Clinical trial · Interventional
Enzalutamide Before Surgery in Treating Patients With Kidney Cancer
Pilot Study of the Blockade of Androgens in Renal Cell Carcinoma Using Enzalutamide (BARE)
NCT02885649CI-TRIAL-00053889terminatedEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Funding unavailable
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Clear Cell Renal Cell Carcinoma | Clear Cell Renal Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Stage I Renal Cell Cancer | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Enzalutamide | Drug | Enzalutamide | ALIAS |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
| Nephrectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (enzalutamide, nephrectomy)
- description
- Patients receive enzalutamide PO daily for 90 days in the absence of disease progression or unacceptable toxicity. Patients then undergo partial or radical nephrectomy.
- interventionNames
- Drug: Enzalutamide
- Other: Laboratory Biomarker Analysis
- Procedure: Nephrectomy
Primary outcomes (2)
- measure
- Cell proliferation
- timeFrame
- Up to 36 months
- measure
- Tumor apoptosis as measured by annexin
- timeFrame
- Up to 36 months
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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 * 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
References
Publications (0)
Data not yet available
No reference posted for this study.