check_circleStudy Completed

Prostatic Neoplasms

Bayer Identifier:

16430

ClinicalTrials.gov Identifier:

NCT01929655

EudraCT Number:

Not Available

EU CT Number:

Not Available
Japanese BAY88-8223 monotherapy Phase II study

Trial purpose

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

Key Participants Requirements

Sex

Male

Age

20 - N/A
  • - 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.
  • :
    - Treatment with cytotoxic chemotherapy within previous 4 weeks, or planned during the treatment period
    - History of visceral metastasis, or presence of visceral metastasis

Trial summary

Enrollment Goal
49
Trial Dates
September 2013 - May 2017
Phase
Phase 2
Could I Receive a placebo
No
Products
Xofigo (Radium-223 dichloride, BAY88-8223)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Yokohama, 236-0004, Japan
Completed
Kashiwa, 277-8577, Japan
Completed
Osakasayama, 589-8511, Japan
Completed
Kanazawa, 920-8641, Japan
Completed
Fukuoka, 812-8582, Japan
Completed
Shinjuku-ku, 160-8582, Japan
Completed
Hamamatsu, 431-3192, Japan
Completed
Bunkyo-ku, 113-8431, Japan
Withdrawn
Suita, 565-0871, Japan
Completed
Sapporo, 060-8543, Japan
Completed
Bunkyo-ku, 113-8603, Japan
Completed
Koto-ku, 135-8550, Japan
Completed
Okayama, 700-8558, Japan
Completed
Sendai, 980-8574, Japan
Completed
Chiba, 260-8717, Japan
Completed
Sapporo, 003-0804, Japan
Completed
Kumamoto, 860-0008, Japan

Primary Outcome

  • Percentage of change in total alkaline phosphatase from baseline at 12 weeks
    date_rangeTime Frame:
    Baseline and 12 weeks
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Percentage of change in total alkaline phosphatase at the end of treatment
    date_rangeTime Frame:
    Baseline and 24 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Percentages of change in bone ALP at 12 weeks
    date_rangeTime Frame:
    Baseline and 12 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Percentages of change in bone ALP at the end of treatment
    date_rangeTime Frame:
    Baseline and 24 weeks
    enhanced_encryption
    Safety Issue:
    No
  • The proportion of subjects who have total alkaline phosphatase normalization at 12 weeks
    date_rangeTime Frame:
    12 weeks
    enhanced_encryption
    Safety Issue:
    No
  • The proportion of subjects who have total alkaline phosphatase normalization at the end of treatment
    date_rangeTime Frame:
    24 weeks
    enhanced_encryption
    Safety Issue:
    No
  • The proportion of subjects who have bone alkaline phosphatase normalization at 12 weeks
    date_rangeTime Frame:
    12 weeks
    enhanced_encryption
    Safety Issue:
    No
  • The proportion of subjects who have bone alkaline phosphatase normalization at the end of treatment
    date_rangeTime Frame:
    24 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Time to prostate specific antigen progression
    date_rangeTime Frame:
    24 weeks
    enhanced_encryption
    Safety Issue:
    No
  • Overall survival
    date_rangeTime Frame:
    3 years
    enhanced_encryption
    Safety Issue:
    No
  • Percentages of change in biomarkers of bone turnover at each time point
    date_rangeTime Frame:
    Baseline and 36 weeks
    enhanced_encryption
    Safety Issue:
    Yes
  • Number of participants with drug related adverse events and serious adverse events as a measure of safety and tolerability
    date_rangeTime Frame:
    3 years
  • Incidence of treatment-emergent adverse events (TEAEs)
    date_rangeTime Frame:
    24 weeks plus 30 days
  • Number of participants with abnormal laboratory values
    date_rangeTime Frame:
    36 weeks

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
N/A
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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