Spots Global Cancer Trial Database for GINECO-EN102b - BKM120 as Monotherapy in the Treatment of Initial or Recurrent Metastatic Endometrial Cancer
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Trial Identification
Brief Title: GINECO-EN102b - BKM120 as Monotherapy in the Treatment of Initial or Recurrent Metastatic Endometrial Cancer
Official Title: Phase 2 Multicenter Study to Assess the Safety and Efficacy of BKM120 as Monotherapy in Treatment of Initial or Recurrent Metastatic Endometrial Cancer After 1st Line Therapy in Patients Who Cannot Undergo Local Surgery and/or Radiotherapy
Study ID: NCT01397877
Conditions
Interventions
Study Description
Brief Summary: This study is to determine the clinical efficacy of BKM120 as monotherapy in the treatment of initial or recurrent metastatic endometrial cancer after first line radio chemotherapy. Clinical efficacy will be determined by the non-progression rate at 3 or 2 months depending on the group of patients. The primary endpoint is the non-progression rate at 3 months (12 weeks) for the patient group whose disease is painless (low grade tumor = stratum 1) and the non-progression rate at 2 months (8 weeks) for the group of patients with an aggressive disease (high grade tumor = stratum 2). Disease progression is defined by the RECIST 1.1 criteria
Detailed Description:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Clinique Bonnefon, Ales, , France
Centre Paul Papin, Angers, , France
Institut Ste Catherine, Avignon, , France
Hôpital jean Minjoz, Besancon, , France
Centre Hospitalier de Blois, Blois, , France
Clinique Tivoli, Bordeaux, , France
Institut Bergonié, Bordeaux, , France
Polyclinique Bordeaux Nord, Bordeaux, , France
centre Francois baclesse, Caen, , France
Centre jean Perrin, Clermont Ferrand, , France
Hôpitaux Civils de Colmar, Colmar, , France
Centre Georges François leclerc, Dijon, , France
Group Hospitalier Mutualiste de Grenoble, Grenoble, , France
Hôpital Michallon - CHU Grenoble, Grenoble, , France
CHD Les Oudairies, la Roche sur Yon, , France
Hôpital André Mignot, Le Chesnay, , France
Centre jean Bernard, Le Mans, , France
Centre Oscar Lambret, Lille, , France
CHU Dupuytren, Limoges, , France
Centre Léon bérard, Lyon, , France
Hôpital Prové Clairval, Marseille, , France
institut Paoli Calmette, Marseille, , France
CRLC Val d'Aurelle, Montpellier, , France
Groupement de coopération sanitaire, Montpellier, , France
Centre Alexis Vautrin, Nancy, , France
Centre d'oncologie de Gentilly, Nancy, , France
Centre Catherine de Sienne, Nantes, , France
Centre Antoine Lacassagne, Nice, , France
CHU Caremeau, Nimes, , France
Clinique Valdegour, Nimes, , France
Centre Hospitalier Régional, Orléans, , France
Hopital Hotel Dieu, Paris, , France
Hopital Tenon, Paris, , France
Centre Eugene Marquis, Rennes, , France
Centre Frederic Joliot, Rouen, , France
Centre Henri Becquerel, Rouen, , France
Clinique Armoricaine de Radiologie, Saint Brieuc, , France
Hôpital rené Huguenin, St Cloud, , France
ICO René Gauducheau, St Herblain, , France
Centre Etienne DOLET, St Nazaire, , France
Institut cancérologuie de la loire, St Priest en Jarez, , France
Hôpital Civil, Strasbourg, , France
Centre Claudius Régaud, Toulouse, , France
CHU Bretonneau, Tours, , France
Institut Gustave Roussy, Villejuif, , France
Contact Details
Name: Isabelle Ray-Coquard, MD
Affiliation: GINECO - Centre Léon Bérard
Role: PRINCIPAL_INVESTIGATOR
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