Clinical trial · Interventional
Safety, Biodistribution, Radiation Dosimetry and Pharmacokinetics Study of BAY88-8223 in Japanese Patients
Uncontrolled, Open-label, Non-randomized Phase I Study to Investigate Safety, Biodistribution, Radiation Dosimetry and Pharmacokinetics of a Single Dose of BAY88-8223 in Japanese Patients With Castration-resistant Prostate Cancer and Bone Metastases
NCT01565746CI-TRIAL-00024316completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is an uncontrolled, open-label, non-randomized Phase I study to investigate safety, biodistribution, radiation dosimetry and pharmacokinetics of a single dose of BAY88-8223 in Japanese patients with castration-resistant prostate cancer and bone metastases.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radium-223 dichloride (Xofigo, BAY88-8223) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Radium-223 dichloride [50 kBq/kg]
- interventionNames
- Drug: Radium-223 dichloride (Xofigo, BAY88-8223)
- type
- EXPERIMENTAL
- label
- Radium-223 dichloride [100 kBq/kg]
- interventionNames
- Drug: Radium-223 dichloride (Xofigo, BAY88-8223)
- type
- EXPERIMENTAL
- label
- Radium-223 dichloride [expansion]
- interventionNames
- Drug: Radium-223 dichloride (Xofigo, BAY88-8223)
Primary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Male ≥ 20 years of age * Histologically or cytologically confirmed adenocarcinoma of the prostate * Presents with at least 2 bone metastases, confirmed by scintigraphic imaging within the previous 4 weeks * Patients who has failed initial hormonal therapy using either an orchiectomy or a Gonadotropin releasing hormone (GnRH) agonist in combination with an antiandrogen must first progress through antiandrogen withdrawal prior to being eligible. The minimum timeframe to document failure of anti-androgen withdrawal will be four weeks * Progressive castration resistant metastatic disease * Castrate level of testosterone (\<50 ng/dL), treatment to maintain castrate levels of testosterone must be continued Exclusion Criteria: * Has received an investigational drug in the 4 weeks before or is scheduled to receiving one during or in the 8 weeks after study drug administration. * Has received chemo-, immuno-, or radiotherapy within the last 4 weeks prior to entry in the study, or has not recovered from acute adverse events as a result of such therapy * Has received prior hemibody external radiotherapy * Has a need for immediate external radiotherapy * Has received systemic radiotherapy with radium-223, strontium-89, samarium-153, rhenium-186 or rhenium-188 for the treatment of bony metastases within the last 24 weeks prior to administration of study drug * When receiving bisphosphonates, has changed the dose within 4 weeks before administration of study drug
References
Publications (2)
- RESULTYoshida K, Kaneta T, Takano S, Sugiura M, Kawano T, Hino A, Yamamoto T, Shizukuishi K, Kaneko M, Zurth C, Inoue T. Pharmacokinetics of single dose radium-223 dichloride (BAY 88-8223) in Japanese patients with castration-resistant prostate cancer and bone metastases. Ann Nucl Med. 2016 Aug;30(7):453-60. doi: 10.1007/s12149-016-1093-8. Epub 2016 Jun 7. PMID 27272279
- DERIVEDUemura H, Uemura H, Matsubara N, Kinuya S, Hosono M, Yajima Y, Doi T. Safety and efficacy of radium-223 dichloride in Japanese patients with castration-resistant prostate cancer and bone metastases. Int J Clin Oncol. 2017 Oct;22(5):954-963. doi: 10.1007/s10147-017-1130-1. Epub 2017 May 6. PMID 28478485