
Corneel Coens (Statistician) , EORTC Headquarters, Brussels
Angelique Deleersnijder (Regulatory Affairs Manager) , EORTC Headquarters, Brussels
Sandrine Marreaud (Clinical Research Physician) , EORTC Headquarters, Brussels
Sara Meloen (Pharmacovigilance Manager) , EORTC Headquarters, Brussels
Type of cancer Ovarian
Participating groups EORTC Gynecological Cancer Group
Scottish Gynaecological Cancer Trials Group
Recruiting centers Amsterdam UMC - Locatie AMC (Amsterdam, Netherlands)
Radboud University Medical Center Nijmegen (Nijmegen, Netherlands)
Protocol summary
NCT number NCT02866370
EudraCT 2013-002109-73
Financial Support Educational Grant