Trial Condition(s):

Prostatic Neoplasms

Japanese BAY88-8223 monotherapy Phase II study

Bayer Identifier:

16430

ClinicalTrials.gov Identifier:

NCT01929655

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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

Inclusion Criteria
:
- Have received docetaxel or not eligible for the first course of docetaxel, i.e. patients who are not fit enough and willing.
- Histologically or cytologically confirmed adenocarcinoma of the prostate
- Multiple bone metastases
- Either regular (not occasional) analgesic medication use for cancer-related bone pain or treatment with external beam radiotherapy (EBRT) for bone pain.
 -  Best standard of care(BSoC) is regarded as the routine standard of care.
Exclusion Criteria
:
 - Treatment with cytotoxic chemotherapy within previous 4 weeks, or planned during the treatment period
- History of visceral metastasis, or presence of visceral metastasis

Trial Summary

Enrollment Goal
49
Trial Dates
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Phase
2
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

Yokohama, Japan, 236-0004

Status
Completed
 
Locations

Investigative Site

Kashiwa, Japan, 277-8577

Status
Completed
 
Locations

Investigative Site

Osakasayama, Japan, 589-8511

Status
Completed
 
Locations

Investigative Site

Kanazawa, Japan, 920-8641

Status
Completed
 
Locations

Investigative Site

Fukuoka, Japan, 812-8582

Status
Completed
 
Locations

Investigative Site

Shinjuku-ku, Japan, 160-8582

Status
Completed
 
Locations

Investigative Site

Hamamatsu, Japan, 431-3192

Status
Completed
 
Locations

Investigative Site

Bunkyo-ku, Japan, 113-8431

Status
Completed
 
Locations

Investigative Site

Sapporo, Japan, 060-8543

Status
Completed
 
Locations

Investigative Site

Bunkyo-ku, Japan, 113-8603

Status
Completed
 
Locations

Investigative Site

Koto-ku, Japan, 135-8550

Status
Completed
 
Locations

Investigative Site

Okayama, Japan, 700-8558

Status
Completed
 
Locations

Investigative Site

Sendai, Japan, 980-8574

Status
Completed
 
Locations

Investigative Site

Chiba, Japan, 260-8717

Status
Completed
 
Locations

Investigative Site

Sapporo, Japan, 003-0804

Status
Completed
 
Locations

Investigative Site

Kumamoto, Japan, 860-0008

Status
Completed
 

Trial Design