A Phase 2 Study Of Zanzalintinib For Patients With Recurrent Or Metastatic Olfactory Neuroblastoma
Sponsor: M.D. Anderson Cancer Center
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Safety and Adverse Events (AEs)
Time frame: Through study completion; an average of 1 year
Eligibility Criteria
Inclusion Criteria: All subjects must meet all the following inclusion criteria to be eligible for participation in this study: 1. Subjects ≥18 years with histology-proven R/M ONB. 2. Not amenable to curative intent surgery or radiotherapy 3. Measurable disease per RECIST 1.1 4. Performance status ECOG of 0 or 1 5. VEGFR-inhibitor naïve (R/M ONB never treated with VEGFR inhibitors including Zanzalintinib) 6. Adequate organ and marrow function, based upon meeting all the following laboratory criteria within 14 days before first dose of study treatment 1. Hemoglobin ≥ 9 g/dL without transfusion within 2 weeks prior to screening laboratory sample collection. 2. Absolute neutrophil count ≥ 1500/mm3 (≥ 1.5 GI/L) without granulocyte colony-stimulating factor support within 2 weeks of screening laboratory sample collection. 3. Platelets ≥ 100 x 109/mL without transfusion within 2 weeks of screening laboratory sample collection. 7. Laboratory measurements, renal function: 1. Cr…
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