30 Participants NeededMy employer runs this trial

Zanzalintinib for Prostate Cancer

(NAPOLEON Trial)

DK
AL
Overseen ByAllison Lipps
Age: 18+
Sex: Male
Trial Phase: Phase 2
Sponsor: Deepak Kilari
Must be taking: GnRH agonist/antagonist
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human 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?

DK

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

I have had both testicles removed or am on hormone therapy with low testosterone levels.
I am 18 years old or older.
I have been diagnosed with prostate cancer by a tissue or cell test.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive zanzalintinib 60mg orally once daily until radiographic progression, intolerable adverse events, or withdrawal of consent

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 years

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

Group I: ZanzalintinibExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Deepak Kilari

Lead Sponsor

Trials
1
Recruited
50+

Medical College of Wisconsin

Collaborator

Trials
645
Recruited
1,180,000+

Exelixis

Industry Sponsor

Trials
126
Recruited
20,500+
Michael M. Morrissey profile image

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 profile image

Vicki L. Goodman

Exelixis

Chief Medical Officer since 2022

MD

Citations

Press Release - Exelixis, Inc.

Zanzalintinib in combination with nivolumab demonstrated an objective response rate of 63% and a disease control rate of 90% Median progression ...

Zanzalintinib 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 ...

Zanzalitinib 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.