A Phase 2 Trial of Zanzalintinib in Advanced/Metastatic Bone Sarcomas (ZAMBONE)
M.D. Anderson Cancer Center
Summary
To study the treatment efficacy of zanzalintinib monotherapy in patients with advanced and/or metastatic bone sarcomas.
Description
Primary Objectives: * For cohort A (osteosarcoma) progression-free survival (PFS) rate at 16 weeks (PFS16 weeks) * For cohort B (Ewing sarcoma), cohort C (chondrosarcoma), and cohort D (other bone sarcomas), progression-free survival (PFS) at 12 weeks (PFS12 weeks). Secondary Objectives: * To estimate the objective response rate (ORR) within each cohort by RECIST 1.1 criteria. * To estimate the progression-free survival (PFS) and overall survival in patients with locally advanced or metastatic bone sarcomas receiving zanzalintinib. * To evaluate the safety and tolerability of zanzalintinib…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: • Patients ≥ 18 years old with pathologically confirmed unresectable locally advanced or metastatic bone sarcoma in one of the following categories: Cohort A - Osteosarcoma, Cohort B - Ewing sarcoma, Cohort C - Chondrosarcoma (conventional, grades 2-3), Cohort D - Other primary sarcoma of bone including but not limited to dedifferentiated chondrosarcoma, undifferentiated pleomorphic sarcoma (UPS) of bone, chordoma, and non-Ewing's round cell sarcomas of bone. chondrosarcoma, undifferentiated pleomorphic sarcoma (UPS) of bone, chordoma, and non-Ewing's round cell sarcomas…
Interventions
- DrugZanzalintinib
Participants will take zanzalintinib 100mg daily by mouth
Location
- The University of Texas M. D. Anderson Cancer CenterHouston, Texas