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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radium-223 dichloride [50 kBq/kg] | Experimental |
| |
| Radium-223 dichloride [100 kBq/kg] | Experimental |
| |
| Radium-223 dichloride [expansion] | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radium-223 dichloride (Xofigo, BAY88-8223) | Drug | Radium-223 dichloride (Xofigo, BAY88-8223) 50 kBq/kg |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in prostate specific antigen (PSA) | baseline, up to 12 weeks | |
| Overall Survival | Up to 36 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kashiwa | Chiba | 277-8577 | Japan | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27272279 | Result | Yoshida 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. | |
| 28478485 |
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| Radium-223 dichloride (Xofigo, BAY88-8223) | Drug | Radium-223 dichloride (Xofigo, BAY88-8223) 100 kBq/kg |
|
| Radium-223 dichloride (Xofigo, BAY88-8223) | Drug | Expansion arm: Radium-223 dichloride (Xofigo, BAY88-8223) 50 kBq/kg |
|
| Yokohama |
| Kanagawa |
| 236-0004 |
| Japan |
| Sayama | Osaka | 589-8511 | Japan |
| Uemura 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. |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| C581106 | radium Ra 223 dichloride |
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