Zanzalintinib for Advanced Urothelial Carcinoma Progressing After Prior Therapy
ConditionAdvanced Urothelial Carcinoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorGuru Sonpavde
About this trial
This is a Phase II, single arm study. All subjects will receive Zanzalintinib 60 mg orally once daily until progression per RECIST 1.1 or intolerable toxicities or patient/investigator decision to discontinue study therapy. Radiology imaging will be performed every 8 weeks for 3 timepoints then every 12 weeks thereafter. A window of ± 7 days may be applied to all study visits to accommodate observed holidays, inclement weather, scheduling conflicts etc.
Eligibility criteria
Qualifiers
Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
Age ≥ 18 years at the time of consent.
Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2 within 28 days prior to registration.
Histologically confirmed predominant urothelial carcinoma (T4b, N0, M0; any T, N1-N3, M0; any T, any N, M1). American Joint Committee on Cancer (AJCC) v8 staging manual. NOTE: must be locally advanced unresectable or metastatic.
Disqualifiers
More than 3 lines of prior therapy (prior cisplatin-based perioperative chemotherapy within 1 year prior to subsequent therapy or registration, whichever comes first) and/or prior perioperative PD1 inhibitor within 12 weeks prior to subsequent therapy (or registration, whichever comes first) is considered a line of therapy).
Prior receipt of a VEGF inhibitor.
Prior receipt of zanzalintinib.
Receipt of any type of small molecule kinase inhibitor (including investigational kinase inhibitor) within 28 days before registration.
Trial design
Treatments tested in this trial
- Zanzalintinib
Treatment groups
44 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Guru Sonpavde
Lead sponsor
Hoosier Cancer Research Network
Sponsor institution
Exelixis
Collaborator
Advent Health
Collaborator
Source ClinicalTrials.gov