Japanese BAY88-8223 Monotherapy Phase II Study

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: Completed
• Conditions: Prostatic Neoplasms
• Intervention / Treatment: Drug: Radium-223 dichloride (Xofigo, BAY88-8223)

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Phase 2

Contacts and Locations

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

Eligibility Criteria

• Ages Eligible for Study: 18 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Time Frame
Percentage of change in total alkaline phosphatase from baseline at 12 weeks	Baseline and 12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Overall survival	3 years
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
Percentages of change in bone ALP at the end of treatment	Baseline and 24 weeks
The proportion of subjects who have total alkaline phosphatase normalization at 12 weeks	12 weeks
The proportion of subjects who have total alkaline phosphatase normalization at the end of treatment	24 weeks
The proportion of subjects who have bone alkaline phosphatase normalization at 12 weeks	12 weeks
The proportion of subjects who have bone alkaline phosphatase normalization at the end of treatment	24 weeks
Time to prostate specific antigen progression	24 weeks
Percentages of change in biomarkers of bone turnover at each time point	Baseline and 36 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
Number of participants with abnormal laboratory values	36 weeks

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2013
• Primary Completion (Actual): May 16, 2017
• Study Completion (Actual): May 16, 2017

Study Registration Dates

• First Submitted: August 23, 2013
• First Submitted That Met QC Criteria: August 27, 2013
• First Posted (Estimate): August 28, 2013

Study Record Updates

• Last Update Posted (Actual): April 24, 2018
• Last Update Submitted That Met QC Criteria: April 20, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: bone metastases; Phase II; symptomatic castration-resistant prostate cancer
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Antineoplastic Agents; Radium Ra 223 dichloride
• Other Study ID 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