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NCT01934790 · ClinicalTrials.gov registry record · Phase 1
Re-treatment Safety of Radium-223 Dichloride in Castration-resistant Prostate Cancer With Bone Metastases
A Phase 1 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 1
- Development phase
- 45
- Enrollment target
NCT01934790 is a Phase 1 study that has completed, run by Bayer. The registered enrollment target is 45 participants.
The verdict
NCT01934790, a Phase 1 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 45 participants
- Enrollment target
Study Summary
Eligible subjects must have completed 6 doses of treatment of radium-223 dichloride and experienced no radium-223 dichloride-related SAEs (serious adverse events) or CTCAE (Common Terminology Criteria for Adverse Events) Grade 3 or 4 adverse event during or after the initial course of radium-223 dichloride that led to the discontinuation of treatment. 40 Subjects will be enrolled and will receive up to 6 doses of radium-223 dichloride 50 kBq/kg IV every 4 weeks. The subject will be evaluated for AEs (adverse events) and laboratory tests at each visit every 4 weeks, prior to receiving radium-223 dichloride. After the end of treatment visit the subjects will enter the active follow up period. Related AEs and SAEs and Lab tests will be evaluated at each visit every 4 weeks for the first 12 weeks, then every 12 weeks for up to 2 years after the last dose of radium-223 dichloride. After the 2 years of active follow-up, subjects will enter the long-term follow-up period and will be followed via telephone follow-up at 6-month intervals for late toxicities and survival up to 7 years after the last dose of radium-223 dichloride or until death. Joint safety reviews will regularly take place to oversee safety of the subjects conducted at regular intervals. An interim analysis of the safety data will be conducted during the study.
Interventions
- DRUG Radium-223 dichloride (Xofigo, BAY88-8223)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2013-12-22 |
| Est. Completion | 2017-04-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01934790
The ClinicalTrials.gov registry entry for NCT01934790 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 45 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bayer, which has 591 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Radium-223 dichloride (Xofigo, BAY88-8223) is the first listed.
NCT01934790 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01934790 about?
NCT01934790 is a clinical study titled "Re-treatment Safety of Radium-223 Dichloride in Castration-resistant Prostate Cancer With Bone Metastases". Eligible subjects must have completed 6 doses of treatment of radium-223 dichloride and experienced no radium-223 dichloride-related SAEs (serious adverse events) or CTCAE (Common Terminology Criteria for Adverse Events) Grade 3 or 4 adverse event during or after the initial course of radium-223 dic...
What is the current status of trial NCT01934790?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 45 participants. The study started on 2013-12-22. Estimated completion is 2017-04-12.
What interventions are being tested in trial NCT01934790?
The interventions under investigation include: Radium-223 dichloride (Xofigo, BAY88-8223) (DRUG).
Who is sponsoring clinical trial NCT01934790?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
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