NeoplasmsNCT02331303
A Drug Utilization Study of Radium-223 in Sweden
An observational study of Neoplasms, run by Bayer at 1 site in Sweden.
Trial summary
The objective of this study is to evaluate the extent of potential off-label use of Xofigo in Sweden. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Neoplasms
- What is being tested?
- Radium-223 dichloride (Xofigo, BAY88-8223)
- How many people
- 37 participants
- Where
- 1 siteSweden
- Study dates
- 15 Apr 2015to 19 Dec 2017
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This study will include patients receiving treatment of Xofigo at certified nuclear medicine centers across Sweden during a two year period. It will consist of mCRPC patients and potentially some other patient groups in whom Xofigo may be used off-label including women, children, cancer patients having bone metastasis with a diagnosis other than CRPC, and patients with repeated courses of treatment or in excess of those recommended in the label. This study will be based on data extracted from two pre-established data sources: 15 nuclear medicine centers across Sweden and the Swedish National Cancer Registry.
Who may be able to join
- Patients receiving Xofigo with data recorded at nuclear medicine centers in Sweden between 01 July 2014 and 30 June 2016 will be included in the study
Who cannot join
- Patients receiving Xofigo in a clinical trial will not be included in this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Drug Utilization Study of Xofigo Use in Sweden
The objective of this study is to evaluate the extent of potential off-label use of Xofigo in Sweden.
- Conditions
- Neoplasms
- Being tested
- Radium-223 dichloride (Xofigo, BAY88-8223)
- Medical subject headings
- 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)Other
Xofigo was approved in the US and EU for the following indication: Xofigo is indicated for the treatment of adults with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastases. Xofigo is contraindicated in women who are or may become pregnant.
| Study group | Role | What they receive |
|---|---|---|
| Group1 | This is a single-arm descriptive observational drug utilization study based on secondary data collection of patients treated with Xofigo in Sweden.
This study will include patients receiving treatment of Xofigo at certified nuclear medicine centers across Sweden during a two year period. Receives: Other: Radium-223 dichloride (Xofigo, BAY88-8223) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of men with metastatic castration resistant prostate cancer (mCRPC) of Xofigo use
Measured: Up to 2 years
Proportion of being women of Xofigo use
Measured: Up to 2 years
Proportion of being children of Xofigo use
Measured: Up to 2 years
Proportion of bone metastasis but having a diagnosis of other cancer than mCRPV
Measured: Up to 2 years
Dosage of Xofigo (kBq/kg)
Measured: Up to 2 years
Proportion of participants of dose outside label recommendation
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2015 (estimated)
- Study start15 Apr 2015
- Primary completion19 Dec 2017
- Study completion19 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 37 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
- NCT02331303
- Sponsor's protocol ID
- 17399
- Status last verified
- Jan 2018
- First submitted
- 2 Jan 2015
- Last updated
- 23 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Drug Utilization Study of Xofigo Use in Sweden
- ClinicalTrials.gov ID
- NCT02331303
- Acronym / sponsor ID
- 17399
- Conditions
- Neoplasms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 15 Apr 2015 (actual)
- Primary completion
- 19 Dec 2017 (actual)
- Study completion
- 19 Dec 2017 (actual)
- First posted
- 6 Jan 2015 (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.
The objective of this study is to evaluate the extent of potential off-label use of Xofigo in Sweden.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group1 | – | Other: Radium-223 dichloride (Xofigo, BAY88-8223)This is a single-arm descriptive observational drug utilization study based on secondary data collection of patients treated with Xofigo in Sweden. This study will include patients receiving treatment of Xofigo at certified nuclear medicine centers across Sweden during a two year period. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study will include patients receiving treatment of Xofigo at certified nuclear medicine centers across Sweden during a two year period. It will consist of mCRPC patients and potentially some other patient groups in whom Xofigo may be used off-label including women, children, cancer patients having bone metastasis with a diagnosis other than CRPC, and patients with repeated courses of treatment or in excess of those recommended in the label. This study will be based on data extracted from two pre-established data sources: 15 nuclear medicine centers across Sweden and the Swedish National Cancer Registry.
Key inclusion criteria (1 listed)
- Patients receiving Xofigo with data recorded at nuclear medicine centers in Sweden between 01 July 2014 and 30 June 2016 will be included in the study
Key exclusion criteria (1 listed)
- Patients receiving Xofigo in a clinical trial will not be included in this study
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)Xofigo was approved in the US and EU for the following indication: Xofigo is indicated for the treatment of adults with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastases. Xofigo is contraindicated in women who are or may become pregnant. | Other | Group1 |
Primary outcome
Proportion of men with metastatic castration resistant prostate cancer (mCRPC) of Xofigo use
Time frame: Up to 2 years
Proportion of being women of Xofigo use
Time frame: Up to 2 years
Proportion of being children of Xofigo use
Time frame: Up to 2 years
Proportion of bone metastasis but having a diagnosis of other cancer than mCRPV
Time frame: Up to 2 years
Dosage of Xofigo (kBq/kg)
Time frame: Up to 2 years
Proportion of participants of dose outside label recommendation
Time frame: Up to 2 years
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 23 Jan 2018.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neoplasms, run by Bayer at 1 site in Sweden.
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 1 inclusion and 1 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 23 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. 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.
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?
Proportion of men with metastatic castration resistant prostate cancer (mCRPC) of Xofigo use (time frame: Up to 2 years). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jan 2018.