Prostate CancerPhase 2NCT01885949
Tivozanib + Enzalutamide in Adv Prostate Cancer
A Phase 2 study testing Tivozanib and Enzalutamide in people with Prostate Cancer, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Tivozanib and Enzalutamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Sep 2013to 23 May 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adenocarcinoma of the prostate that is metastatic or unresectable and for which standard curative options do not exist
- Radiographic evidence of metastatic prostate cancer
- Progressive disease despite ongoing androgen deprivation therapy (ADT), defined as castration resistant prostate cancer (CRPC)
- Other than ongoing prior treatment with other hormonal agents such as antiandrogens or ketoconazole must have been stopped at least two weeks prior to enrollment
- Have received prior docetaxel-based chemotherapy for prostate cancer within the past 12 months. Such chemotherapy must have been stopped at least 3 weeks prior to the first dosing in this study
- Life expectancy of at least 12 weeks
- Must agree to use adequate contraception prior to study entry and for the duration of study participation
Who cannot join
- Prior treatment with enzalutamide, TOK-001, or ARN-509
- Participants who have received more than two prior chemotherapy regimens for metastatic CRPC
- Receiving any other investigational anticancer agents
- Known brain metastases
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to tivozanib or enzalutamide
- Radiotherapy or minor surgical procedure within 2 weeks, or major surgical procedure within 4 weeks prior to administration of first dose of study drug; inadequate recovery from prior surgical procedure
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- History of seizure of condition that may predispose to seizure
- Significant cardiovascular disease
- Non-healing wound, bone fracture or skin ulcer
- Active peptic ulcer disease, inflammatory bowel disease, ulcerative colitis or other gastrointestinal condition with increased risk of perforation; history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 4 weeks prior to administration of first dose of study drug
- Serious/active infection or infection requiring parenteral antibiotics
- Significant thromboembolic or vascular disorders within 6 months prior to administration of first dose of study drug
- Currently active second primary malignancy, including hematologic malignancies, except for non-melanoma skin cancers, in situ cervical cancer, and ductal or lobular carcinoma in situ of the breast
- History of genetic or acquired immune suppression disease such as HIV; subjects on immune suppressive therapy for organ transplant
- Inability to swallow capsules, malabsorption syndrome or gastrointestinal disease that severly affects the absorption of study drugs, major resection of the stomach or small bowel, or gastric bypass procedure
- Significant bleeding disorders within 6 months prior to administration of first dose of study drug
- Psychiatric disorder or altered mental status precluding informed consent or protocol-related testing
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Phase 2 Combination Trial of Tivozanib and Enzalutamide in Men With Advanced Prostate Cancer
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.
Read more
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.
Read the detailed description
Patients will be treated in treatment cycles of 28 days (4 weeks), during which time they will take tivozanib once a day for 21 days (3 weeks) followed by a one week break from treatment. The other medication, enzalutamide, will be taken every day throughout each cycle.
Patients will be given a Study Drug Administration Diary to keep a brief record of medication administration, and to record any side effects or symptoms.
Patients will be seen in the clinic at the beginning of each cycle (every 4 weeks). During each visit they will have the following procedures: medical history, vital sign measurements, complete physical examination, performance status, routine blood tests, urine sample, prostate specific antigen (PSA) test, assessment of tumor, review of study drug administration diary, and review of current medications.
About four weeks after stopping the study drug patients will be asked to return to the research clinic for a final study visit. The following procedures will be done: medical history, vital sign measurements, brief physical examination, electrocardiogram, review of other medications used since the last visit, routine blood tests, urine sample and a review of any changes in health.
- Conditions
- Prostate Cancer
- Being tested
- Tivozanib, Enzalutamide
- Keywords
- Metastatic
- Medical subject headings
- Prostatic Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TivozanibDrug
Also called AV-951
Oral
EnzalutamideDrug
Also called MDV-3100
oral
| Study group | Role | What they receive |
|---|---|---|
| Experimental Treatment Arm | Experimental | Tivozanib, taken daily for 21 days followed by a 7 day break Enzalutamide taken daily for 28 days Receives: Drug: Tivozanib; Drug: Enzalutamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival
The primary objective of this study will be to demonstrate an improvement in progression free survival in men with metastatic castration resistant prostate cancer (mCRPC) treated with tivozanib and enzalutamide.
Measured: 2 years
Secondary outcomes (4)
Safety and Tolerability
Safety and tolerability of tivozanib and enzalutamide will be assessed. The number of patients having grades 1-4 adverse events by NCI CTC version 4.0 will be recorded.
Measured: 2 years
Overall Survival
To estimate overall survival in patients treated with tivozanib and enzalutamide
Measured: 2 years
PSA Response Rate
To evaluate PSA response rate
Measured: 2 years
Time to PSA Progression
The time to PSA progression (in months) will be evaluated in patients treated with enzalutamide and tivozanib
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2013 (estimated)
- Study start3 Sep 2013
- Primary completion23 May 2024
- Study completion23 May 2024
Why it stopped: Slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Comprehensive Cancer Network
- Responsible party
- Principal investigator, Dror Michaelson, MD, Massachusetts General Hospital
- Investigators
- M. Dror Michaelson, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01885949
- Sponsor's protocol ID
- 13-073
- Status last verified
- May 2026
- First submitted
- 19 Jun 2013
- Last updated
- 20 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Combination Trial of Tivozanib and Enzalutamide in Men With Advanced Prostate Cancer
- ClinicalTrials.gov ID
- NCT01885949
- Acronym / sponsor ID
- 13-073
- Conditions
- Prostate Cancer
- Keywords
- Metastatic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- National Comprehensive Cancer Network
- Study start
- 3 Sep 2013 (actual)
- Primary completion
- 23 May 2024 (actual)
- Study completion
- 23 May 2024 (actual)
- First posted
- 25 Jun 2013 (estimated)
- Results
- Posted 16 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Patients will be treated in treatment cycles of 28 days (4 weeks), during which time they will take tivozanib once a day for 21 days (3 weeks) followed by a one week break from treatment. The other medication, enzalutamide, will be taken every day throughout each cycle.
Patients will be given a Study Drug Administration Diary to keep a brief record of medication administration, and to record any side effects or symptoms.
Patients will be seen in the clinic at the beginning of each cycle (every 4 weeks). During each visit they will have the following procedures: medical history, vital sign measurements, complete physical examination, performance status, routine blood tests, urine sample, prostate specific antigen (PSA) test, assessment of tumor, review of study drug administration diary, and review of current medications.
About four weeks after stopping the study drug patients will be asked to return to the research clinic for a final study visit. The following procedures will be done: medical history, vital sign measurements, brief physical examination, electrocardiogram, review of other medications used since the last visit, routine blood tests, urine sample and a review of any changes in health.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Treatment Arm | Experimental | Drug: Tivozanib, Drug: EnzalutamideTivozanib, taken daily for 21 days followed by a 7 day break Enzalutamide taken daily for 28 days |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adenocarcinoma of the prostate that is metastatic or unresectable and for which standard curative options do not exist
- Radiographic evidence of metastatic prostate cancer
- Progressive disease despite ongoing androgen deprivation therapy (ADT), defined as castration resistant prostate cancer (CRPC)
- Other than ongoing prior treatment with other hormonal agents such as antiandrogens or ketoconazole must have been stopped at least two weeks prior to enrollment
- Have received prior docetaxel-based chemotherapy for prostate cancer within the past 12 months. Such chemotherapy must have been stopped at least 3 weeks prior to the first dosing in this study
Key exclusion criteria (17 listed)
- Prior treatment with enzalutamide, TOK-001, or ARN-509
- Participants who have received more than two prior chemotherapy regimens for metastatic CRPC
- Receiving any other investigational anticancer agents
- Known brain metastases
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to tivozanib or enzalutamide
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TivozanibAlso: AV-951Oral | Drug | Experimental Treatment Arm |
| EnzalutamideAlso: MDV-3100oral | Drug | Experimental Treatment Arm |
Primary outcome
Progression Free Survival
Time frame: 2 years
The primary objective of this study will be to demonstrate an improvement in progression free survival in men with metastatic castration resistant prostate cancer (mCRPC) treated with tivozanib and enzalutamide.
4 secondary outcomes
Safety and Tolerability
Time frame: 2 years
Overall Survival
Time frame: 2 years
PSA Response Rate
Time frame: 2 years
Time to PSA Progression
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
M. Dror Michaelson, MD, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tivozanib and Enzalutamide in people with Prostate Cancer, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.