Japanese BAY88-8223 Monotherapy Phase II Study

April 20, 2018 updated by: Bayer

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
49

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Chiba, Japan, 260-8717
      • Fukuoka, Japan, 812-8582
      • Kumamoto, Japan, 860-0008
      • Okayama, Japan, 700-8558
    • Chiba
      • Kashiwa, Chiba, Japan, 277-8577
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 003-0804
      • Sapporo, Hokkaido, Japan, 060-8543
    • Ishikawa
      • Kanazawa, Ishikawa, Japan, 920-8641
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 236-0004
    • Miyagi
      • Sendai, Miyagi, Japan, 980-8574
    • Osaka
      • Osakasayama, Osaka, Japan, 589-8511
    • Shizuoka
      • Hamamatsu, Shizuoka, Japan, 431-3192
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-8603
      • Bunkyo-ku, Tokyo, Japan, 113-8431
      • Koto-ku, Tokyo, Japan, 135-8550
      • Shinjuku-ku, Tokyo, Japan, 160-8582

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Radium-223 dichloride
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Percentage of change in total alkaline phosphatase from baseline at 12 weeks
Time Frame: Baseline and 12 weeks
Baseline and 12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Overall survival
Time Frame: 3 years
3 years
Percentage of change in total alkaline phosphatase at the end of treatment
Time Frame: Baseline and 24 weeks
Baseline and 24 weeks
Percentages of change in bone ALP at 12 weeks
Time Frame: Baseline and 12 weeks
Baseline and 12 weeks
Percentages of change in bone ALP at the end of treatment
Time Frame: Baseline and 24 weeks
Baseline and 24 weeks
The proportion of subjects who have total alkaline phosphatase normalization at 12 weeks
Time Frame: 12 weeks
12 weeks
The proportion of subjects who have total alkaline phosphatase normalization at the end of treatment
Time Frame: 24 weeks
24 weeks
The proportion of subjects who have bone alkaline phosphatase normalization at 12 weeks
Time Frame: 12 weeks
12 weeks
The proportion of subjects who have bone alkaline phosphatase normalization at the end of treatment
Time Frame: 24 weeks
24 weeks
Time to prostate specific antigen progression
Time Frame: 24 weeks
24 weeks
Percentages of change in biomarkers of bone turnover at each time point
Time Frame: Baseline and 36 weeks
Baseline and 36 weeks
Number of participants with drug related adverse events and serious adverse events as a measure of safety and tolerability
Time Frame: 3 years
3 years
Incidence of treatment-emergent adverse events (TEAEs)
Time Frame: 24 weeks plus 30 days
24 weeks plus 30 days
Number of participants with abnormal laboratory values
Time Frame: 36 weeks
36 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 30, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 16, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 16, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 23, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 28, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 24, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 16430

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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