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Spots Global Cancer Trial Database for A Phase II Study Evaluating Efficacy and Safety of Regorafenib in Patients With Metastatic Bone Sarcomas

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Trial Identification

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

Interventions

Regorafenib
Placebo

Study Description

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 .

Keywords

Eligibility

Minimum Age: 10 Years

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Florence DUFFAUD, MD PhD

Affiliation: La Timone University Hospital

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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