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Zanzalintinib in Men With Aggressive Variant Prostate Cancer

NCT07218666 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-10-21

No results posted yet for this study

Summary

This is a multi-center single arm phase II study to evaluate the antitumor activity of zanzalintinib 60mg orally (PO) once daily in subjects with AVPC. Zanzalintinib may continue until radiographic progression (or beyond), intolerable adverse events, or withdrawal of consent. As long as the subject is clinically stable, subjects may receive study treatment even after radiographic progression, until they are no longer clinically benefiting from the study treatment in the opinion of the treating Investigator, or they need subsequent systemic anticancer treatment or other urgent tumor directed medical intervention to prevent life-threatening complications.

This study will use a 2-stage group-sequential design for enrollment. The first stage will consist of enrolling 15 subjects. No more than 5 of the first 15 subjects can have received chemotherapy in the castrate- resistant setting.

Conditions

  • Aggressive Variant Prostate Carcinoma

Interventions

DRUG

Zanzalintinib

Zanzalintinib 60mg orally (PO) once daily in

Sponsors & Collaborators

  • Exelixis

    collaborator INDUSTRY

  • Medical College of Wisconsin

    collaborator OTHER

  • Deepak Kilari

    lead OTHER

Principal Investigators

  • Deepak Kilari, MD · Medical College of Wisconsin

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2026-12-31
Completion
2027-12-31
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07218666 on ClinicalTrials.gov