Trials / Completed
CompletedNCT01106352
A Study of Alpharadin With Docetaxel in Patients With Bone Metastasis From Castration-Resistant Prostate Cancer (CRPC)
A Phase I/IIa Study of Safety and Efficacy of Alpharadin® With Docetaxel in Patients With Bone Metastasis From Castration-Resistant Prostate Cancer
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 70 (actual)
- Sponsor
- Bayer · Industry
- Sex
- Male
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The main purpose of this study is to establish a recommended dose of Alpharadin to be used in combination with docetaxel in patients with bone metastases from castration-resistant prostate cancer and to investigate safety and explore efficacy of the recommended dose.
Detailed description
The trial was initially conducted and submitted by Algeta ASA. After acquiring Algeta, Bayer is now the sponsor.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Radium-223 dichloride (Xofigo, BAY88-8223) | Alpharadin (Radium-223 dichloride) is administered intravenously as a bolus injection. |
| DRUG | Docetaxel | Docetaxel (75 mg/m\^2) will be administered intravenously every 3 weeks with 5 mg prednisone twice a day continuously and pre-medication with dexamethasone. Step-down to 60 mg/m\^2 is allowed as per the approved docetaxel label. |
Timeline
- Start date
- 2010-07-01
- Primary completion
- 2015-06-01
- Completion
- 2015-06-01
- First posted
- 2010-04-19
- Last updated
- 2017-01-04
- Results posted
- 2016-11-09
Locations
7 sites across 2 countries: United States, France
Source: ClinicalTrials.gov record NCT01106352. Inclusion in this directory is not an endorsement.