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Antiandrogen

Tivozanib + Enzalutamide for Prostate Cancer

Phase 2
Waitlist Available
Led By M. Dror Michaelson, MD, PhD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Radiographic evidence of metastatic prostate cancer
Adenocarcinoma of the prostate that is metastatic or unresectable and for which standard curative options do not exist
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial is testing whether a combination of two drugs, one of which is already approved to treat prostate cancer, is more effective in delaying the progression of disease than the approved drug used alone. The drugs work in different ways to fight the cancer.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Possible side effects include those related to blocking male hormones like fatigue and hot flashes, as well as risks from preventing tumor blood supply such as high blood pressure, less wound healing, bleeding issues, and digestive problems.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My prostate cancer has spread, as shown on scans.
Select...
My prostate cancer has spread and cannot be surgically removed or cured with standard treatments.
Select...
My prostate cancer is worsening despite hormone therapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression Free Survival
Secondary outcome measures
Overall Survival
PSA Response rate
Safety and Tolerability
+1 more

Trial Design

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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tivozanib
FDA approved
Enzalutamide
FDA approved

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,928 Previous Clinical Trials
13,198,350 Total Patients Enrolled
34 Trials studying Prostate Cancer
2,973 Patients Enrolled for Prostate Cancer
National Comprehensive Cancer NetworkNETWORK
115 Previous Clinical Trials
7,630 Total Patients Enrolled
5 Trials studying Prostate Cancer
396 Patients Enrolled for Prostate Cancer
M. Dror Michaelson, MD, PhDPrincipal InvestigatorMassachusetts General Hospital
3 Previous Clinical Trials
311 Total Patients Enrolled
1 Trials studying Prostate Cancer
239 Patients Enrolled for Prostate Cancer

Media Library

Enzalutamide (Antiandrogen) Clinical Trial Eligibility Overview. Trial Name: NCT01885949 — Phase 2
Prostate Cancer Research Study Groups: Experimental Treatment Arm
Prostate Cancer Clinical Trial 2023: Enzalutamide Highlights & Side Effects. Trial Name: NCT01885949 — Phase 2
Enzalutamide (Antiandrogen) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01885949 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the primary reason for taking Enzalutamide?

"Enzalutamide is typically used to battle disease progression after prior cytokine therapy and can be taken for various purposes like treating advanced renal cell carcinoma (arcc), krn 951, castration."

Answered by AI

Is enrollment still open for this experiment?

"Unfortunately, recruitment for this trial has ceased. It was first posted on September 3rd 2013 and its last update occured on October 25th 2021. However, there are a total of 1422 active clinical trials related to prostate cancer and Enzalutamide which may still be available to join."

Answered by AI

What prior studies have been conducted with Enzalutamide?

"Presently, 101 studies are running for Enzalutamide with 31 of them in their third phase. Most trials are occurring out of Germantown, Tennessee but 5941 other sites also have active clinical research underway."

Answered by AI

Are there known risks associated with Enzalutamide use?

"Based on the data available, our team at Power gave Enzalutamide a safety rating of 2. This is because while there is some evidence of its security, no clinical studies have been conducted to assess efficacy yet."

Answered by AI

How many participants are contributing to this research endeavor?

"Unfortunately, no more candidates are being accepted for this medical trial. It was originally listed on September 3rd 2013 and last edited October 25th 2021. However, if you're looking into other studies related to prostate cancer there are 1321 active trials currently recruiting patients, with 101 of those pertaining specifically to Enzalutamide treatment."

Answered by AI
~1 spots leftby Dec 2025