Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
drksid header

  DRKS00006448

Trial Description

start of 1:1-Block title

Title

A Multi-center, Single Arm Study of Enzalutamide in Patients With Progressive Metastatic Castration-Resistant Prostate Cancer Previously Treated With Abiraterone Acetate

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

The objective of this study is to evaluate the efficacy and safety of enzalutamide treatment
in patients with progressive metastatic castration-resistant prostate cancer previously
treated with abiraterone acetate.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

[---]*

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00006448
  •   2015/03/20
  •   2014/04/15
  •   no
  •   [---]*
  •   [---]*
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   2013-002271-17 
  •   NCT02116582  (ClinicalTrials.gov)
  •   9785-CL-0410  (Astellas Pharma Europe B.V.)
  •   2013-002271-17 
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   Metastatic Castration-Resistant Prostate Cancer
  •   C61 -  Malignant neoplasm of prostate
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Drug: Enzalutamide
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   IV
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

- Radiographic progression-free survival (rPFS); time frame: until subject discontinuation (up to 2 years); rPFS is defined as the time interval from first dose to objective evidence of radiographic disease progression or death for any reason, whichever occurs first

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

- Overall Survival (OS); time frame: until subject discontinuation (up to 2 years)
- Prostate-specific antigen (PSA) response; time frame: until subject discontinuation (up to 2 years)
- Time to PSA progression; time frame: until subject discontinuation (up to 2 years)
- Safety assessed through evaluation of Adverse Events and Serious Adverse Events, safety laboratory tests, physical examination and vital signs; time frame: Time from signing informed consent to 30 days after last dose of study drug.

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Belgium
  •   France
  •   Germany
  •   Spain
  •   United Kingdom
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
  •  
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   [---]*
  •   2014/05/31
  •   200
  •   Multicenter trial
  •   International
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Male
  •   18   Years
  •   no maximum age
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

- Subject has histologically confirmed adenocarcinoma of the prostate without
neuro-endocrine differentiation or small cell features.

- Subject has metastatic disease documented by bone scan or by soft tissue disease
observed by Computed Tomography/Magnetic Resonance Imaging (CT/MRI) at screening, or
within ≤30 days prior to Day 1.

- In the setting of castrate levels of testosterone ≤1.7 nmol/L (or ≤50 ng/dL), subject
has progressive disease at study entry defined as PSA rise determined by a minimum of
2 rising PSA levels with an interval of ≥ 1 week between each assessment. The PSA
value at the screening visit should be ≥ 2 ng/mL WITH or WITHOUT:

- Soft tissue disease progression defined by Response Evaluation Criteria In Solid
Tumors (RECIST 1.1) at screening, or within ≤30 days prior to Day 1. Measurable
disease is not required for entry. Lymph nodes ≥ 2 cm are considered measurable
disease (Prostate Cancer Clinical Trials Working Group (PCWG2)).

- Bone disease progression defined by at least 2 new lesions on bone scan at
screening, or within ≤30 days prior to Day 1.

- Subject must have received a minimum of 24 weeks of treatment with abiraterone
acetate within its approved label indication and has discontinued use at least 4
weeks prior to start of study drug at Day 1.

- If the subject has received previous treatment with chemotherapy for prostate cancer,
this must be limited to no more than one prior line of docetaxel, and must have been
used prior to abiraterone acetate therapy.

- Subject receives and will continue to receive ongoing androgen deprivation with
Luteinizing-hormone-releasing hormone (LHRH) analogue therapy throughout the course
of the study or has had a bilateral orchiectomy.

- Subject is asymptomatic or mildly symptomatic from prostate cancer:

- The score on Brief Pain Inventory - Short Form (BPI-SF) Question #3 must be < 4.

- No use of opiate analgesics for prostate cancer-related pain currently or
anytime within 4 weeks prior to screening.

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

- Subject has prior use of ketoconazole for the treatment of prostate cancer.

- Subject has prior use of cabazitaxel.

- Subject has prior use of enzalutamide.

- Subject has received ANY anti-neoplastic therapy (including antiandrogens and
chemotherapy) following abiraterone acetate discontinuation and prior to start of
study drug at Day 1.

- Subject has a known or suspected hypersensitivity to enzalutamide, or any components
of the formulation used.

- Subject has known or suspected brain metastases or active leptomeningeal disease.

- Subject has history of seizure or any condition that may predispose to seizure (e.g.,
prior stroke or significant brain trauma).

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Astellas Pharma Europe B.V.
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address other
    • Medivation, Inc.
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact other
  • start of 1:1-Block address scientific-contact
    • Astellas Pharma BV
    • Medical Monitor 
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Astellas Pharma BV
    • Medical Monitor 
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up continuing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   3
  •   2016/01/14


* This entry means the parameter is not applicable or has not been set.