Study Completed

Prostatic Neoplasms

Bayer Identifier:

16430

ClinicalTrials.gov Identifier:

NCT01929655

EudraCT Number:

Not Available

EU CT Number:

Not Available

Japanese BAY88-8223 monotherapy Phase II study

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

Key Participants Requirements

Sex

Male

Age

20 - N/A

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

Trial Dates

September 2013 - May 2017

Phase

Phase 2

Could I Receive a placebo

Products

Xofigo (Radium-223 dichloride, BAY88-8223)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed		Yokohama, 236-0004, Japan
Completed		Kashiwa, 277-8577, Japan
Completed		Osakasayama, 589-8511, Japan
Completed		Kanazawa, 920-8641, Japan
Completed		Fukuoka, 812-8582, Japan
Completed		Shinjuku-ku, 160-8582, Japan
Completed		Hamamatsu, 431-3192, Japan
Completed		Bunkyo-ku, 113-8431, Japan
Withdrawn		Suita, 565-0871, Japan
Completed		Sapporo, 060-8543, Japan
Completed		Bunkyo-ku, 113-8603, Japan
Completed		Koto-ku, 135-8550, Japan
Completed		Okayama, 700-8558, Japan
Completed		Sendai, 980-8574, Japan
Completed		Chiba, 260-8717, Japan
Completed		Sapporo, 003-0804, Japan
Completed		Kumamoto, 860-0008, Japan

Primary Outcome

Percentage of change in total alkaline phosphatase from baseline at 12 weeks
Time Frame:
Baseline and 12 weeks
Safety Issue:
No

Secondary Outcome

Percentage of change in total alkaline phosphatase at the end of treatment
Time Frame:
Baseline and 24 weeks
Safety Issue:
No
Percentages of change in bone ALP at 12 weeks
Time Frame:
Baseline and 12 weeks
Safety Issue:
No
Percentages of change in bone ALP at the end of treatment
Time Frame:
Baseline and 24 weeks
Safety Issue:
No
The proportion of subjects who have total alkaline phosphatase normalization at 12 weeks
Time Frame:
12 weeks
Safety Issue:
No
The proportion of subjects who have total alkaline phosphatase normalization at the end of treatment
Time Frame:
24 weeks
Safety Issue:
No
The proportion of subjects who have bone alkaline phosphatase normalization at 12 weeks
Time Frame:
12 weeks
Safety Issue:
No
The proportion of subjects who have bone alkaline phosphatase normalization at the end of treatment
Time Frame:
24 weeks
Safety Issue:
No
Time to prostate specific antigen progression
Time Frame:
24 weeks
Safety Issue:
No
Overall survival
Time Frame:
3 years
Safety Issue:
No
Percentages of change in biomarkers of bone turnover at each time point
Time Frame:
Baseline and 36 weeks
Safety Issue:
Yes
Number of participants with drug related adverse events and serious adverse events as a measure of safety and tolerability
Time Frame:
3 years
Incidence of treatment-emergent adverse events (TEAEs)
Time Frame:
24 weeks plus 30 days
Number of participants with abnormal laboratory values
Time Frame:
36 weeks

Trial design

A single-arm, open-label, multicenter, phase II study of BAY88-8223 in the treatment of Japanese patients with symptomatic castration-resistant prostate cancer (CRPC) with bone metastases

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Treatment

Allocation

N/A

Blinding

Open Label

Assignment

Single Group Assignment

Trial Arms

Additional Information

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