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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
19
Radium-223 dichloride (Xofigo, BAY88-8223) 50 kBq/kg
Radium-223 dichloride (Xofigo, BAY88-8223) 100 kBq/kg
Expansion arm: Radium-223 dichloride (Xofigo, BAY88-8223) 50 kBq/kg
Unnamed facility
Kashiwa, Chiba, Japan
Unnamed facility
Yokohama, Kanagawa, Japan
Unnamed facility
Sayama, Osaka, Japan
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
Time frame: Up to day 28
Maximum drug concentration in blood after single dose administration (Cmax) of BAY88-8223 for blood samples
Time frame: up to 72 hours
Area under the concentration - time curve (AUC) of BAY88-8223 for blood samples
Time frame: up to 72 hours
Changes in prostate specific antigen (PSA)
Time frame: baseline, up to 12 weeks
Overall Survival
Time frame: Up to 36 months
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