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Japanese BAY88-8223 Monotherapy Phase II Study

Primary Purpose

Prostatic Neoplasms

Status

Completed

Phase

Phase 2

Locations

Japan

Study Type

Interventional

Intervention

Radium-223 dichloride (Xofigo, BAY88-8223)

About this trial

This is an interventional treatment trial for Prostatic Neoplasms focused on measuring Phase II, symptomatic castration-resistant prostate cancer, bone metastases

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Radium-223 dichloride

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Percentages of change in bone ALP at 12 weeks

Percentages of change in bone ALP at the end of treatment

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

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

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

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

Time to prostate specific antigen progression

Overall survival

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

Number of participants with drug related adverse events and serious adverse events as a measure of safety and tolerability

Incidence of treatment-emergent adverse events (TEAEs)

Number of participants with abnormal laboratory values

Full Information

NCT ID

NCT01929655

First Posted

August 23, 2013

Last Updated

April 20, 2018

Sponsor

Bayer

1. Study Identification

Unique Protocol Identification Number

NCT01929655

Brief Title

Japanese BAY88-8223 Monotherapy Phase II Study

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Completed

Study Start Date

September 30, 2013 (Actual)

Primary Completion Date

May 16, 2017 (Actual)

Study Completion Date

May 16, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bayer

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostatic Neoplasms

Keywords

Phase II, symptomatic castration-resistant prostate cancer, bone metastases

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

49 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Radium-223 dichloride

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Radium-223 dichloride (Xofigo, BAY88-8223)

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

Baseline and 12 weeks

Secondary Outcome Measure Information:

Title

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

Time Frame

Baseline and 24 weeks

Title

Percentages of change in bone ALP at 12 weeks

Time Frame

Baseline and 12 weeks

Title

Percentages of change in bone ALP at the end of treatment

Time Frame

Baseline and 24 weeks

Title

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

Time Frame

12 weeks

Title

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

Time Frame

24 weeks

Title

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

Time Frame

12 weeks

Title

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

Time Frame

24 weeks

Title

Time to prostate specific antigen progression

Time Frame

24 weeks

Title

Overall survival

Time Frame

3 years

Title

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

Time Frame

Baseline and 36 weeks

Title

Number of participants with drug related adverse events and serious adverse events as a measure of safety and tolerability

Time Frame

3 years

Title

Incidence of treatment-emergent adverse events (TEAEs)

Time Frame

24 weeks plus 30 days

Title

Number of participants with abnormal laboratory values

Time Frame

36 weeks

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bayer Study Director

Organizational Affiliation

Bayer

Official's Role

Study Director

Facility Information:

City

Kashiwa

State/Province

Chiba

ZIP/Postal Code

277-8577

Country

Japan

City

Sapporo

State/Province

Hokkaido

ZIP/Postal Code

003-0804

Country

Japan

City

Sapporo

State/Province

Hokkaido

ZIP/Postal Code

060-8543

Country

Japan

City

Kanazawa

State/Province

Ishikawa

ZIP/Postal Code

920-8641

Country

Japan

City

Yokohama

State/Province

Kanagawa

ZIP/Postal Code

236-0004

Country

Japan

City

Sendai

State/Province

Miyagi

ZIP/Postal Code

980-8574

Country

Japan

City

Osakasayama

State/Province

Osaka

ZIP/Postal Code

589-8511

Country

Japan

City

Hamamatsu

State/Province

Shizuoka

ZIP/Postal Code

431-3192

Country

Japan

City

Bunkyo-ku

State/Province

Tokyo

ZIP/Postal Code

113-8431

Country

Japan

City

Bunkyo-ku

State/Province

Tokyo

ZIP/Postal Code

113-8603

Country

Japan

City

Koto-ku

State/Province

Tokyo

ZIP/Postal Code

135-8550

Country

Japan

City

Shinjuku-ku

State/Province

Tokyo

ZIP/Postal Code

160-8582

Country

Japan

City

Chiba

ZIP/Postal Code

260-8717

Country

Japan

City

Fukuoka

ZIP/Postal Code

812-8582

Country

Japan

City

Kumamoto

ZIP/Postal Code

860-0008

Country

Japan

City

Okayama

ZIP/Postal Code

700-8558

Country

Japan

12. IPD Sharing Statement

Citations:

PubMed Identifier

28770408

Citation

Matsubara N, Nagamori S, Wakumoto Y, Uemura H, Kimura G, Yokomizo A, Kikukawa H, Mizokami A, Kosaka T, Masumori N, Kawasaki Y, Yonese J, Nasu Y, Fukasawa S, Sugiyama T, Kinuya S, Hosono M, Yamaguchi I, Tsutsui H, Uemura H. Phase II study of radium-223 dichloride in Japanese patients with symptomatic castration-resistant prostate cancer. Int J Clin Oncol. 2018 Feb;23(1):173-180. doi: 10.1007/s10147-017-1176-0. Epub 2017 Aug 2.

Results Reference

derived

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Japanese BAY88-8223 Monotherapy Phase II Study

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