Maintenance Zanzalintinib With Oral Etoposide Following High-dose Chemotherapy in Patients With Relapsed Metastatic Germ-cell Tumor
Indiana University
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.
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Phase I: 1. Histological or serological evidence of incurable, refractory or relapsed metastatic germ cell tumor, including seminoma, non-seminoma, and women with ovarian GCTs. 2. Must have received initial cisplatin-based combination chemotherapy AND demonstrated progression following at least one salvage regimen for advanced germ-cell neoplasm and now considered incurable with standard therapies, including further chemotherapy or surgery. 2.1. "Failure" of prior therapy is defined as: 2.1.1.A \>25% increase in the products of the perpendicular diameters of measurabl…
Interventions
- DrugZanzalintinib
Two zanzalintinib doses of 40mg and 60mg. The initial starting dose of zanzalintinib will be 40mg. The patients will receive zanzalintinib orally daily continuously for 28 day cycles.
- DrugEtoposide Capsule
Oral daily for 21 days of each 28 day cycle.
Location
- Indiana University Melvin and Bren Simon Comprehensive Cancer CenterIndianapolis, Indiana