AOST2032. A Feasibility and Randomized Phase 2/3 Study of the VEFGR2/MET Inhibitor Cabozantinib in Combination with Cytotoxic Chemotherapy for Newly Diagnosed Osteosarcoma.
Categories (click each to see list of all clinical trials associated with that category): Pediatric (PEDONC)
Current Status: Open
Phase: II/III (Cancer Control)
Principal Investigator: Beck, Jill
Contact Information:
Angie Boettner
aboettner@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT05691478?term=NCT05691478&rank=1
Summary
Primary Outcome Measures :
1. Occurrence of dose-limiting toxicity (DLT) (Feasibility) [ Time Frame: Baseline up to 6 weeks ]
Only patients with high risk osteosarcoma who have a primary tumor considered resectable at the time of enrollment will be enrolled to this part of the trial. If a feasible dose cannot be established, the study committee will consult with Children's Oncology Group (COG) leadership and National Cancer Institute Cancer Therapy Evaluation Program (NCI CTEP) regarding possible modifications of the regimen and subsequent protocol amendment.
Secondary Outcome Measures :
1. Event-free survival (EFS) (Phase II) [ Time Frame: From randomization until disease progression, relapse, diagnosis of a second malignant neoplasm, death or last contact, whichever occurs first, assessed up to 5 years after completion of study treatment ]
The randomization and analysis will be stratified according to risk group. An assessment of the reduction in risk for EFS-event at the designated landmark time will be used to determine whether the trial continues to part 3. If the study proceeds to part 3, patients enrolled to part 2 of the trial will contribute to the primary analyses for part 3 of the study. If the interim criterion for continuation is not obtained, accrual will be closed with the conclusion that cabozantinib does not reduce sufficiently the risk for EFS-event for patients with newly-diagnosed osteosarcoma.
2. Event-free survival (EFS) (Phase III) [ Time Frame: From randomization until disease progression, relapse, diagnosis of a second malignant neoplasm, death or last contact, whichever occurs first, assessed up to 5 years after completion of study treatment ]
Will consist of two randomized phase 3 sub-studies ('Phase 3'). One will be conducted in standard risk patients and one will be conducted in high risk patients.
3. Overall survival (OS) [ Time Frame: From randomization until death or last contact, whichever occurs first, assessed up to 5 years after completion of study treatment ]