Japanese BAY88-8223 Monotherapy Phase II Study

Phase 2

Completed

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

• Registration Number: NCT01929655
• Lead Sponsor: Bayer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-08-23
• Study First Submitted QC: 2013-08-27
• Study First Posted: 2013-08-28
• Study Start: 2013-09-30
• Primary Completion: 2017-05-16
• Study Completion: 2017-05-16
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-20
• Last Update Posted: 2018-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 49

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

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Radium-223 dichloride	Radium-223 dichloride (Xofigo, BAY88-8223)	-

Primary Outcome Measures

Name	Time	Method
Percentage of change in total alkaline phosphatase from baseline at 12 weeks	Baseline and 12 weeks

Secondary Outcome Measures

Name	Time	Method
The proportion of subjects who have bone alkaline phosphatase normalization at the end of treatment	24 weeks
The proportion of subjects who have total alkaline phosphatase normalization at 12 weeks	12 weeks
Percentage of change in total alkaline phosphatase at the end of treatment	Baseline and 24 weeks
Percentages of change in bone ALP at 12 weeks	Baseline and 12 weeks
Overall survival	3 years
Number of participants with abnormal laboratory values	36 weeks
Percentages of change in bone ALP at the end of treatment	Baseline and 24 weeks
Percentages of change in biomarkers of bone turnover at each time point	Baseline and 36 weeks
The proportion of subjects who have bone alkaline phosphatase normalization at 12 weeks	12 weeks
Time to prostate specific antigen progression	24 weeks
The proportion of subjects who have total alkaline phosphatase normalization at the end of treatment	24 weeks
Number of participants with drug related adverse events and serious adverse events as a measure of safety and tolerability	3 years
Incidence of treatment-emergent adverse events (TEAEs)	24 weeks plus 30 days