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Brief Title: A Phase II Study Evaluating Efficacy and Safety of Regorafenib in Patients With Metastatic Bone Sarcomas
Official Title: A Randomized Phase II, Placebo-controlled, Multicenter Study Evaluating Efficacy and Safety of Regorafenib in Patients With Metastatic Bone Sarcomas
Study ID: NCT02389244
Brief Summary: INDICATION: Metastatic bone sarcomas: conventional high grade osteosarcoma, Ewing sarcoma of bone, intermediate or high-grade chondrosarcomas and chordomas and either bone or soft tissue metastatic CIC-rearranged sarcomas
Detailed Description: METHODOLOGY: Randomized, placebo-controlled, multicentric, phase II study -This is a double-blind placebo-controlled trial, with 5 cohorts: cohort A: Osteosarcoma, cohort B: Ewing sarcoma, cohort C: Chondrosarcoma, cohort D : chondroma, cohort E: CIC-rearranged sarcoma. Cohort A, B and C will involve a total of 36 patients (24 Regorafenib + 12 placebo), cohort D a total of 24 evaluable patients (16 Regorafenib + 8 placebo) and cohort E will involve a total of 27 evaluable patients (18 Regorafenib + 9 placebo). 159 patients who meet the eligibility criteria will be randomly assigned in a 2:1 ratio to the following treatment groups : The Arm A: Regorafenib (160 mg/d) once daily for the 3 weeks on / 1 week off plus Best Supportive Care (BSC) until progression (according to RECIST 1.1), intolerance or withdrawal of consent . Patients receiving regorafenib who experience disease progression and for whom in the investigator opinion, treatment with regorafenib is providing clinical benefit, may continue the treatment following consultation with the study coordinator and the sponsor. The Arm B: Placebo plus BSC until progression (according to RECIST V1.1) intolerance or withdrawal of consent. Patients who have received placebo will receive open-label regorafenib after objective tumor progression. Patients will be stratified at randomization according to histology .
Minimum Age: 10 Years
Eligible Ages: CHILD, ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Hopital Jean Monjoz, Besancon, , France
Institut Bergonie, Bordeaux, , France
Centre Francois Baclesse, Caen, , France
Centre Georges Francois Leclerc, Dijon, , France
Centre Oscar Lambret, Lille, , France
Centre Léon Berard, Lyon, , France
Institut Paoli Calmettes, Marseille, , France
La Timone University Hospital, Marseille, , France
ICM Val d'Aurelle, Montpellier, , France
Centre Antoine Lacassagne, Nice, , France
Hôpital Cochin, Paris, , France
Institut Curie, Paris, , France
Centre Eugene Marquis, Rennes, , France
Institut de cancerologie de l'ouest site Rene Gauducheau, Saint Herblain, , France
Institut de Cancérologie Lucien Neuwirth (ICLN), Saint Priest en Jarez, , France
Institut Claudius Regaud, Toulouse, , France
CHU Bretonneau, Tours, , France
Institut de cancerologie de lorraine alexis Vautrin, Vandoeuvre les Nancy, , France
Gustave Roussy, Villejuif, , France
Name: Florence DUFFAUD, MD PhD
Affiliation: La Timone University Hospital
Role: PRINCIPAL_INVESTIGATOR