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

Phase 1

Completed

• Conditions: Prostatic Neoplasms
• Interventions: Drug: Radium-223 dichloride (Xofigo, BAY88-8223)

• Registration Number: NCT01565746
• Lead Sponsor: Bayer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-03-01
• Study First Submitted QC: 2012-03-27
• Study First Posted: 2012-03-29
• Primary Completion: 2012-10
• Study Completion: 2016-04
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-14
• Last Update Posted: 2016-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 19

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Radium-223 dichloride [50 kBq/kg]	Radium-223 dichloride (Xofigo, BAY88-8223)	-
Radium-223 dichloride [100 kBq/kg]	Radium-223 dichloride (Xofigo, BAY88-8223)	-
Radium-223 dichloride [expansion]	Radium-223 dichloride (Xofigo, BAY88-8223)	-

Primary Outcome Measures

Name	Time	Method
Area under the concentration - time curve (AUC) of BAY88-8223 for blood samples	up to 72 hours
Number of participants with Critical toxicities	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
Maximum drug concentration in blood after single dose administration (Cmax) of BAY88-8223 for blood samples	up to 72 hours

Secondary Outcome Measures

Name	Time	Method
Changes in prostate specific antigen (PSA)	baseline, up to 12 weeks
Overall Survival	Up to 36 months