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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01565746
Recruitment Status : Completed
First Posted : March 29, 2012
Last Update Posted : October 17, 2016
Information provided by (Responsible Party):

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Prostatic Neoplasms Drug: Radium-223 dichloride (Xofigo, BAY88-8223) Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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 Start Date : March 2012
Actual Primary Completion Date : October 2012
Actual Study Completion Date : April 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Radium-223 dichloride [50 kBq/kg] Drug: Radium-223 dichloride (Xofigo, BAY88-8223)
Radium-223 dichloride (Xofigo, BAY88-8223) 50 kBq/kg

Experimental: Radium-223 dichloride [100 kBq/kg] Drug: Radium-223 dichloride (Xofigo, BAY88-8223)
Radium-223 dichloride (Xofigo, BAY88-8223) 100 kBq/kg

Experimental: Radium-223 dichloride [expansion] Drug: Radium-223 dichloride (Xofigo, BAY88-8223)
Expansion arm: Radium-223 dichloride (Xofigo, BAY88-8223) 50 kBq/kg

Primary Outcome Measures :
  1. Number of participants with Critical toxicities [ Time Frame: Up to day 28 ]
    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

  2. Maximum drug concentration in blood after single dose administration (Cmax) of BAY88-8223 for blood samples [ Time Frame: up to 72 hours ]
  3. Area under the concentration - time curve (AUC) of BAY88-8223 for blood samples [ Time Frame: up to 72 hours ]

Secondary Outcome Measures :
  1. Changes in prostate specific antigen (PSA) [ Time Frame: baseline, up to 12 weeks ]
  2. Overall Survival [ Time Frame: Up to 36 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01565746

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Kashiwa, Chiba, Japan, 277-8577
Yokohama, Kanagawa, Japan, 236-0004
Osakasayama, Osaka, Japan, 589-8511
Sponsors and Collaborators
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Study Director: Bayer Study Director Bayer
Publications of Results:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Bayer Identifier: NCT01565746    
Other Study ID Numbers: 15354
First Posted: March 29, 2012    Key Record Dates
Last Update Posted: October 17, 2016
Last Verified: October 2016
Keywords provided by Bayer:
radium-223 dichloride
prostate cancer
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Prostatic Diseases
Radium Ra 223 dichloride
Antineoplastic Agents