Tivozanib + Enzalutamide for Prostate Cancer

Recruiting in Palo Alto (17 mi)

Overseen byDror Michaelson, MD

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Massachusetts General Hospital

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This research study is a Phase II clinical trial, which tests the safety and effectiveness of an investigational combination of drugs to learn whether they work in treating a specific cancer. "Investigational" means that the combination of drugs is still being studied and that research doctors are trying to find out more about it, such as the safest dose to use and the side effects they may cause. It also means that the FDA has not yet approved the combination. The two drugs being tested in this study are tivozanib and enzalutamide. Enzalutamide has been approved by the FDA for treatment of prostate cancer. On the other hand, tivozanib is still investigational, and has not been tested in a combination with enzalutamide before. Enzalutamide is an androgen receptor antagonist (it blocks the activity of the male sex hormones). Prostate cancers are initially dependent on the male hormone testosterone for growth. Hormonal therapies that lower testosterone or block the ability of testosterone to act at the level of the prostate cancer are currently among the most effective treatments for prostate cancers taht have spread to other body organs (metastasized). The effectiveness of hormonal treatments, however, is not permanent, and over time many prostate cancers progress in spite of these treatments. Enzalutamide is a drug that has been proven to help delay the progression of advanced prostate cancer on average for about 8 months. Tivozanib is an anti-angiogenesis medicine that fights different types of cancer by blocking the blood supply to the tumor, so that the tumor does not receive the nutrients it needs to grow. The main goal of this study is to determine whether the combination of tivozanib and enzalutamide is more effective in delaying the progression of disease than when enzalutamide is given alone. This study will also determine whether treatment with the combination of the tivozanib and enzalutamide will have more side effects then treatment with enzalutamide alone.

Eligibility Criteria

Men with metastatic prostate cancer that's resistant to hormone therapy and have had docetaxel-based chemotherapy in the past year can join. They must be able to swallow capsules, not have a major illness or surgery recently, no active infections or second cancers (except certain skin/breast cancers), and agree to use contraception.

Inclusion Criteria

Life expectancy of at least 12 weeks

Must agree to use adequate contraception prior to study entry and for the duration of study participation

My prostate cancer has spread, as shown on scans.

+4 more

Exclusion Criteria

Receiving any other investigational anticancer agents

I have previously been treated with enzalutamide, TOK-001, or ARN-509.

I have had more than two chemotherapy treatments for advanced prostate cancer.

+14 more

Participant Groups

The trial is testing if combining tivozanib (a drug that cuts off blood supply to tumors) with enzalutamide (an FDA-approved drug for prostate cancer) is more effective than enzalutamide alone in slowing down cancer progression.

1Treatment groups

Experimental Treatment

Group I: Experimental Treatment ArmExperimental Treatment2 Interventions

Tivozanib, taken daily for 21 days followed by a 7 day break Enzalutamide taken daily for 28 days

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

🇺🇸 Approved in United States as Xtandi for: