Zanzalintinib for Prostate Cancer
(NAPOLEON Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called zanzalintinib to evaluate its effectiveness against a specific type of advanced prostate cancer. The goal is to determine how well the drug slows or stops tumor growth in patients whose cancer has spread. Patients with metastatic prostate cancer, who have tried other treatments without success, and have specific conditions like certain types of cancer spread or genetic changes, might be suitable for this study. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering a chance to contribute to important advancements in cancer care.
Is there any evidence suggesting that zanzalintinib is likely to be safe for humans?
Research has shown that Zanzalintinib is generally well-tolerated by patients with advanced prostate cancer. In earlier studies, patients reported few serious side effects. Although all treatments can cause side effects, available information suggests that these effects are manageable for most people. This indicates that while some individuals might experience mild discomfort, the treatment remains safe enough for further testing. Participants in previous studies demonstrated that Zanzalintinib could be a promising option for those whose cancer no longer responds to hormone therapy.12345
Why do researchers think this study treatment might be promising for prostate cancer?
Zanzalintinib is unique because it targets aggressive variants of prostate cancer (AVPC) with a fresh approach. While most current treatments for prostate cancer, such as hormone therapy and chemotherapy, focus on reducing hormone levels or killing rapidly dividing cells, Zanzalintinib works differently. It is designed to be taken orally once daily and aims to interfere with specific pathways that contribute to the aggressive behavior of these cancer cells. Researchers are excited about Zanzalintinib because its novel mechanism of action could offer more precise treatment with potentially fewer side effects, providing hope for better outcomes in patients with aggressive forms of prostate cancer.
What evidence suggests that zanzalintinib might be an effective treatment for prostate cancer?
Research has shown that zanzalintinib, the treatment under study in this trial, may help treat advanced prostate cancer. It has proven effective for patients whose cancer no longer responds to hormone therapy, and studies indicate it is generally well-tolerated. In trials where zanzalintinib was combined with other drugs, it achieved high success rates, including a 63% response rate in other cancer types. This suggests it might help slow the disease's progression. Zanzalintinib targets cancer cells to stop them from growing and spreading. These early findings are promising for its use in prostate cancer, but further research is needed to confirm these benefits.24678
Who Is on the Research Team?
Deepak Kilari, MD
Principal Investigator
Medical College of Wisconsin
Are You a Good Fit for This Trial?
This trial is for men aged 18 or older with aggressive variant prostate cancer that has spread to bones, lymph nodes (outside the pelvis), or other organs. Participants must have low testosterone due to ongoing hormone therapy or surgery and have already tried at least one advanced hormone treatment.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive zanzalintinib 60mg orally once daily until radiographic progression, intolerable adverse events, or withdrawal of consent
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Zanzalintinib
Trial Overview
The study tests zanzalintinib, taken as a daily pill, in men with aggressive prostate cancer. All participants receive this drug until their cancer worsens significantly or they experience side effects that are too severe.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Zanzalintinib 60mg orally (PO) will be given once daily in subjects with AVPC.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Deepak Kilari
Lead Sponsor
Medical College of Wisconsin
Collaborator
Exelixis
Industry Sponsor
Michael M. Morrissey
Exelixis
Chief Executive Officer since 2010
PhD in Chemistry from Harvard University, BSc in Chemistry from the University of Wisconsin
Vicki L. Goodman
Exelixis
Chief Medical Officer since 2022
MD
Citations
1.
ir.exelixis.com
ir.exelixis.com/news-releases/news-release-details/exelixis-announces-encouraging-results-phase-1b2-stellar-002Press Release - Exelixis, Inc.
Zanzalintinib in combination with nivolumab demonstrated an objective response rate of 63% and a disease control rate of 90% Median progression ...
2.
urologytimes.com
urologytimes.com/view/zanzalintinib-plus-nivolumab-shows-safety-efficacy-for-stage-4-rccZanzalintinib plus nivolumab shows safety, efficacy for ...
Zanzalintinib and nivolumab showed a 63% response rate and 18.5-month median PFS in stage 4 RCC. The study included patients with advanced RCC, ...
A "historic achievement" for the majority of patients with mCRC ...
While the study showed no difference in overall survival, BUTetium had a significantly higher response rate and toxicity compared to Docetaxel.
NCT05176483 | Study of Zanzalintinib in Combination With ...
This is a multicenter Phase 1b, open label, dose-escalation and cohort-expansion study, evaluating the safety, tolerability, pharmacokinetics (PK), ...
STELLAR 303: Trial Design and Efficacy Outcomes of ...
In the intention-to-treat population, median overall survival was approximately 11 months with zanzalintinib plus atezolizumab versus 9.4 months ...
PRO-XL: A phase II study of zanzalintinib (XL092) in ...
Thirty patients will ensure that the disease control rate can be estimated. Secondary Endpoints: safety, tolerability, PSA 50% response rate, ...
Study of Zanzalintinib in Combination With Immuno ...
The trial is open to men with advanced prostate cancer that has spread and worsened after treatment with standard hormone therapies. To be eligible, patients ...
8.
withpower.com
withpower.com/trial/phase-2-metastatic-castration-resistant-prostate-cancer-8-2026-24398Zanzalitinib for Prostate Cancer · Info for Participants
Research has shown that Zanzalintinib is generally well-tolerated in patients with advanced prostate cancer that no longer responds to hormone therapy.
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