Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:00 PM
Ignite Modification Date:
2025-12-24 @ 5:00 PM
NCT ID:
NCT07193550
Brief Summary:
To study the treatment efficacy of zanzalintinib monotherapy in patients with advanced and/or metastatic bone sarcomas.
Detailed 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 within each cohort and across cohorts as assessed by toxicity rates according to CTCAE version 5.0 criteria.
Exploratory Objectives:
To determine the expression of selected biomarkers in pre-treatment and on-treatment tumor biopsy specimens and correlate with clinical benefit within each cohort and across cohorts
Study:
NCT07193550
Study Brief:
Protocol Section:
NCT07193550