Japanese BAY88-8223 Monotherapy Phase II Study

Phase 2CompletedNCT01929655

Bayer49 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Prostatic Neoplasms

Interventions

Radium-223 dichloride (Xofigo, BAY88-8223)DRUG

BAY88-8223, 50 kBq/kg will be administered as slow bolus intravenous injection 6 times at intervals of 4 weeks between each administration

Eligibility

Sex: MALEMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (16)

Unnamed facility

Kashiwa, Chiba, Japan

Unnamed facility

Sapporo, Hokkaido, Japan

Unnamed facility

Sapporo, Hokkaido, Japan

Outcomes

Primary Outcomes

Percentage of change in total alkaline phosphatase from baseline at 12 weeks

Time frame: Baseline and 12 weeks

Secondary Outcomes

Percentage of change in total alkaline phosphatase at the end of treatment

Time frame: Baseline and 24 weeks

Percentages of change in bone ALP at 12 weeks

Time frame: Baseline and 12 weeks

Percentages of change in bone ALP at the end of treatment

Time frame: Baseline and 24 weeks

The proportion of subjects who have total alkaline phosphatase normalization at 12 weeks

Time frame: 12 weeks

The proportion of subjects who have total alkaline phosphatase normalization at the end of treatment

Time frame: 24 weeks

The proportion of subjects who have bone alkaline phosphatase normalization at 12 weeks

Time frame: 12 weeks

The proportion of subjects who have bone alkaline phosphatase normalization at the end of treatment

Time frame: 24 weeks

Time to prostate specific antigen progression

Time frame: 24 weeks

Overall survival

Time frame: 3 years

Percentages of change in biomarkers of bone turnover at each time point

Data from ClinicalTrials.gov

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