188
Participants
Start Date
June 30, 2012
Primary Completion Date
May 31, 2015
Study Completion Date
March 31, 2016
vargatef
"400 mg (200 mg twice daily) Route of administration= oral Twice daily (to be swallowed unchewed with a glass of water of about 250 mL. If taken twice the dose interval should be of around 12 hours at the same times every day, usually in the morning and the evening after food intake).~Continuous daily dosing until progression of disease or until criteria for interruption of treatment are met, no intake of Vargatef® (Nintedanib) on days of paclitaxel and carboplatin administration. The maximum time on monotherapy is 2 years."
placebo
"Contains 0 mg of Vargatef® (Nintedanib) in capsules matching 100 mg and 150 mg of Vargatef® (Nintedanib) Route of administration: oral Twice daily (to be swallowed unchewed with a glass of water of about 250 mL. If taken twice the dose interval should be of around 12 hours at the same times every day, usually in the morning and the evening after food intake).~Continuous daily dosing until progression of disease or until criteria for interruption of treatment is met, no intake of placebo on days of paclitaxel and carboplatin administration.~The maximum time on monotherapy is 2 years."
Centre Paul Papin, Angers
Institut Ste Catherine, Avignon
Clinique Tivoli, Bordeaux
Institut Bergonié, Bordeaux
Polyclinique Bordeaux Nord, Bordeaux
Centre François Baclesse, Caen
Centre Jean Perrin, Clermont-Ferrand
Centre Hospitalier Alpes Leman, Contamine-sur-Arve
Centre Hospitalier Intercommunal de Créteil, Créteil
Centre Hospitalier de Dax, Dax
Centre Georges François Leclerc, Dijon
Centre Hospitalier Régional Universitaire de Lille - Hôpital Huriez, Lille
Centre Oscar Lambret, Lille
Centre Hospitalier Universitaire Dupuytren, Limoges
Centre Léon bérard, Lyon
ICM Val d'Aurelle, Montpellier
Centre Catherine de Sienne, Nantes
Hôpital Privé du Confluent S.A.S., Nantes
Centre Antoine Lacassagne, Nice
Centre Hospitalier Régional, Orléans
Hôpital Cochin, Paris
Hôpital Européen Georges Pompidou, Paris
Hôpital Tenon, Paris
Institut Mutualiste Montsouris-Jourdan, Paris
Centre Hospitalier Lyon-sud, Pierre-Bénite
Milétrie - Centre Hospitalier Universitaire de Poitiers, Poitiers
Institut Jean Godinot, Reims
Centre Henri Becquerel, Rouen
Clinique Armoricaine de Radiologie, Saint-Brieuc
Hôpital René Huguenin, Saint-Cloud
ICO René Gauducheau, Saint-Herblain
Hôpital Civil, Strasbourg
Hôpitaux Du Leman, Thonon-les-Bains
Centre Claudius Régaud, Toulouse
Institut de Cancérologie de Lorraine, Vandœuvre-lès-Nancy
Gustave Roussy, Villejuif
ARCAGY/ GINECO GROUP
OTHER