Enzalutamide + Cabazitaxel for Prostate Cancer

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen byJulie N Graff

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: OHSU Knight Cancer Institute

No Placebo Group

Trial Summary

What is the purpose of this trial?This phase I/II trial studies the side effects and best dose of cabazitaxel when given together with enzalutamide in treating patients with prostate cancer that has spread to other places in the body (metastatic) and has not responded to treatment with hormones or no longer responds to treatment with hormones (hormone-resistant). Drugs used in chemotherapy, such as cabazitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Androgen can cause the growth of prostate cancer cells. Hormone therapy using enzalutamide may fight prostate cancer by blocking the use of androgen by the tumor cells. Giving cabazitaxel together with enzalutamide may work better in treating metastatic, hormone-resistant prostate cancer.

Eligibility Criteria

This trial is for men with metastatic, hormone-resistant prostate cancer. Participants must have a good performance status (able to carry out daily activities), adequate blood counts and organ function, agree to use double barrier contraception, and be willing to provide a tumor sample if possible. Men who've had certain treatments or have specific health conditions are excluded.

Inclusion Criteria

My testosterone levels are low due to treatment or surgery.

I agree to provide a tumor sample if it's safe and possible, or I have an existing sample.

My prostate cancer is getting worse, shown by tests or symptoms.

+21 more

Exclusion Criteria

I have never taken enzalutamide or ARN-509.

I haven't taken any experimental drugs in the last 14 days.

I have a history of seizures or conditions that could lead to seizures.

+11 more

Participant Groups

The study tests the combination of cabazitaxel (a chemotherapy drug) and enzalutamide (a hormone therapy) on patients with advanced prostate cancer that's spread and doesn't respond to hormonal treatment anymore. The phase I/II trial aims to find the best dose of cabazitaxel when used with enzalutamide.

1Treatment groups

Experimental Treatment

Group I: Treatment (cabazitaxel, enzalutamide)Experimental Treatment5 Interventions

Patients receive cabazitaxel IV over 1 hour on day 1 and enzalutamide PO QD on days 1-21 (days 2-21 of cycle 1). Patients also receive prednisone PO BID as standard of care with cabazitaxel. Cycles repeat every 21 days for 6-10 cycles in the absence of disease progression or unacceptable toxicity. Patients may continue enzalutamide PO QD on days 1-28 in the absence of disease progression or unacceptable toxicity.

Cabazitaxel is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Jevtana for: