Clear Cell Renal Cell CarcinomaEarly Phase 1NCT02885649
Enzalutamide Before Surgery in Treating Patients With Kidney Cancer
A Early Phase 1 study testing Enzalutamide, Laboratory Biomarker Analysis and Nephrectomy in people with Clear Cell Renal Cell Carcinoma and Stage I Renal Cell Cancer, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
This pilot phase 0 trial studies how well enzalutamide works before surgery in treating patients with kidney cancer. Androgens are a type of hormone produced by the body that may cause kidney tumors to grow. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clear Cell Renal Cell Carcinoma, Stage I Renal Cell Cancer
- What is being tested?
- Enzalutamide, Laboratory Biomarker Analysis and Nephrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2017to 2 Mar 2020
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical T1N0M0 (=< 7 cm) renal mass as measured on cross-sectional imaging (computed tomography [CT] or magnetic resonance imaging [MRI])
- Biopsy proven ccRCC
- Tumor with androgen receptor (AR) expressed >= 4580 copies/ug ribonucleic acid (RNA)
- Can provide informed consent
- Adequate hepatic function (>= 1.5 x upper limit of normal [ULN]; patient's with Gilbert's disease are not excluded)
- Adequate renal function (estimated glomerular filtration rate [GFR] > 40mL/min)
- No evidence of metastatic disease on baseline imaging (chest x-ray [CXR] or chest CT, abdominal CT or MRI)
- Eastern Cooperative Oncology Group (ECOG) performance status =< 2
Who cannot join
- Prior use of androgen deprivation including enzalutamide
- Pregnant women or women who are of child bearing age who are not willing to use two (2) forms of contraception during treatment with enzalutamide and for six (6) months after treatment
- Men must use adequate methods of contraception during and at least 3 months after treatment if engaging in sexual activity with a female of child bearing age
- Known hypersensitivity to enzalutamide
- History of unprovoked deep vein thrombosis/pulmonary embolism (DVT/PE) in past twelve (12) months
- Inability to stop anticoagulants/antiplatelet therapy peri-operatively
Show all 13Show fewer
- History of seizure or any condition that may predispose to seizure (e.g., prior cortical stroke or significant brain trauma)
- History of loss of consciousness or transient ischemic attack within twelve (12) months of enrollment
- Any unstable, serious co-existing medical conditions including but not limited to myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias, clinically evident congestive heart failure, or cerebrovascular accident within twelve (12) months prior to screening
- Known or suspected brain metastasis or active leptomeningeal disease
- Current use of exogenous testosterone
- Retroperitoneal/hilar adenopathy concerning for locally advanced disease
- Metastatic RCC
Trial locations and contacts
1 site in 1 country.
United States1 site
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
About this study
Official title: Pilot Study of the Blockade of Androgens in Renal Cell Carcinoma Using Enzalutamide (BARE)
This pilot phase 0 trial studies how well enzalutamide works before surgery in treating patients with kidney cancer. Androgens are a type of hormone produced by the body that may cause kidney tumors to grow. Anti-hormone therapy, such as enzalutamide, may lessen the amount of androgens produced by the body and keep kidney tumors from growing.
Read the detailed description
PRIMARY OBJECTIVES:
- To investigate the effects of neoadjuvant enzalutamide on clear cell renal cell carcinoma (ccRCC).
OUTLINE:
Patients receive enzalutamide orally (PO) daily for 90 days in the absence of disease progression or unacceptable toxicity. Patients then undergo partial or radical nephrectomy.
After completion of study treatment, patients are followed up every 3 months.
- Being tested
- Enzalutamide, Laboratory Biomarker Analysis, Nephrectomy
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EnzalutamideDrug
Also called ASP9785, MDV3100, Xtandi
Given PO
Laboratory Biomarker AnalysisOther
Correlative studies
NephrectomyProcedure or surgery
Undergo partial or radical nephrectomy
| Study group | Role | What they receive |
|---|---|---|
| Treatment (enzalutamide, nephrectomy) | Experimental | Patients receive enzalutamide PO daily for 90 days in the absence of disease progression or unacceptable toxicity. Patients then undergo partial or radical nephrectomy. Receives: Drug: Enzalutamide; Other: Laboratory Biomarker Analysis; Procedure: Nephrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cell proliferation
Measured: Up to 36 months
Tumor apoptosis as measured by annexin
Measured: Up to 36 months
Secondary outcomes (2)
Incidence of adverse events (AEs) as assessed by Common Terminology Criteria for Adverse Events version 4
Post-operative complications will be documented according to the Clavien-Dindo Classification System.
Measured: Up to 36 months
Tumor size as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2016 (estimated)
- Study start5 Dec 2017
- Primary completion2 Mar 2020
- Study completion2 Mar 2020
Why it stopped: Funding unavailable
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clear Cell Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Eric A. Singer, MD, MA, MS, FACS, Rutgers Cancer Institute of New Jersey
- Investigators
- Eric Singer, Principal investigator, Rutgers Cancer Institute of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02885649
- Sponsor's protocol ID
- Pro20170000806
- Other IDs
- NCI-2016-01113, 081604, P30CA072720
- Status last verified
- Sep 2021
- First submitted
- 26 Aug 2016
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of the Blockade of Androgens in Renal Cell Carcinoma Using Enzalutamide (BARE)
- ClinicalTrials.gov ID
- NCT02885649
- Acronym / sponsor ID
- Pro20170000806
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding unavailable
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 5 Dec 2017 (actual)
- Primary completion
- 2 Mar 2020 (actual)
- Study completion
- 2 Mar 2020 (actual)
- First posted
- 31 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot phase 0 trial studies how well enzalutamide works before surgery in treating patients with kidney cancer. Androgens are a type of hormone produced by the body that may cause kidney tumors to grow. Anti-hormone therapy, such as enzalutamide, may lessen the amount of androgens produced by the body and keep kidney tumors from growing.
Detailed description
PRIMARY OBJECTIVES:
- To investigate the effects of neoadjuvant enzalutamide on clear cell renal cell carcinoma (ccRCC).
OUTLINE:
Patients receive enzalutamide orally (PO) daily for 90 days in the absence of disease progression or unacceptable toxicity. Patients then undergo partial or radical nephrectomy.
After completion of study treatment, patients are followed up every 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (enzalutamide, nephrectomy) | Experimental | Drug: Enzalutamide, Other: Laboratory Biomarker Analysis, Procedure: NephrectomyPatients receive enzalutamide PO daily for 90 days in the absence of disease progression or unacceptable toxicity. Patients then undergo partial or radical nephrectomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Clinical T1N0M0 (=< 7 cm) renal mass as measured on cross-sectional imaging (computed tomography [CT] or magnetic resonance imaging [MRI])
- Biopsy proven ccRCC
- Tumor with androgen receptor (AR) expressed >= 4580 copies/ug ribonucleic acid (RNA)
- Can provide informed consent
- Adequate hepatic function (>= 1.5 x upper limit of normal [ULN]; patient's with Gilbert's disease are not excluded)
Key exclusion criteria (13 listed)
- Prior use of androgen deprivation including enzalutamide
- Pregnant women or women who are of child bearing age who are not willing to use two (2) forms of contraception during treatment with enzalutamide and for six (6) months after treatment
- Men must use adequate methods of contraception during and at least 3 months after treatment if engaging in sexual activity with a female of child bearing age
- Known hypersensitivity to enzalutamide
- History of unprovoked deep vein thrombosis/pulmonary embolism (DVT/PE) in past twelve (12) months
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 |
|---|---|---|
| EnzalutamideAlso: ASP9785, MDV3100, XtandiGiven PO | Drug | Treatment (enzalutamide, nephrectomy) |
| Laboratory Biomarker AnalysisCorrelative studies | Other | Treatment (enzalutamide, nephrectomy) |
| NephrectomyUndergo partial or radical nephrectomy | Procedure or surgery | Treatment (enzalutamide, nephrectomy) |
Primary outcome
Cell proliferation
Time frame: Up to 36 months
Tumor apoptosis as measured by annexin
Time frame: Up to 36 months
2 secondary outcomes
Incidence of adverse events (AEs) as assessed by Common Terminology Criteria for Adverse Events version 4
Time frame: Up to 36 months
Tumor size as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Time frame: Up to 36 months
Results and safety
The study was stopped early (reason given: Funding unavailable). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
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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.
Eric Singer principal investigator
Rutgers Cancer Institute of New Jersey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Enzalutamide, Laboratory Biomarker Analysis and Nephrectomy in people with Clear Cell Renal Cell Carcinoma and Stage I Renal Cell Cancer, run by Rutgers, The State University of New Jersey 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 8 inclusion and 13 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 16 Sep 2021. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Funding unavailable). Results are not available in the source record.
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?
Cell proliferation (time frame: Up to 36 months). The study lists 2 primary outcomes in all. 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 16 Sep 2021.