Zanzalintinib in Men With Aggressive Variant Prostate Cancer
Phase II Study of Zanzalintinib in Men With Aggressive Variant Prostate Cancer (NAPOLEON Study)
Sponsor: Deepak Kilari + Exelixis, Medical College of Wisconsin
No open prediction endpoints
Endpoints are classified and published by ProgramSignal analysts.
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Primary Endpoints (CT.gov)
Radiographic progression free survival (rPFS)
Time frame: 6 months
Radiographic progression free survival (rPFS)
Time frame: 6 months
Secondary Endpoints
Adverse Events
Overall Survival
Objective response rate (ORR)
Eligibility Criteria
Inclusion Criteria: 1. 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. 2. Age ≥ 18 years at the time of consent. 3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2 within 14 days prior to registration. 4. Histological or cytologically proven prostate cancer 5. Must have had evidence of metastatic disease (AJCC v.8 M1 disease) based on conventional CT/MRI and/or bone scan. This will be defined as: * Bone metastases detected by CT, radionuclide 99Tc- methylene bisphosphonate bone scan, or MRI as defined by PCWG3 criteria, OR * Non-pelvic lymph node metastases (measurable lymph nodes above the aortic bifurcation; lymph nodes are measurable if the short axis diameter is ≥15 mm) detected on CT or MRI as defined by RECIST version 1.1. Subjects with regional lymph node metastases only (N1, below the aortic bifu…
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Expert commentary on why this trial matters and what to watch for.
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