CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 36 enrolled
Drug / intervention
Concurrent use of Radium Ra 223 dichloride and Abiraterone Acetate plus Prednisonedrug
Likely dose
Not stated in 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/NCT02097303
NCT02097303Phase 2Completed
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Open Label Phase Two Trial of Radium Ra 223 Dichloride With Concurrent Administration of Abiraterone Acetate Plus Prednisone in Symptomatic Castration-Resistant (Hormone-Refractory) Prostate Cancer Subjects With Bone Metastasis

Carolina Research Professionals, LLC·interventional·Posted Mar 27, 2014·Updated Feb 1, 2018

In Brief

A Phase 2 clinical trial evaluating Concurrent use of Radium Ra 223 dichloride and Abiraterone Acetate plus Prednisone for Prostate Cancer. Completed, enrolled 36 participants across 5 sites.

Detailed Summary

This is an open label study designed to examine the effects on concurrent administration of Radium Ra 223 dichloride and Abiraterone Acetate plus Prednisone in subjects with symptomatic castrate resistant prostate cancer and with bone metastases, in both the pre- and post- chemotherapy setting. Both medications are approved by the US Food and Drug Administration for this indication.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesUnited States
CollaboratorsBayer

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMar 27, 2014
Enrollment StartMar 1, 2014
Primary CompletionDec 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 12.3 years ago

Interventions

Concurrent use of Radium Ra 223 dichloride and Abiraterone Acetate plus Prednisonedrug

Radium Ra 223 dichloride - A targeted alpha particle-emitting pharmaceutical (a radiopharmaceutical drug) is a ready-to-use solution for intravenous injection containing the drug substance radium dichloride. The active moiety is the alpha particle emitting nuclide Ra-223, present as a divalent cation (223Ra2+) and Abiraterone Acetate - A CYP17 inhibitor, indicated in combination with prednisone for the treatment of subjects with metastatic castration-resistant prostate cancer. Administration of Abiraterone Acetate may result in mineralocorticoid-related adverse events (AEs), due to CYP17 inhibition. Therefore, Abiraterone Acetate is administered in combination with Prednisone to reduce the frequency of these AEs.