Safety, Biodistribution, Radiation Dosimetry and Pharmacokinetics Study of BAY88-8223 in Japanese Patients

Study Overview
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Brief Summary
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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.

Official Title
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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
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Prostatic Neoplasms

Intervention / Treatment
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* Drug: Radium-223 dichloride (Xofigo, BAY88-8223)
* Drug: Radium-223 dichloride (Xofigo, BAY88-8223)
* Drug: Radium-223 dichloride (Xofigo, BAY88-8223)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Radium-223 dichloride [50 kBq/kg]<br> | Drug: Radium-223 dichloride (Xofigo, BAY88-8223)<br>* Radium-223 dichloride (Xofigo, BAY88-8223) 50 kBq/kg<br>|
| Experimental: Radium-223 dichloride [100 kBq/kg]<br> | Drug: Radium-223 dichloride (Xofigo, BAY88-8223)<br>* Radium-223 dichloride (Xofigo, BAY88-8223) 100 kBq/kg<br>|
| Experimental: Radium-223 dichloride [expansion]<br> | Drug: Radium-223 dichloride (Xofigo, BAY88-8223)<br>* Expansion arm: Radium-223 dichloride (Xofigo, BAY88-8223) 50 kBq/kg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with Critical toxicities | Critical toxicities (using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0) will be defined as the occurrence of one or more of the following drug-related toxicities: 1) ≥Grade 3 non-hematologic toxicity, 2) Grade 3 neutropenia with fever, 3) Grade 4 neutropenia that failed to recover to grade 2 or less after treatment with Granulocyte colony-stimulating factor (GCSF) within 2 weeks, 4) Grade 4 thrombocytopenia | Up to day 28 | 
| Maximum drug concentration in blood after single dose administration (Cmax) of BAY88-8223 for blood samples |  | up to 72 hours | 
| Area under the concentration - time curve (AUC) of BAY88-8223 for blood samples |  | up to 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in prostate specific antigen (PSA) |  | baseline, up to 12 weeks | 
| Overall Survival |  | Up to 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BAY88-8223, radium-223 dichloride, prostate cancer