Trials / Completed
CompletedNCT01618370
Radium(223) Dichloride (Alpharadin) in Castration-Resistant (Hormone-Refractory) Prostate Cancer Patients With Bone Metastases
Radium-223 Dichloride (Alpharadin) in Castration-Resistant (Hormone-Refractory) Prostate Cancer Patients With Bone Metastases
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 705 (actual)
- Sponsor
- Bayer · Industry
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This study is a prospective, interventional, open-label, multi-center early access program for the use of Ra-223 Cl2 in HRPC/CRPC (Hormone refractory prostate cancer / Castrate resistant prostate cancer) patients diagnosed with bone metastasis and to collect additional short and long term safety data on the product.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Radium-223 dichloride (BAY88-8223) | One injection to be administered every 4 weeks up to 6 injections. The dose per injection is 50 kBq/kg body weight. |
Timeline
- Start date
- 2012-07-22
- Primary completion
- 2014-08-13
- Completion
- 2016-02-28
- First posted
- 2012-06-13
- Last updated
- 2017-03-31
Locations
215 sites across 19 countries: Belgium, Canada, Czechia, Denmark, Finland, France, Germany, Ireland, Israel, Italy, Mexico, Netherlands, Norway, Poland, Russia, Spain, Sweden, Switzerland, United Kingdom
Source: ClinicalTrials.gov record NCT01618370. Inclusion in this directory is not an endorsement.