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 @ 4:17 PM
Ignite Modification Date:
2025-12-24 @ 4:17 PM
NCT ID:
NCT06937866
Brief Summary:
This is an open label, single arm phase I/II trial of maintenance zanzalintinib in combination with oral etoposide in patients with relapsed GCT treated with HDCT and PBSCT with a safety lead-in cohort in patients with relapsed, refractory metastatic GCT.
Detailed Description:
This prospective, phase I/II trial will initially enroll 9 patients with relapsed, refractory metastatic disease. Two doses of zanzalintinib will be evaluated for toxicity. The patients will receive zanzalintinib orally daily continuously in combination with oral standard of care etoposide daily for 21 days out of 28 day cycles until time of progression or toxicity. The DLT period is 1 cycle of 28 days. We will employ the Bayesian optimal interval (BOIN) design to find the MTD.
Study:
NCT06937866
Study Brief:
Protocol Section:
NCT06937866