Japanese BAY88-8223 Monotherapy Phase II Study

Prostatic Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01929655
• Other study ID #: 16430
• Status: Completed
• Phase: Phase 2
• First received: August 23, 2013
• Last updated: April 20, 2018
• Start date: September 30, 2013
• Est. completion date: May 16, 2017

Study information

• Verified date: April 2018
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: May 16, 2017
• Est. primary completion date: May 16, 2017
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prostatic Neoplasms

Intervention

Drug:
• Radium-223 dichloride (Xofigo, BAY88-8223)
BAY88-8223, 50 kBq/kg will be administered as slow bolus intravenous injection 6 times at intervals of 4 weeks between each administration

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Japan, 

Outcome

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

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