CabOSTar_Effects of Maintenance Cabozantinib+BSC Versus BSC in Children and AYA With Osteosarcoma

{ "short_title": "CabOSTar_Effects of Maintenance Cabozantinib+BSC Versus BSC in Children and AYA With Osteosarcoma", "data_mode": "900", "data_mode_number": "000002485", "official_title": "A Phase II, Randomized, Open-label Study to Assess the Efficacy, Safety, and Pharmacokinetics (PK) of Maintenance Cabozantinib (XL184) Plus Best Supportive Care (BSC) Versus BSC in Children, Adolescents and Young Adults (AYA) With Unresectable Residual Osteosarcoma Either at Diagnosis or at First Relapse After Standard Treatment", "accrual_state": "running", "therapeutic_value": null, "therapieansatz_value": null, "therapieintervention_value": null, "therapielinie_value": null, "ctgov_number": "NCT06341712", "eudract_number": null, "general_contact_email": "oncostudy@ukdd.de", "general_contact_phone": "+49 351-4587666", "hauptpruefer_dd_name": "Dr. med. Stephan Richter", "description_laie_de": null, "description_laie_en": null, "description_expert_de": null, "description_expert_en": "The participants of this study will be children, adolescents, and young adults withresidual osteosarcoma, which cannot be removed completely through surgery.Participants will have achieved a partial response or stable disease at the end ofconventional chemotherapy. Osteosarcoma is cancer of the bone. The cancer cells makeimmature bone cells, known as osteoid.Osteosarcoma is very rare, but it is the most common type of bone cancer in children andteens. It is most common in teens and young adults.In this study, participants will receive either cabozantinib and best supportive care orthe best supportive care alone. Best supportive care will be provided at theinvestigator's discretion and according to institutional guidelines.It includes antibiotics, nutritional support, correction of metabolic disorders, optimalsymptom control and pain management (including radiotherapy), etc. but does not includetumor specific therapy.Cabozantinib will be taken by mouth (orally), as a tablet, once a day", "rechtsgrundlage_value": "AMG", "phase_amg_value": "II", "main_cat_id": 9, "sub_cat_id": 45 }