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Trial record 3 of 182 for:    Enzalutamide

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 ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Medivation, Inc.
Information provided by (Responsible Party):
Astellas Pharma Inc ( Astellas Pharma Europe B.V. )
ClinicalTrials.gov Identifier:
NCT02124668
First received: April 25, 2014
Last updated: May 4, 2017
Last verified: May 2017
  Purpose
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
Castration-Resistant Prostate Cancer Prostate Cancer Drug: Enzalutamide Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
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 ( Astellas Pharma Europe B.V. ):

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) ]

Estimated Enrollment: 30
Actual Study Start Date: September 30, 2014
Estimated Study Completion Date: July 3, 2017
Estimated Primary Completion Date: July 3, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Enzalutamide
Enzalutamide
Drug: Enzalutamide
oral
Other Names:
  • Xtandi
  • MDV3100

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT02124668

Locations
Georgia
Site GE99503 National Insitute of Urology
Tbilisi, Georgia, 144
Site GE99502 New Vision University Hospital L.T.D.
Tbilisi, Georgia
Russian Federation
Site RU70002 Blokhin Oncology Centre
Moscow, Russian Federation, 115478
Site RU70003 Hertsen's Institute
Moscow, Russian Federation, 125284
Sponsors and Collaborators
Astellas Pharma Europe B.V.
Medivation, Inc.
Investigators
Study Director: Medical Director Astellas Pharma Europe B.V.
  More Information

Responsible Party: Astellas Pharma Europe B.V.
ClinicalTrials.gov Identifier: NCT02124668     History of Changes
Other Study ID Numbers: 9785-CL-0122
Study First Received: April 25, 2014
Last Updated: May 4, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Astellas Pharma Inc ( Astellas Pharma Europe B.V. ):
Xtandi
MDV3100
Progressive Castration-Resistant Prostate Cancer
Enzalutamide

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 21, 2017