← Back to results
NCT07218666PHASE2NOT_YET_RECRUITING

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.

Request endpoint coverage

Key Facts

Study type
INTERVENTIONAL
Conditions
Aggressive Variant Prostate Carcinoma
Interventions
Zanzalintinib
Enrollment
30 participants
Primary completion
Dec 2026
Study completion
Dec 2027
First posted
Oct 2025
Last updated
Oct 2025

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

Read full criteria on CT.gov →

✦ Analyst Commentary

Expert commentary on why this trial matters and what to watch for.

Request coverage →

Source

Open on ClinicalTrials.gov