Prostatic NeoplasmsPhase 2NCT01929655
Japanese BAY88-8223 Monotherapy Phase II Study
A Phase 2 study testing Radium-223 dichloride (Xofigo, BAY88-8223) in people with Prostatic Neoplasms, run by Bayer at 16 sites in Japan.
Trial 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 Read more about this study
- Who is it for?
- Ages 20 years and older, men only
- Conditions the study is for
- Prostatic Neoplasms
- What is being tested?
- Radium-223 dichloride (Xofigo, BAY88-8223)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 16 sitesJapan
- Study dates
- 30 Sep 2013to 16 May 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Treatment with cytotoxic chemotherapy within previous 4 weeks, or planned during the treatment period
- History of visceral metastasis, or presence of visceral metastasis
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
Japan16 sites
Study site
Bunkyo-ku, Tokyo, 113-8431
Study site
Bunkyo-ku, Tokyo, 113-8603
Study site
Chiba, 260-8717
Study site
Fukuoka, 812-8582
Study site
Hamamatsu, Shizuoka, 431-3192
Study site
Kanazawa, Ishikawa-ken, 920-8641
Study site
Kashiwa, Chiba, 277-8577
Study site
Koto-ku, Tokyo, 135-8550
Study site
Kumamoto, 860-0008
Study site
Okayama, 700-8558
Study site
Sapporo, Hokkaido, 003-0804
Study site
Sapporo, Hokkaido, 060-8543
Study site
Sayama, Osaka, 589-8511
Study site
Sendai, Miyagi, 980-8574
Study site
Shinjuku-ku, Tokyo, 160-8582
Study site
Yokohama, Kanagawa, 236-0004
About this 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
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
- Conditions
- Prostatic Neoplasms
- Being tested
- Radium-223 dichloride (Xofigo, BAY88-8223)
- Keywords
- Phase II, symptomatic castration-resistant prostate cancer, bone metastases
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radium-223 dichloride (Xofigo, BAY88-8223)Drug
BAY88-8223, 50 kBq/kg will be administered as slow bolus intravenous injection 6 times at intervals of 4 weeks between each administration
| Study group | Role | What they receive |
|---|---|---|
| Radium-223 dichloride | Experimental | Not described Receives: Drug: Radium-223 dichloride (Xofigo, BAY88-8223) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of change in total alkaline phosphatase from baseline at 12 weeks
Measured: Baseline and 12 weeks
Secondary outcomes (13)
Percentage of change in total alkaline phosphatase at the end of treatment
Measured: Baseline and 24 weeks
Percentages of change in bone ALP at 12 weeks
Measured: Baseline and 12 weeks
Percentages of change in bone ALP at the end of treatment
Measured: Baseline and 24 weeks
The proportion of subjects who have total alkaline phosphatase normalization at 12 weeks
Measured: 12 weeks
The proportion of subjects who have total alkaline phosphatase normalization at the end of treatment
Measured: 24 weeks
The proportion of subjects who have bone alkaline phosphatase normalization at 12 weeks
Measured: 12 weeks
The proportion of subjects who have bone alkaline phosphatase normalization at the end of treatment
Measured: 24 weeks
Time to prostate specific antigen progression
Measured: 24 weeks
Overall survival
Measured: 3 years
Percentages of change in biomarkers of bone turnover at each time point
Measured: Baseline and 36 weeks
Number of participants with drug related adverse events and serious adverse events as a measure of safety and tolerability
Measured: 3 years
Incidence of treatment-emergent adverse events (TEAEs)
Measured: 24 weeks plus 30 days
Number of participants with abnormal laboratory values
Measured: 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2013 (estimated)
- Study start30 Sep 2013
- Primary completion16 May 2017
- Study completion16 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Prostatic NeoplasmsStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01929655
- Sponsor's protocol ID
- 16430
- Status last verified
- Apr 2018
- First submitted
- 23 Aug 2013
- Last updated
- 24 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 28770408
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01929655
- Acronym / sponsor ID
- 16430
- Conditions
- Prostatic Neoplasms
- Keywords
- Phase II, symptomatic castration-resistant prostate cancer, bone metastases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2013 (actual)
- Primary completion
- 16 May 2017 (actual)
- Study completion
- 16 May 2017 (actual)
- First posted
- 28 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radium-223 dichloride | Experimental | Drug: Radium-223 dichloride (Xofigo, BAY88-8223) |
Who may qualify
- Ages
- 20 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Treatment with cytotoxic chemotherapy within previous 4 weeks, or planned during the treatment period
- History of visceral metastasis, or presence of visceral metastasis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Drug | Radium-223 dichloride |
Primary outcome
Percentage of change in total alkaline phosphatase from baseline at 12 weeks
Time frame: Baseline and 12 weeks
13 secondary outcomes
Percentage of change in total alkaline phosphatase at the end of treatment
Time frame: Baseline and 24 weeks
Percentages of change in bone ALP at 12 weeks
Time frame: Baseline and 12 weeks
Percentages of change in bone ALP at the end of treatment
Time frame: Baseline and 24 weeks
The proportion of subjects who have total alkaline phosphatase normalization at 12 weeks
Time frame: 12 weeks
The proportion of subjects who have total alkaline phosphatase normalization at the end of treatment
Time frame: 24 weeks
The proportion of subjects who have bone alkaline phosphatase normalization at 12 weeks
Time frame: 12 weeks
The proportion of subjects who have bone alkaline phosphatase normalization at the end of treatment
Time frame: 24 weeks
Time to prostate specific antigen progression
Time frame: 24 weeks
Overall survival
Time frame: 3 years
Percentages of change in biomarkers of bone turnover at each time point
Time frame: Baseline and 36 weeks
Number of participants with drug related adverse events and serious adverse events as a measure of safety and tolerability
Time frame: 3 years
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: 24 weeks plus 30 days
Number of participants with abnormal laboratory values
Time frame: 36 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2018.
- Derived from this study: PubMed 28770408Matsubara 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Radium-223 dichloride (Xofigo, BAY88-8223) in people with Prostatic Neoplasms, run by Bayer at 16 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of change in total alkaline phosphatase from baseline at 12 weeks (time frame: Baseline and 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01929655, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2018.