Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01106352 · ClinicalTrials.gov registry record · Phase 1
A Study of Alpharadin With Docetaxel in Patients With Bone Metastasis From Castration-Resistant Prostate Cancer (CRPC)
A Phase 1 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 1
- Development phase
- 70
- Enrollment target
NCT01106352: Completed Phase 1 study, sponsored by Bayer.
NCT01106352 is a Phase 1 study that has completed, run by Bayer. The registered enrollment target is 70 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01106352, a Phase 1 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 70 participants
- Enrollment target
Study 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.
Primary Outcome
DLT was defined as - Absolute neutrophil count grade greater than or equal to (\>=) 4 (Common Terminology Criteria for Adverse Events \[CTCAE\], Version 4.0: less than \[\<\] 0.5 × 109 per Liter) lasting longer than 7 days without fever despite granulocyte colony-stimulating factor (G-CSF) support). Platelet count Grade \>= 4 (CTCAE, v4.0: \< 25× 109/L) lasting longer than 7 days. Diarrhea Grade \>= 3 (CTAE, v4.0: increase of \>= 7 stools per day over baseline; incontinence; hospitalization indi
Interventions
- DRUG Docetaxel
- DRUG Radium-223 dichloride (Xofigo, BAY88-8223)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2010-07 |
| Est. Completion | 2015-06 |
| Phase | Phase 1 |
What the finished NCT01106352 record still lists
NCT01106352 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% higher).
The record links to 0 conditions, and to 2 interventions - of which Docetaxel is the first listed.
NCT01106352 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01106352 about?
NCT01106352 is a clinical study titled "A Study of Alpharadin With Docetaxel in Patients With Bone Metastasis From Castration-Resistant Prostate Cancer (CRPC)". 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.
What is the current status of trial NCT01106352?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 70 participants. The study started on 2010-07. Estimated completion is 2015-06.
What interventions are being tested in trial NCT01106352?
The interventions under investigation include: Docetaxel (DRUG), Radium-223 dichloride (Xofigo, BAY88-8223) (DRUG).
Who is sponsoring clinical trial NCT01106352?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01106352's enrollment target sits among peer trials
70 749th of 2000 higher than 1,227 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT00969111 · 70 participants · NA
Postoperative or Salvage Radiotherapy (RT) for Node Negative Prostate Cancer Following Radical Prostatectomy
- NCT01712620 · 70 participants · Phase 2
Spironolactone for Pulmonary Arterial Hypertension
- NCT02143830 · 70 participants · Phase 2
HSCT for Patients With Fanconi Anemia Using Risk-Adjusted Chemotherapy
- NCT02601339 · 70 participants
NIRS Monitoring in Premature Infants
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia