Trial Condition(s):
Prostatic Neoplasms
Japanese BAY88-8223 monotherapy Phase II study
Bayer Identifier:
16430
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Investigative Site Yokohama, Japan, 236-0004 | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Kashiwa, Japan, 277-8577 | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Osakasayama, Japan, 589-8511 | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Kanazawa, Japan, 920-8641 | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Fukuoka, Japan, 812-8582 | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Shinjuku-ku, Japan, 160-8582 | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Hamamatsu, Japan, 431-3192 | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Bunkyo-ku, Japan, 113-8431 | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Sapporo, Japan, 060-8543 | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Bunkyo-ku, Japan, 113-8603 | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Koto-ku, Japan, 135-8550 | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Okayama, Japan, 700-8558 | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Sendai, Japan, 980-8574 | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Chiba, Japan, 260-8717 | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Sapporo, Japan, 003-0804 | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
Locations Investigative Site Kumamoto, Japan, 860-0008 | Status Completed | Contact Us: E-mail: [email protected] Phone: +49 30 300139003 |
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
Primary Outcome
- Percentage of change in total alkaline phosphatase from baseline at 12 weeksTimeframe: Baseline and 12 weeks
Secondary Outcome
- Percentage of change in total alkaline phosphatase at the end of treatmentTimeframe: Baseline and 24 weeks
- Percentages of change in bone ALP at 12 weeksTimeframe: Baseline and 12 weeks
- Percentages of change in bone ALP at the end of treatmentTimeframe: Baseline and 24 weeks
- The proportion of subjects who have total alkaline phosphatase normalization at 12 weeksTimeframe: 12 weeks
- The proportion of subjects who have total alkaline phosphatase normalization at the end of treatmentTimeframe: 24 weeks
- The proportion of subjects who have bone alkaline phosphatase normalization at 12 weeksTimeframe: 12 weeks
- The proportion of subjects who have bone alkaline phosphatase normalization at the end of treatmentTimeframe: 24 weeks
- Time to prostate specific antigen progressionTimeframe: 24 weeks
- Overall survivalTimeframe: 3 years
- Percentages of change in biomarkers of bone turnover at each time pointTimeframe: Baseline and 36 weeks
- Number of participants with drug related adverse events and serious adverse events as a measure of safety and tolerabilityTimeframe: 3 years
- Incidence of treatment-emergent adverse events (TEAEs)Timeframe: 24 weeks plus 30 days
- Number of participants with abnormal laboratory valuesTimeframe: 36 weeks
Additional Information
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