Prostatic NeoplasmsPhase 1NCT01565746
Safety, Biodistribution, Radiation Dosimetry and Pharmacokinetics Study of BAY88-8223 in Japanese Patients
A Phase 1 study testing Radium-223 dichloride (Xofigo, BAY88-8223) in people with Prostatic Neoplasms, run by Bayer at 3 sites in Japan.
Trial summary
This is an uncontrolled, open-label, non-randomized Phase I study to investigate safety, biodistribution, radiation dosimetry and pharmacokinetics of a single dose of BAY88-8223 in Japanese patients with castration-resistant prostate cancer and bone metastases. 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)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 3 sitesJapan
- Study dates
- Mar 2012to Apr 2016
- Phase
- Phase 1
- 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
- Male ≥ 20 years of age
- Histologically or cytologically confirmed adenocarcinoma of the prostate
- Presents with at least 2 bone metastases, confirmed by scintigraphic imaging within the previous 4 weeks
- Patients who has failed initial hormonal therapy using either an orchiectomy or a Gonadotropin releasing hormone (GnRH) agonist in combination with an antiandrogen must first progress through antiandrogen withdrawal prior to being eligible. The minimum timeframe to document failure of anti-androgen withdrawal will be four weeks
- Progressive castration resistant metastatic disease
- Castrate level of testosterone (<50 ng/dL), treatment to maintain castrate levels of testosterone must be continued
Who cannot join
- Has received an investigational drug in the 4 weeks before or is scheduled to receiving one during or in the 8 weeks after study drug administration.
- Has received chemo-, immuno-, or radiotherapy within the last 4 weeks prior to entry in the study, or has not recovered from acute adverse events as a result of such therapy
- Has received prior hemibody external radiotherapy
- Has a need for immediate external radiotherapy
- Has received systemic radiotherapy with radium-223, strontium-89, samarium-153, rhenium-186 or rhenium-188 for the treatment of bony metastases within the last 24 weeks prior to administration of study drug
- When receiving bisphosphonates, has changed the dose within 4 weeks before administration of study drug
Trial locations and contacts
3 sites in 1 country.
Japan3 sites
Study site
Kashiwa, Chiba, 277-8577
Study site
Sayama, Osaka, 589-8511
Study site
Yokohama, Kanagawa, 236-0004
About this study
Official title: Uncontrolled, Open-label, Non-randomized Phase I Study to Investigate Safety, Biodistribution, Radiation Dosimetry and Pharmacokinetics of a Single Dose of BAY88-8223 in Japanese Patients With Castration-resistant Prostate Cancer and Bone Metastases
This is an uncontrolled, open-label, non-randomized Phase I study to investigate safety, biodistribution, radiation dosimetry and pharmacokinetics of a single dose of BAY88-8223 in Japanese patients with castration-resistant prostate cancer and bone metastases.
- Conditions
- Prostatic Neoplasms
- Being tested
- Radium-223 dichloride (Xofigo, BAY88-8223)
- Keywords
- BAY88-8223, radium-223 dichloride, prostate cancer
- 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
Radium-223 dichloride (Xofigo, BAY88-8223) 50 kBq/kg
Radium-223 dichloride (Xofigo, BAY88-8223)Drug
Radium-223 dichloride (Xofigo, BAY88-8223) 100 kBq/kg
Radium-223 dichloride (Xofigo, BAY88-8223)Drug
Expansion arm: Radium-223 dichloride (Xofigo, BAY88-8223) 50 kBq/kg
| Study group | Role | What they receive |
|---|---|---|
| Radium-223 dichloride [50 kBq/kg] | Experimental | Not described Receives: Drug: Radium-223 dichloride (Xofigo, BAY88-8223) |
| Radium-223 dichloride [100 kBq/kg] | Experimental | Not described Receives: Drug: Radium-223 dichloride (Xofigo, BAY88-8223) |
| Radium-223 dichloride [expansion] | 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.
Number of participants with Critical toxicities
Critical toxicities (using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0) will be defined as the occurrence of one or more of the following drug-related toxicities: 1) ≥Grade 3 non-hematologic toxicity, 2) Grade 3 neutropenia with fever, 3) Grade 4 neutropenia that failed to recover to grade 2 or less after treatment with Granulocyte colony-stimulating factor (GCSF) within 2 weeks, 4) Grade 4 thrombocytopenia
Measured: Up to day 28
Maximum drug concentration in blood after single dose administration (Cmax) of BAY88-8223 for blood samples
Measured: up to 72 hours
Area under the concentration - time curve (AUC) of BAY88-8223 for blood samples
Measured: up to 72 hours
Secondary outcomes (2)
Changes in prostate specific antigen (PSA)
Measured: baseline, up to 12 weeks
Overall Survival
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionOct 2012
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 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
- NCT01565746
- Sponsor's protocol ID
- 15354
- Status last verified
- Oct 2016
- First submitted
- 1 Mar 2012
- Last updated
- 17 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Yoshida K, Kaneta T, Takano S, Sugiura M, Kawano T, Hino A, Yamamoto T, Shizukuishi K, Kaneko M, Zurth C, Inoue T. Pharmacokinetics of single dose radium-223 dichloride (BAY 88-8223) in Japanese patients with castration-resistant prostate cancer and bone metastases. Ann Nucl Med. 2016 Aug;30(7):453-60. doi: 10.1007/s12149-016-1093-8. Epub 2016 Jun 7.
PubMed 27272279Uemura H, Uemura H, Matsubara N, Kinuya S, Hosono M, Yajima Y, Doi T. Safety and efficacy of radium-223 dichloride in Japanese patients with castration-resistant prostate cancer and bone metastases. Int J Clin Oncol. 2017 Oct;22(5):954-963. doi: 10.1007/s10147-017-1130-1. Epub 2017 May 6.
PubMed 28478485
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uncontrolled, Open-label, Non-randomized Phase I Study to Investigate Safety, Biodistribution, Radiation Dosimetry and Pharmacokinetics of a Single Dose of BAY88-8223 in Japanese Patients With Castration-resistant Prostate Cancer and Bone Metastases
- ClinicalTrials.gov ID
- NCT01565746
- Acronym / sponsor ID
- 15354
- Conditions
- Prostatic Neoplasms
- Keywords
- BAY88-8223, radium-223 dichloride, prostate cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Mar 2012
- Primary completion
- Oct 2012 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 29 Mar 2012 (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.
This is an uncontrolled, open-label, non-randomized Phase I study to investigate safety, biodistribution, radiation dosimetry and pharmacokinetics of a single dose of BAY88-8223 in Japanese patients with castration-resistant prostate cancer and bone metastases.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Radium-223 dichloride [50 kBq/kg] | Experimental | Drug: Radium-223 dichloride (Xofigo, BAY88-8223) |
| Radium-223 dichloride [100 kBq/kg] | Experimental | Drug: Radium-223 dichloride (Xofigo, BAY88-8223) |
| Radium-223 dichloride [expansion] | 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 (6 listed)
- Male ≥ 20 years of age
- Histologically or cytologically confirmed adenocarcinoma of the prostate
- Presents with at least 2 bone metastases, confirmed by scintigraphic imaging within the previous 4 weeks
- Patients who has failed initial hormonal therapy using either an orchiectomy or a Gonadotropin releasing hormone (GnRH) agonist in combination with an antiandrogen must first progress through antiandrogen withdrawal prior to being eligible. The minimum timeframe to document failure of anti-androgen withdrawal will be four weeks
- Progressive castration resistant metastatic disease
Key exclusion criteria (6 listed)
- Has received an investigational drug in the 4 weeks before or is scheduled to receiving one during or in the 8 weeks after study drug administration.
- Has received chemo-, immuno-, or radiotherapy within the last 4 weeks prior to entry in the study, or has not recovered from acute adverse events as a result of such therapy
- Has received prior hemibody external radiotherapy
- Has a need for immediate external radiotherapy
- Has received systemic radiotherapy with radium-223, strontium-89, samarium-153, rhenium-186 or rhenium-188 for the treatment of bony metastases within the last 24 weeks prior to administration of study drug
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)Radium-223 dichloride (Xofigo, BAY88-8223) 50 kBq/kg | Drug | Radium-223 dichloride [50 kBq/kg] |
| Radium-223 dichloride (Xofigo, BAY88-8223)Radium-223 dichloride (Xofigo, BAY88-8223) 100 kBq/kg | Drug | Radium-223 dichloride [100 kBq/kg] |
| Radium-223 dichloride (Xofigo, BAY88-8223)Expansion arm: Radium-223 dichloride (Xofigo, BAY88-8223) 50 kBq/kg | Drug | Radium-223 dichloride [expansion] |
Primary outcome
Number of participants with Critical toxicities
Time frame: Up to day 28
Critical toxicities (using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0) will be defined as the occurrence of one or more of the following drug-related toxicities: 1) ≥Grade 3 non-hematologic toxicity, 2) Grade 3 neutropenia with fever, 3) Grade 4 neutropenia that failed to recover to grade 2 or less after treatment with Granulocyte colony-stimulating factor (GCSF) within 2 weeks, 4) Grade 4 thrombocytopenia
Maximum drug concentration in blood after single dose administration (Cmax) of BAY88-8223 for blood samples
Time frame: up to 72 hours
Area under the concentration - time curve (AUC) of BAY88-8223 for blood samples
Time frame: up to 72 hours
2 secondary outcomes
Changes in prostate specific antigen (PSA)
Time frame: baseline, up to 12 weeks
Overall Survival
Time frame: Up to 36 months
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 17 Oct 2016.
- Results publication: PubMed 27272279Yoshida K, Kaneta T, Takano S, Sugiura M, Kawano T, Hino A, Yamamoto T, Shizukuishi K, Kaneko M, Zurth C, Inoue T. Pharmacokinetics of single dose radium-223 dichloride (BAY 88-8223) in Japanese patients with castration-resistant prostate cancer and bone metastases. Ann Nucl Med. 2016 Aug;30(7):453-60. doi: 10.1007/s12149-016-1093-8. Epub 2016 Jun 7.
- Derived from this study: PubMed 28478485Uemura H, Uemura H, Matsubara N, Kinuya S, Hosono M, Yajima Y, Doi T. Safety and efficacy of radium-223 dichloride in Japanese patients with castration-resistant prostate cancer and bone metastases. Int J Clin Oncol. 2017 Oct;22(5):954-963. doi: 10.1007/s10147-017-1130-1. Epub 2017 May 6.
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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
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Radium-223 dichloride (Xofigo, BAY88-8223) in people with Prostatic Neoplasms, run by Bayer at 3 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 6 inclusion and 6 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 17 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Number of participants with Critical toxicities (time frame: Up to day 28). The study lists 3 primary outcomes in all. 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 NCT01565746, which also lists 2 linked publications.
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 17 Oct 2016.