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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
Must not have
Prior treatment with enzalutamide, TOK-001, or ARN-509
Participants who have received more than two prior chemotherapy regimens for metastatic CRPC
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group

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.
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.
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
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My prostate cancer has spread, as shown on scans.
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My prostate cancer has spread and cannot be surgically removed or cured with standard treatments.
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My prostate cancer is worsening despite hormone therapy.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have previously been treated with enzalutamide, TOK-001, or ARN-509.
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I have had more than two chemotherapy treatments for advanced prostate cancer.
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I have cancer that has spread to my brain.
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I am allergic to medications similar to tivozanib or enzalutamide.
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I haven't had major surgery in the last 4 weeks or minor surgery in the last 2 weeks.
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I have a serious heart condition.
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I cannot take pills properly due to my stomach or bowel issues.
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I do not have a serious infection or one needing IV antibiotics.
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I have a condition or take medication that weakens my immune system.
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I haven't had any major bleeding issues in the last 6 months.
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I have a wound, bone fracture, or skin ulcer that is not healing.

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

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

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
3,013 Previous Clinical Trials
13,309,306 Total Patients Enrolled
35 Trials studying Prostate Cancer
3,673 Patients Enrolled for Prostate Cancer
National Comprehensive Cancer NetworkNETWORK
120 Previous Clinical Trials
8,027 Total Patients Enrolled
6 Trials studying Prostate Cancer
429 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
~0 spots leftby Dec 2025
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