Maintenance Zanzalintinib With Etoposide After HDCT in GCT
ConditionGerm Cell Tumor
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorIndiana University
About this trial
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.
Eligibility criteria
Qualifiers
Histological or serological evidence of incurable, refractory or relapsed metastatic germ cell tumor, including seminoma, non-seminoma, and women with ovarian GCTs.
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.
Subjects with relapsed primary mediastinal non-seminomatous germ-cell tumor (PMNSGCT) or late relapse (>2 years) not amenable to resection are eligible if they have received first line platinum-based chemotherapy and are deemed not amenable to surgical resection.
Histological or serological evidence of non-seminomatous GCT
Disqualifiers
Relapsed pure seminoma
Rising tumor markers (AFP and hCG) at time of screening per discretion of treating physician
Patients who completed 2nd cycle of HDCT (time since last dose of HDCT) > 16 weeks ago
Prior treatment with zanzalintinib
Trial design
Treatments tested in this trial
- Zanzalintinib
- Etoposide Capsule
Treatment groups
38 Participants
are divided into 2 treatment groupsSponsors and collaborators
Indiana University
Lead sponsor
Exelixis
Collaborator
Source ClinicalTrials.gov