Combination Chemotherapy With Nintedanib / Placebo in Endometrial Cancer

PHASE2CompletedINTERVENTIONAL
Enrollment

146

Participants

Timeline

Start Date

December 12, 2016

Primary Completion Date

October 20, 2021

Study Completion Date

November 25, 2021

Conditions
Endometrial Cancer
Interventions
DRUG

Nintedanib or Placebo; Carboplatin, Paclitaxel

Arm A: Nintedanib: 200mg orally twice daily d 2-21 q 21 days x 6 courses; afterwards daily dosing, until PD Arm B: Placebo: orally twice daily d 2-21 q 21 days x 6 courses; afterwards daily dosing, until PD In both arms: 6 courses of standard carboplatin and paclitaxel: Carboplatin AUC 5 iv every 21 days; Paclitaxel 175mg/m2 iv every 21 days. Both drugs are continued for maximum six courses or until unacceptable toxicity

Trial Locations (37)

1200

Cliniques universitaires Saint-Luc, Brussels

2100

Rigshospitalet, Copenhagen

2650

Antwerp University Hospital, Edegem

3000

University Hospitals Leuven, Leuven

5000

Odense Universitetshospital, Odense

7100

Vejle Sygehus, Vejle

9000

Ghent University Hospital, Ghent

Aalborg Universitetshospital, Aalborg

9300

Onze Lieve Vrouwziekenhuis, Aalst

13009

Institut Paoli Calmettes, Marseille

13353

Charité Campus Virchow Clinic, Berlin

14076

Centre François Baclesse, Caen

18059

Universitätsfrauenklinik am Klinikum Südstadt Rostock, Rostock

20246

Universitätsklinikum Hamburg-Eppendorf, Hamburg

33076

Institute Bergonié, Bordeaux

33520

Tampere University Hospital, Tampere

44800

Institut de Cancérologie de l'Ouest, Saint-Herblain

45122

Universitätsklinikum Essen, Essen

45135

Kliniken Essen Mitte, Essen

55131

Universitätsfrauenklinik Mainz, Mainz

58185

Linköping University Hospital, Linköping

59020

Centre Oscar Lambret, Lille

60596

Center of Gynecology and Obstetrics, Frankfurt

69008

Léon Bérard Center, Lyon

70029

Kuopio University Hospital, Kuopio

75012

Hospital Group Diaconesses Croix Saint-Simon, Paris

76137

St. Vincentius-Kliniken gAG Frauenklinik mit Hebammenlehranstalt, Karlsruhe

89075

Universitätsfrauenklinik Ulm, Ulm

Unknown

ICM (Cancer Institute of Montpellier), Montpellier

06189

Centre Antoine Lacassagne, Nice

22 190

Private Hospital Of Côtes D'armor, Plérin

09116

Klinik Chemnitz gGmbH, Chemnitz

01307

University Hospital Carl Gustav Carus Dresden, Dresden

0450

Oslo University Hospital, Oslo

221 85

Skåne University Hospital, Lund

171 76

Karolinska University Hospital, Stockholm

751 85

Uppsala University Hospital, Uppsala

All Listed Sponsors
collaborator

North Eastern German Society of Gynaecological Oncology

OTHER

collaborator

Belgian Gynaecological Oncology Group

OTHER

collaborator

ARCAGY/ GINECO GROUP

OTHER

lead

Nordic Society of Gynaecological Oncology - Clinical Trials Unit

OTHER

NCT02730416 - Combination Chemotherapy With Nintedanib / Placebo in Endometrial Cancer | Biotech Hunter | Biotech Hunter