Trial Condition(s):

Prostatic Neoplasms

Safety, biodistribution, radiation dosimetry and pharmacokinetics study of BAY88-8223 in Japanese patients

Bayer Identifier:

15354

ClinicalTrials.gov Identifier:

NCT01565746

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

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

Trial Summary

Enrollment Goal
19
Trial Dates
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Phase
1
Could I receive a placebo?
No
Products
Xofigo (Radium-223 dichloride, BAY88-8223)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Kashiwa, Japan, 277-8577

Status
Completed
 
Locations

Investigative Site

Yokohama, Japan, 236-0004

Status
Completed
 
Locations

Investigative Site

Osakasayama, Japan, 589-8511

Status
Completed
 

Trial Design