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To evaluate the efficacy and safety of the best standard of care plus BAY88-8223 in Japanese patients with CRPC and bone metastases after a multiple administration
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radium-223 dichloride | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radium-223 dichloride (Xofigo, BAY88-8223) | Drug | BAY88-8223, 50 kBq/kg will be administered as slow bolus intravenous injection 6 times at intervals of 4 weeks between each administration |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of change in total alkaline phosphatase from baseline at 12 weeks | Baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of change in total alkaline phosphatase at the end of treatment | Baseline and 24 weeks | |
| Percentages of change in bone ALP at 12 weeks | Baseline and 12 weeks | |
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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 |
|---|---|---|---|
| 28770408 | Derived | Matsubara N, Nagamori S, Wakumoto Y, Uemura H, Kimura G, Yokomizo A, Kikukawa H, Mizokami A, Kosaka T, Masumori N, Kawasaki Y, Yonese J, Nasu Y, Fukasawa S, Sugiyama T, Kinuya S, Hosono M, Yamaguchi I, Tsutsui H, Uemura H. Phase II study of radium-223 dichloride in Japanese patients with symptomatic castration-resistant prostate cancer. Int J Clin Oncol. 2018 Feb;23(1):173-180. doi: 10.1007/s10147-017-1176-0. Epub 2017 Aug 2. |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C581106 | radium Ra 223 dichloride |
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| Percentages of change in bone ALP at the end of treatment |
| Baseline and 24 weeks |
| The proportion of subjects who have total alkaline phosphatase normalization at 12 weeks | 12 weeks |
| The proportion of subjects who have total alkaline phosphatase normalization at the end of treatment | 24 weeks |
| The proportion of subjects who have bone alkaline phosphatase normalization at 12 weeks | 12 weeks |
| The proportion of subjects who have bone alkaline phosphatase normalization at the end of treatment | 24 weeks |
| Time to prostate specific antigen progression | 24 weeks |
| Overall survival | 3 years |
| Percentages of change in biomarkers of bone turnover at each time point | Baseline and 36 weeks |
| Number of participants with drug related adverse events and serious adverse events as a measure of safety and tolerability | 3 years |
| Incidence of treatment-emergent adverse events (TEAEs) | 24 weeks plus 30 days |
| Number of participants with abnormal laboratory values | 36 weeks |
| Sapporo |
| Hokkaido |
| 003-0804 |
| Japan |
| Sapporo | Hokkaido | 060-8543 | Japan |
| Kanazawa | Ishikawa-ken | 920-8641 | Japan |
| Yokohama | Kanagawa | 236-0004 | Japan |
| Sendai | Miyagi | 980-8574 | Japan |
| Sayama | Osaka | 589-8511 | Japan |
| Hamamatsu | Shizuoka | 431-3192 | Japan |
| Bunkyo-ku | Tokyo | 113-8431 | Japan |
| Bunkyo-ku | Tokyo | 113-8603 | Japan |
| Koto-ku | Tokyo | 135-8550 | Japan |
| Shinjuku-ku | Tokyo | 160-8582 | Japan |
| Chiba | 260-8717 | Japan |
| Fukuoka | 812-8582 | Japan |
| Kumamoto | 860-0008 | Japan |
| Okayama | 700-8558 | Japan |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |