Clinical trial NCT01929655: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Prostatic Neoplasms
Keywords: Phase II
symptomatic castration-resistant prostate cancer
bone metastases
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2013-08-28
Enrollment: 49
Sex: MALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Percentage of change in total alkaline phosphatase from baseline at 12 weeks
timeFrame: Baseline and 12 weeks
Secondary outcomes:
measure: Percentage of change in total alkaline phosphatase at the end of treatment
timeFrame: Baseline and 24 weeks
measure: Percentages of change in bone ALP at 12 weeks
timeFrame: Baseline and 12 weeks
measure: Percentages of change in bone ALP at the end of treatment
timeFrame: Baseline and 24 weeks
measure: The proportion of subjects who have total alkaline phosphatase normalization at 12 weeks
timeFrame: 12 weeks
measure: The proportion of subjects who have total alkaline phosphatase normalization at the end of treatment
timeFrame: 24 weeks
measure: The proportion of subjects who have bone alkaline phosphatase normalization at 12 weeks
timeFrame: 12 weeks
measure: The proportion of subjects who have bone alkaline phosphatase normalization at the end of treatment
timeFrame: 24 weeks
measure: Time to prostate specific antigen progression
timeFrame: 24 weeks
measure: Overall survival
timeFrame: 3 years
measure: Percentages of change in biomarkers of bone turnover at each time point
timeFrame: Baseline and 36 weeks
measure: Number of participants with drug related adverse events and serious adverse events as a measure of safety and tolerability
timeFrame: 3 years
measure: Incidence of treatment-emergent adverse events (TEAEs)
timeFrame: 24 weeks plus 30 days
measure: Number of participants with abnormal laboratory values
timeFrame: 36 weeks
Other outcomes:
Locations:
city: Kashiwa
country: Japan
state: Chiba
city: Sapporo
country: Japan
state: Hokkaido
city: Sapporo
country: Japan
state: Hokkaido
city: Kanazawa
country: Japan
state: Ishikawa
city: Yokohama
country: Japan
state: Kanagawa
city: Sendai
country: Japan
state: Miyagi
city: Osakasayama
country: Japan
state: Osaka
city: Hamamatsu
country: Japan
state: Shizuoka
city: Bunkyo-ku
country: Japan
state: Tokyo
city: Bunkyo-ku
country: Japan
state: Tokyo
city: Koto-ku
country: Japan
state: Tokyo
city: Shinjuku-ku
country: Japan
state: Tokyo
city: Chiba
country: Japan
city: Fukuoka
country: Japan
city: Kumamoto
country: Japan
city: Okayama
country: Japan
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
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.