Clinical Trial Details
EORTC-1212-GCG
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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)
| 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 |
Corneel Coens (Statistician) , EORTC Headquarters, Brussels Sandrine Marreaud (Clinical Research Physician) , EORTC Headquarters, Brussels Sara Meloen (Pharmacovigilance Manager) , EORTC Headquarters, Brussels Ellen Peeters (Senior Clinical Operations Manager) , EORTC Headquarters, Brussels |
| Type of cancer |
Ovarian Endometrium |
| Participating groups |
EORTC Gynecological Cancer Group Scottish Gynaecological Cancer Trials Group |
| Recruiting centers | Radboud University Medical Center Nijmegen (Nijmegen, Netherlands) |
| Protocol summary | http://clinicaltrials.gov/study/NCT02866370 |
| NCT number | NCT02866370 |
| EudraCT | 2013-002109-73 |
| Financial Support |
Educational Grant EORTC Group |
