A Study to Evaluate the Potential Increased Risk of Seizures Among Metastatic Castration-Resistant Prostate Cancer (mCRPC) Patients Treated With Enzalutamide

NCT01977651

Last updated date
Study Location
Site US10005
Anchorage, Alaska, 99503, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Metastatic Castration-resistant Prostate Cancer (mCRPC)
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0 +
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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:

1. 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;

2. Bone disease progression as defined by Prostate Cancer Working Group 2 guidelines (at least 2 new lesions) on bone scan; or

3. 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:

1. 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,

2. history of cerebrovascular accident (CVA) or transient ischemic attack (TIA),

3. history of traumatic brain or head injury with loss of consciousness

4. unexplained loss of consciousness within the last 12 months,

5. presence of a space occupying lesion in the brain including previously treated brain metastasis(es) or primary central nervous system (CNS) tumor,

6. history of arteriovenous malformations of the brain,

7. history of brain infection (i.e., abscess, meningitis, or encephalitis),

8. current use of medication that may lower seizure threshold

9. 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.

1. Two acceptable forms of birth control include:

1. Condom (barrier method of contraception), AND

2. One of the following acceptable forms of contraception is required:

1. Established use of oral, injected or implanted hormonal methods of contraception.

2. Placement of an intrauterine device (IUD) or intrauterine system (IUS).

3. Barrier methods of contraception: Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository).

4. 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.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Metastatic Castration-resistant Prostate Cancer (mCRPC)A Study to Evaluate the Potential Increased Risk of Seizures Among Metastatic Castration-Resistant Prostate Cancer (mCRPC) Patients Treated With Enzalutamide
NCT01977651
  1. Anchorage, Alaska
  2. Detroit, Michigan
  3. Bronx, New York
  4. New York, New York
  5. New York, New York
  6. Syracuse, New York
  7. Durham, North Carolina
  8. Dallas, Texas
  9. Seattle, Washington
  10. Berazategui, Buenos Aires
  11. Ciudad Autonoma de BuenosAires, Buenos Aires
  12. Buenos Aires, Caba
  13. Cordoba,
  14. Santa Fe,
  15. Tucuman,
  16. Kogarah, New South Wales
  17. Randwick, New South Wales
  18. Sydney, New South Wales
  19. Tweed Heads, New South Wales
  20. Nambour, Queensland
  21. Adelaide, South Australia
  22. Ballarat, Victoria
  23. Anderlecht,
  24. Kortrijk,
  25. Liege,
  26. Abbotsford, British Columbia
  27. Halifax, Nova Scotia
  28. Brampton, Ontario
  29. Scarborough, Ontario
  30. Quebec City, Quebec
  31. Temuco, IX Region
  32. Santiago,
  33. Temuco,
  34. Vina del Mar,
  35. Praha 2,
  36. Praha 6,
  37. Helsinki,
  38. Oulu,
  39. Tampere,
  40. Lyon Cedex 03,
  41. Rouen Cedex,
  42. Suresnes,
  43. Nürtingen, Baden-Württemberg
  44. Berlin,
  45. Munster,
  46. Sopron, Gyor-Moson Sopron
  47. Kfar Saba, HaMerkaz
  48. Be'er Ya'akov,
  49. Beer-Sheva,
  50. Haifa,
  51. Jerusalem,
  52. Nahariya,
  53. Petah-Tiqva,
  54. Ramat Gan,
  55. Meldola, Emilia-Romagna
  56. Cremona, Lombardia
  57. Arezzo,
  58. Roma,
  59. Seongnam-Si, Gyeonggi-do
  60. Seoul,
  61. Seoul,
  62. Seoul,
  63. Seoul,
  64. Hamilton,
  65. Singapore,
  66. Hospitalet de Llobregat, Barcelona
  67. Sabadell, Barcelona
  68. Pamplona, Navarra
  69. Barcelona,
  70. Barcelona,
  71. Madrid,
  72. Goteborg,
  73. Orebro,
  74. Kaohsiung,
  75. Taipei City,
  76. Sutton, Surrey
Male
0+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Potential Increased Risk of Seizures Among Metastatic Castration-Resistant Prostate Cancer (mCRPC) Patients Treated With Enzalutamide
Official Title  ICMJE A Multicenter, Single-arm, Open-label, Postmarketing 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
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Castration-resistant Prostate Cancer (mCRPC)
Intervention  ICMJE Drug: enzalutamide
Participants will receive 4 capsules (40 mg each) of enzalutamide orally once a day, for a total daily dose of 160 mg. Treatment will be given with or without food and as close as possible to the same time each day.
Other Names:
  • Xtandi
  • MDV3100
Study Arms  ICMJE Experimental: Enzalutamide 160 mg
Participants will receive 160 mg of enzalutamide orally once a day, for 4 months.
Intervention: Drug: enzalutamide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 18, 2015)
424
Original Estimated Enrollment  ICMJE
 (submitted: October 31, 2013)
400
Actual Study Completion Date  ICMJE January 11, 2019
Actual Primary Completion Date February 1, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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:

    1. 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;
    2. Bone disease progression as defined by Prostate Cancer Working Group 2 guidelines (at least 2 new lesions) on bone scan; or
    3. 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:

    1. 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,
    2. history of cerebrovascular accident (CVA) or transient ischemic attack (TIA),
    3. history of traumatic brain or head injury with loss of consciousness
    4. unexplained loss of consciousness within the last 12 months,
    5. presence of a space occupying lesion in the brain including previously treated brain metastasis(es) or primary central nervous system (CNS) tumor,
    6. history of arteriovenous malformations of the brain,
    7. history of brain infection (i.e., abscess, meningitis, or encephalitis),
    8. current use of medication that may lower seizure threshold
    9. 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.

    1. Two acceptable forms of birth control include:

    1. Condom (barrier method of contraception), AND
    2. One of the following acceptable forms of contraception is required:

      1. Established use of oral, injected or implanted hormonal methods of contraception.
      2. Placement of an intrauterine device (IUD) or intrauterine system (IUS).
      3. Barrier methods of contraception: Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository).
      4. 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.

Exclusion Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Australia,   Belgium,   Canada,   Chile,   Czechia,   Finland,   France,   Germany,   Hungary,   Israel,   Italy,   Korea, Republic of,   New Zealand,   Singapore,   Spain,   Sweden,   Taiwan,   United Kingdom,   United States
Removed Location Countries Czech Republic,   Greece,   Hong Kong
 
Administrative Information
NCT Number  ICMJE NCT01977651
Other Study ID Numbers  ICMJE 9785-CL-0403
2013-003022-92 ( EudraCT Number )
U1111-1157-0224 ( Registry Identifier: World Health Organization (WHO) )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.
Supporting Materials:Study Protocol
Supporting Materials:Statistical Analysis Plan (SAP)
Supporting Materials:Clinical Study Report (CSR)
Time Frame:Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
Access Criteria:Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
URL:https://www.clinicalstudydatarequest.com/
Responsible Party Astellas Pharma Inc ( Astellas Pharma Global Development, Inc. )
Study Sponsor  ICMJE Astellas Pharma Global Development, Inc.
Collaborators  ICMJE Medivation LLC, a wholly owned subsidiary of Pfizer Inc.
Investigators  ICMJE
Study Director:Sr. Medical DirectorAstellas Pharma Global Development, Inc.
PRS Account Astellas Pharma Inc
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP