A Study to Evaluate the Potential Increased Risk of Seizures Among Metastatic Castration-Resistant Prostate Cancer (mCRPC) Patients Treated With Enzalutamide
This trial is active, not recruiting.
|Condition||metastatic castration-resistant prostate cancer (mcrpc)|
|Sponsor||Astellas Pharma Global Development, Inc.|
|Start date||September 2013|
|End date||February 2016|
|Trial size||424 participants|
|Trial identifier||NCT01977651, 2013-003022-92, 9785-CL-0403, U1111-1157-0224|
The objective of this study is to evaluate the incidence of seizures and monitor the safety of enzalutamide treatment in subjects with metastatic castration-resistant prostate cancer known to have risk factor(s) for seizure.
|United States||No locations recruiting|
|Other countries||No locations recruiting|
|Anchorage, AK||Site US10005||no longer recruiting|
|Detroit, MI||Site US10024||no longer recruiting|
|Bronx, NY||Montefiore Medical Center-Weiler Hospital||no longer recruiting|
|New York, NY||Site US10014||no longer recruiting|
|Syracuse, NY||Site US10039||no longer recruiting|
|Durham, NC||Site US10016||no longer recruiting|
|Durham, NC||Duke University Medical Center||no longer recruiting|
|Dallas, TX||Site US10008||no longer recruiting|
|Seattle, WA||Fred Hutch / University of Washington Cancer Consortium||no longer recruiting|
|Cordoba, Argentina||Site AR54003||no longer recruiting|
|Santa Fe, Argentina||Site AR54004||no longer recruiting|
|Tucuman, Argentina||Site AR54005||no longer recruiting|
|Berazategui, Argentina||Site AR54001||no longer recruiting|
|Ciudad Autonoma de Buenos Aires, Argentina||Site AR54006||no longer recruiting|
|Kogarah, Australia||Site AU61012||no longer recruiting|
|Macquarie Park, Australia||Site AU61011||no longer recruiting|
|Randwick, Australia||Site AU61005||no longer recruiting|
|Tweed Heads, Australia||Site AU61001||no longer recruiting|
|Nambour, Australia||Site AU61002||no longer recruiting|
|Adelaide, Australia||Site AU61007||no longer recruiting|
|Ballarat, Australia||Site AU61004||no longer recruiting|
|Anderlecht, Belgium||Site BE32004||no longer recruiting|
|Kortrijk, Belgium||Site BE32001||no longer recruiting|
|Liège, Belgium||Site BE32003||no longer recruiting|
|Abbotsford, Canada||Site CA15005||no longer recruiting|
|Halifax, Canada||Site CA15014||no longer recruiting|
|Brampton, Canada||Site CA15004||no longer recruiting|
|Scarborough, Canada||Site CA15010||no longer recruiting|
|Quebec City, Canada||Site CA15001||no longer recruiting|
|Santiago, Chile||Site CL56004||no longer recruiting|
|Temuco, Chile||Site CL56002||no longer recruiting|
|Viña del Mar, Chile||Site CL56003||no longer recruiting|
|Temuco, Chile||Site CL56001||no longer recruiting|
|Praha 2, Czech Republic||Site CZ42004||no longer recruiting|
|Praha 6, Czech Republic||Site CZ42002||no longer recruiting|
|Helsinki, Finland||Site FI35803||no longer recruiting|
|Oulu, Finland||Site FI35801||no longer recruiting|
|Tampere, Finland||Site FI35802||no longer recruiting|
|Lyon Cedex 03, France||Site FR33002||no longer recruiting|
|Rouen Cedex, France||Site FR33004||no longer recruiting|
|Berlin, Germany||Site DE49003||no longer recruiting|
|Münster, Germany||Site DE49001||no longer recruiting|
|Nürtingen, Germany||Site DE49009||no longer recruiting|
|Sopron, Hungary||Site HU36002||no longer recruiting|
|Beer Yakov, Israel||Site IL97201||no longer recruiting|
|Beer-Sheva, Israel||Site IL97203||no longer recruiting|
|Haifa, Israel||Site IL97205||no longer recruiting|
|Jerusalem, Israel||Site IL97204||no longer recruiting|
|Kfar-Saba, Israel||Site IL97202||no longer recruiting|
|Nahariya, Israel||Site IL97208||no longer recruiting|
|Petah Tikva, Israel||Site IL97206||no longer recruiting|
|Ramat Gan, Israel||Site IL97207||no longer recruiting|
|Arezzo, Italy||Site IT39002||no longer recruiting|
|Cremona, Italy||Site IT39001||no longer recruiting|
|Roma, Italy||Site IT39003||no longer recruiting|
|Meldola, Italy||Site IT39005||no longer recruiting|
|Seoul, Korea, Republic of||Site KR82007||no longer recruiting|
|Seoul, Korea, Republic of||Site KR82003||no longer recruiting|
|Seoul, Korea, Republic of||Site KR82001||no longer recruiting|
|Seoul, Korea, Republic of||Site KR82004||no longer recruiting|
|Seongnam-Si, Korea, Republic of||Site KR82006||no longer recruiting|
|Hamilton, New Zealand||Site NZ64001||no longer recruiting|
|Singapore, Singapore||Site SG65002||no longer recruiting|
|Barcelona, Spain||Site ES34003||no longer recruiting|
|Barcelona, Spain||Site ES34004||no longer recruiting|
|Madrid, Spain||Site ES34006||no longer recruiting|
|L'Hospitalet de Llobregat, Spain||Site ES34007||no longer recruiting|
|Sabadell, Spain||Site ES34005||no longer recruiting|
|Pamplona, Spain||Site ES34001||no longer recruiting|
|Göteborg, Sweden||Site SE46001||no longer recruiting|
|Örebro, Sweden||Site SE46002||no longer recruiting|
|Kaoshiung, Taiwan||Site TW88601||no longer recruiting|
|Taipei, Taiwan||Site TW88603||no longer recruiting|
|Sutton, United Kingdom||Site GB44002||no longer recruiting|
|Endpoint classification||safety study|
|Intervention model||single group assignment|
Subjects will receive one daily dosing of enzalutamide
The proportion of evaluable subjects with at least one confirmed seizure as adjudicated by the Independent Adjudication Committee (IAC)
time frame: 4 months
Male participants of any age.
- Subject has histologically confirmed metastatic adenocarcinoma of the prostate.
- Subject has ongoing androgen deprivation therapy with a Gonadotropin-releasing hormone (GnRH) analogue (agonist or antagonist) or bilateral orchiectomy (i.e., surgical or medical castration).
- Subject has disease progression by at least one of the following:
- Prostate-Specific Antigen (PSA) progression defined by a minimum of 2 rising PSA levels with an interval of at least 1 week between each draw;
- Bone disease progression as defined by Prostate Cancer Working Group 2 guidelines (at least 2 new lesions) on bone scan; or
- Soft tissue disease progression as defined by RECIST 1.1
- For subjects who have not had an orchiectomy, there must be a plan to maintain effective GnRH-analogue therapy for the duration of the study.
- Subject must have failed at least one course of androgen deprivation therapy (ADT), i.e., treatment with GnRH analogues.
- Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Subject has been evaluated by a local neurologist prior to study entry who has determined the subject has at least one risk factor for seizure including:
- past history of seizure due to any cause except a single febrile seizure in childhood. Patients with a history of seizures should not have had a seizure within 12 months of Screening and must have had no anticonvulsants for 12 months prior to Screening,
- history of cerebrovascular accident (CVA) or transient ischemic attack (TIA),
- history of traumatic brain or head injury with loss of consciousness
- unexplained loss of consciousness within the last 12 months,
- presence of a space occupying lesion in the brain including previously treated brain metastasis(es) or primary central nervous system (CNS) tumor,
- history of arteriovenous malformations of the brain,
- history of brain infection (i.e., abscess, meningitis, or encephalitis),
- current use of medication that may lower seizure threshold
- presence of Alzheimer's disease, meningioma, leptomeningeal disease from prostate cancer.
- Subject is able to swallow the study drug and comply with study requirements.
- Subject agrees not to participate in another interventional study while on treatment.
- Male subject and his female partner who is of childbearing potential must use two acceptable methods of birth control (one of which must include a condom as a barrier method of contraception) starting at Screening and continuing throughout the study period and for 3 months after final study drug administration.
- Two acceptable forms of birth control include:
- Condom (barrier method of contraception), AND
- One of the following acceptable forms of contraception is required:
- Established use of oral, injected or implanted hormonal methods of contraception.
- Placement of an intrauterine device (IUD) or intrauterine system (IUS).
- Barrier methods of contraception: Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository).
- Vasectomy or surgical castration at least 6 months prior to Screening.
- Male subject must use a condom, if having sex with a pregnant woman.
- Male subject must not donate sperm starting at Screening and throughout the study period and for at least 3 months after final drug administration.
- Subject with a history of exposure to enzalutamide.
- Subject has severe concurrent disease, infection, or co-morbidity that, in the judgment of the Investigator, would make the subject inappropriate for enrollment.
- Subject is currently being treated with anti-epileptics.
- Subject has a history of seizure within the past 12 months of Screening as assessed by neurology examination and history.
- Subject with rapidly progressing visceral disease who has not received and is thought to be able to tolerate cytotoxic chemotherapy. (However, subject who has previously received cytotoxic chemotherapy is permitted).
- Subject has clinical signs suggestive of high or imminent risks for pathological fracture, spinal cord compression and/or cauda equina syndrome.
- Subject's absolute neutrophil count is < 1500/microliter (µL), platelet count is < 100,000/µL) or hemoglobin is < 5.6 millimoles(mmol)/liter (L) (9 grams (g)/deciliter (dL) at Screening.
- Subject's total bilirubin is ≥ 1.5 x upper limit of normal (ULN) (except for subjects with documented Gilbert's disease) or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) is ≥ 2.5x upper limit of normal (ULN) at Screening.
- Subject's estimated creatinine clearance (Cer) is less than 30 milliliter (mL)/minute (min) by the Cockcroft and Gault formula (Creatinine Clearance (mL/min) = (140 - age)(weight (wt) kilogram (kg) / 72 x serum creatinine (milligram (mg)/100 mL) [Cockcroft, 1976] at Screening.
- Subject has uncontrolled hypertension as indicated by a resting systolic blood pressure > 160 millimeter of mercury (mmHg) or diastolic blood pressure > 100 millimeter of mercury (mmHg) at Screening.
- Subject has received an investigational agent within 4 weeks or 5 half lives whichever is longer prior to Day 1.
- Subject has shown a hypersensitivity reaction to the active pharmaceutical ingredient or any of the capsule components, including Labrasol, butylated hydroxyanisole, and butylated hydroxytoluene.
|Official title||A Multicenter, Single-Arm, Open-Label, Post-Marketing Safety Study to Evaluate the Risk of Seizure Among Subjects With Metastatic Castration-Resistant Prostate Cancer (mCRPC) Treated With Enzalutamide Who Are at Potential Increased Risk of Seizure|
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