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Trial record 5 of 56 for:    mdv3100 | Open Studies

A Study to Monitor the Safety of Enzalutamide in Patients With Progressive Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2014 by Astellas Pharma Inc
Medivation, Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Europe B.V. ) Identifier:
First received: April 25, 2014
Last updated: June 4, 2014
Last verified: June 2014

The purpose of this study is to monitor the safety of enzalutamide in patients with progressive castration-resistant prostate cancer previously treated with docetaxel-based chemotherapy.

Condition Intervention Phase
Prostate Cancer
Castration-Resistant Prostate Cancer
Drug: Enzalutamide
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2, Multicenter, Single-arm, Open Label Study to Monitor the Safety of Enzalutamide in Patients With Progressive Castration-Resistant Prostate Cancer Previously Treated With Docetaxel-Based Chemotherapy

Resource links provided by NLM:

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Safety profile of enzalutamide assessed by adverse events (AEs), serious AEs (SAEs), vital signs, electrocardiograms (ECGs) and laboratory measurements [ Time Frame: Up to 30 days after the last dose of enzalutamide or prior to the initiation of another anticancer therapy, whichever comes first (up to 18 months) ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: September 2014
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Enzalutamide Drug: Enzalutamide
Other Names:
  • Xtandi
  • MDV3100


Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subject has histologically or cytologically confirmed adenocarcinoma of the prostate
  • Subject has ongoing androgen deprivation therapy with a gonadotropin-releasing hormone (GnRH) analogue (agonist or antagonist) and plans to maintain throughout the study period or has had a prior orchiectomy (i.e., surgical or medical castration)
  • Subject has had at least one prior chemotherapy regimen for metastatic castration-resistant prostate cancer with at least one regimen containing docetaxel
  • Subject has progressive disease and indication for change of antineoplastic regimen
  • Subject has no known or suspected brain metastasis
  • Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Subject is able to swallow the study drug and comply with study requirements
  • There is no comparable or satisfactory alternative therapy to treat the subject's disease
  • Subject agrees not to participate in another interventional study while on treatment

Exclusion Criteria:

  • Subject has severe concurrent disease, infection, or co-morbidity that would make the subject inappropriate for enrollment
  • Subject's absolute neutrophil count is < 1000/μL, or platelet count < 100,000/μL, or hemoglobin < 6.2 mmol/L (or < 10 g/dL)
  • 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 ULN
  • Subject's estimated creatinine clearance is less than 30 mL/min by the Cockcroft and Gault formula
  • Subject has albumin ≤ 30 g/L (or ≤ 3.0 g/dL)
  • Subject has received anti-androgen therapy (e.g. bicalutamide), chemotherapy, or biologic therapy for prostate cancer (other than bone targeted agents such as bisphosphonates or denosumab, gonadotropin-releasing hormone (GnRH) analogue therapy, or glucocorticoids which are allowed) within 4 weeks of Day 1
  • Subject has had prior use of abiraterone
  • Subject has prior use, or participation in a clinical trial, of an investigational agent that blocks androgen synthesis (e.g. TAK-700) or targets the androgen receptor (e.g. ARN-509, ODM-201)
  • Subject has:

    1. A history of seizure, including any febrile seizure or any condition that may predispose to seizure including, but not limited to underlying brain injury, stroke, primary brain tumors, brain metastases,
    2. A history of loss of consciousness or transient ischemic attack within 12 months of Screening
  • Subject has clinical signs suggestive of high or imminent risks for pathological fracture, spinal cord compression and/or cauda equina syndrome
  • Subject has a significant cardiovascular disease
  • Subject has received investigational therapy within 28 days or 5 half lives, whichever is longer, prior to Screening
  • Subject has undergone major surgery within 4 weeks prior to Screening
  • Subject has shown a hypersensitivity reaction to the active pharmaceutical ingredient or any of the capsule components, including Labrasol, butylated hydroxyanisole, and butylated hydroxytoluene
  • Subject has used or plans to use, from 30 days prior to enrollment through the end of the study, medications known to lower the seizure threshold or prolong the QT interval
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02124668

Contact: Global Clinical Science +31 (0)71 5455 500

Sponsors and Collaborators
Astellas Pharma Europe B.V.
Medivation, Inc.
Study Director: Medical Director Astellas Pharma Europe B.V.
  More Information

No publications provided

Responsible Party: Astellas Pharma Inc ( Astellas Pharma Europe B.V. ) Identifier: NCT02124668     History of Changes
Other Study ID Numbers: 9785-CL-0122
Study First Received: April 25, 2014
Last Updated: June 4, 2014
Health Authority: Russia: Ethics Committee
Moldova: Medicines Agency

Keywords provided by Astellas Pharma Inc:
Progressive Castration-Resistant Prostate Cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms processed this record on November 24, 2014