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An Open Label, Single Arm, Extension Study to Evaluate the Long Term Safety of Denosumab for Prolonging Bone Metastasis-Free Survival in Men With Hormone-Refractory Prostate Cancer


Phase 3
18 Years
N/A
Open (Enrolling)
Male
Castrate-resistant Prostate Cancer

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Trial Information

An Open Label, Single Arm, Extension Study to Evaluate the Long Term Safety of Denosumab for Prolonging Bone Metastasis-Free Survival in Men With Hormone-Refractory Prostate Cancer


Inclusion Criteria:



- Subjects currently undergoing every 4 weeks scheduled assessments in the phase 3
study 20050147

- Subjects must sign the informed consent before any study specific procedures are
performed

Exclusion Criteria:

- Developed sensitivity to mammalian cell derived drug products during the 20050147
study

- Currently receiving any unapproved investigational product other than denosumab

- Any disorder that, in the opinion of the investigator, may compromise the ability of
the subject to give written informed consent and/or comply with study procedures

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence of treatment-emergent adverse events

Outcome Time Frame:

4 weeks after the last dose of open label treatment

Safety Issue:

Yes

Principal Investigator

MD

Investigator Role:

Study Director

Investigator Affiliation:

Amgen

Authority:

United States: Food and Drug Administration

Study ID:

20080585

NCT ID:

NCT01824342

Start Date:

January 2011

Completion Date:

May 2014

Related Keywords:

  • Castrate-Resistant Prostate Cancer
  • Neoplasm Metastasis
  • Prostatic Neoplasms

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