CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 70 enrolled
Drug / intervention
Radium-223 dichloride (Xofigo, BAY88-8223) +1 moredrug
Likely dose
Docetaxel 75 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01106352
NCT01106352Phase 2Completed
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A Phase I/IIa Study of Safety and Efficacy of Alpharadin® With Docetaxel in Patients With Bone Metastasis From Castration-Resistant Prostate Cancer

Bayer·interventional·Posted Apr 19, 2010·Updated Jan 4, 2017

In Brief

A Phase 2 clinical trial evaluating Radium-223 dichloride (Xofigo, BAY88-8223) and Docetaxel for Bone Metastases and Castration-Resistant Prostate Cancer. Completed, enrolled 70 participants across 7 sites in 2 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBone Metastases, Castration-Resistant Prostate Cancer
CountriesFrance, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 19, 2010
Enrollment StartJul 1, 2010
Primary CompletionJun 1, 2015
TodayJul 2, 2026
Enrollment to primary: 4.9 yearsPosted 16.2 years ago

Interventions

Radium-223 dichloride (Xofigo, BAY88-8223)drug

Alpharadin (Radium-223 dichloride) is administered intravenously as a bolus injection.

Docetaxeldrug

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.