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Generated: December 11, 2018

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CLINICAL TRIALS PROFILE FOR XOFIGO

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Clinical Trials for Xofigo

Trial ID Title Status Sponsor Phase Summary
NCT00667199 BAY88-8223, Does Response Study in HRPC Patients Completed Bayer Phase 2 The purpose of this study is to evaluate the efficacy and safety of the investigational radioisotope Radium-223, Xofigo (Alpharadin), in treatment of men with prostate cancer and bone metastases that no longer respond to hormonal treatment.
NCT00667537 PK in Pts With HRPC & Skeletal Metastes Completed Bayer Phase 1 Primary objective: To investigate the biodistribution, radiation dosimetry, and pharmacokinetics of two separate intravenous (IV) injections of Xofigo (100 kBq/kg body weight [b.w.] [=110 kBq/kg based on the 2015 National Institute of Standards and Technology standardization], 6 weeks apart). Secondary objectives: To determine the safety of IV injections of Xofigo after two separate injections (6 weeks apart), to evaluate treatment response (antitumour effect in osteoblastic bone metastases) of Xofigo treatment consisting of two injections of activity 100 kBq/kg b.w. (=110 kBq/kg based on the 2015 National Institute of Standards and Technology standardization), 6 weeks apart and to evaluate long term radiation toxicity and to collect survival data at 6 and 12 months after the first injection
NCT00748046 Alpharadin™ (Radium-223 Chloride) Safety and Dosimetry With HRPC That Has Metastasized to the Skeleton Completed Bayer Phase 1 The purpose of the study is to investigate the safety, biodistribution, radiation dosimetry and pharmacokinetics of three intravenous escalating dose levels of Xofigo (Alpharadin).
NCT01070485 BAY88-8223, Alpharadin, Breast Cancer Patients With Bone Dominant Disease Completed Bayer Phase 2 The purpose of the study is to investigate if multiple (up to four) intravenous injections of Xofigo (Alpharadin) have any clinically relevant effect on bone markers in breast cancer patients with bone dominant disease who have progressed on endocrine therapy and are no longer considered suitable for endocrine therapy. In addition the safety of Xofigo (Alpharadin) will be assessed.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Xofigo

Condition Name

Condition Name for Xofigo
Intervention Trials
Prostate Cancer 4
Prostatic Neoplasms, Castration-Resistant 3
Bone Metastases 3
Prostate Adenocarcinoma 2
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Condition MeSH

Condition MeSH for Xofigo
Intervention Trials
Prostatic Neoplasms 15
Neoplasm Metastasis 8
Bone Neoplasms 5
Bone Marrow Diseases 5
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Clinical Trial Locations for Xofigo

Trials by Country

Trials by Country for Xofigo
Location Trials
United States 9
Germany 2
United Kingdom 2
Japan 1
Netherlands 1
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Trials by US State

Trials by US State for Xofigo
Location Trials
California 3
Texas 2
Massachusetts 1
Pennsylvania 1
New Jersey 1
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Clinical Trial Progress for Xofigo

Clinical Trial Phase

Clinical Trial Phase for Xofigo
Clinical Trial Phase Trials
Phase 3 1
Phase 2 8
Phase 1/Phase 2 2
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Clinical Trial Status

Clinical Trial Status for Xofigo
Clinical Trial Phase Trials
Recruiting 7
Not yet recruiting 6
Completed 4
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Clinical Trial Sponsors for Xofigo

Sponsor Name

Sponsor Name for Xofigo
Sponsor Trials
Bayer 12
National Cancer Institute (NCI) 2
M.D. Anderson Cancer Center 2
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Sponsor Type

Sponsor Type for Xofigo
Sponsor Trials
Industry 14
Other 11
NIH 2
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Harvard Business School
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Cerilliant
UBS

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