Bone Metastases in Men With Hormone-Refractory Prostate CancerPhase 3NCT01419717
Open-Label Access Protocol of Denosumab for Subjects With Advanced Cancer
A Phase 3 study testing Denosumab in people with Bone Metastases in Men With Hormone-Refractory Prostate Cancer and Bone Metastases in Subjects With Advanced Breast Cancer, run by Amgen at 64 sites in 19 countries.
Trial summary
This trial will facilitate access to denosumab for adults with advanced cancer who have participated in a denosumab phase 3 study until denosumab is approved and available for sale. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Metastases in Men With Hormone-Refractory Prostate Cancer, Bone Metastases in Subjects With Advanced Breast Cancer
- What is being tested?
- Denosumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 64 sitesin 19 countries
- Study dates
- 22 Nov 2011to 10 Aug 2018
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject was previously enrolled in a denosumab phase 3 study and participated in the Open-label Extension portion of that study.
- Subject or subject's legally acceptable representative has provided informed consent.
Who cannot join
- Subject is of child bearing potential and planning to become pregnant within 7 months after the end of treatment.
- Subject is of child bearing potential and is not willing to use, in combination with her partner, two highly effective methods of contraception during treatment and for 7 months after the end of treatment.
- Subject has known sensitivity to any of the products to be administered during dosing.
- Subject will not be available for protocol required study visits or procedures, to the best of the subject and investigator's knowledge.
- Subject has any kind of disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or to comply with all required study procedures.
Trial locations and contacts
64 sites in 19 countries.
64 sites in 19 countries
Brazil10 sites
Research Site
Porto Alegre, Rio Grande do Sul, 90035-003
Research Site
Porto Alegre, Rio Grande do Sul, 90610-000
Research Site
Rio de Janeiro, 20551-030
Research Site
Rio de Janeiro, 22640-000
Research Site
Santo André, São Paulo, 09060-650
Research Site
São Paulo, São Paulo, 01221-020
Research Site
São Paulo, São Paulo, 01509-900
Research Site
São Paulo, São Paulo, 04262-000
Research Site
São Paulo, 01209-000
Research Site
Sorocaba, São Paulo, 18030-200
Japan7 sites
Research Site
Chuo-ku, Tokyo, 104-0045
Research Site
Isehara-shi, Kanagawa, 259-1193
Research Site
Kagoshima, Kagoshima-ken, 892-0833
Research Site
Kitaadachi-gun, Saitama, 362-0806
Research Site
Kure-shi, Hiroshima, 737-0023
Research Site
Osaka, Osaka, 540-0006
Research Site
Tokyo, 135-8550
Russia7 sites
Research Site
Arkhangelsk, 163045
Research Site
Chelyabinsk, 454087
Research Site
Krasnogorsky District, 143423
Research Site
Moscow, 115478
Research Site
Obninsk, 249036
Research Site
Omsk, 644013
Research Site
Saint Petersburg, 197089
Czechia6 sites
Research Site
Kroměříž, 767 55
Research Site
Olomouc, 775 20
Research Site
Prague, 110 00
Research Site
Prague, 140 00
Research Site
Prague, 140 44
Research Site
Prague, 150 06
Poland6 sites
Research Site
Bialystok, 15-027
Research Site
Bydgoszcz, 85-171
Research Site
Gdansk, 80-952
Research Site
Lublin, 20-954
Research Site
Poznan, 61-866
Research Site
Warsaw, 00-631
Argentina4 sites
Research Site
Capital Federal, Buenos Aires, C1426ANZ
Research Site
Córdoba, Córdoba Province, X5016KEH
Research Site
Quilmes, Buenos Aires, B1878GEG
Research Site
Rosario, Santa Fe Province, S2000PBJ
Israel4 sites
Research Site
Haifa, 31096
Research Site
Rehovot, 76100
Research Site
Tel Aviv, 64239
Research Site
Tsrifin, 70300
Spain4 sites
Research Site
Madrid, 28034
Research Site
Madrid, 28040
Research Site
Seville, Andalusia, 41013
Research Site
Valencia, Valencia, 46009
About this study
This trial will facilitate access to denosumab for adults with advanced cancer who have participated in a denosumab phase 3 study until denosumab is approved and available for sale.
- Conditions
- Bone Metastases in Men With Hormone-Refractory Prostate Cancer, Bone Metastases in Subjects With Advanced Breast Cancer
- Being tested
- Denosumab
- Keywords
- cancer, bone metastases, breast cancer, prostate cancer
- Medical subject headings
- Neoplasms, Breast Neoplasms, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DenosumabDrug
Also called Xgeva
Administered by subcutaneous injection every 4 weeks (Q4W)
| Study group | Role | What they receive |
|---|---|---|
| Denosumab | Experimental | Participants received 120 milligrams of denosumab injected subcutaneously every 4 weeks until denosumab was approved and available for sale. Receives: Drug: Denosumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events
An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant. The event does not necessarily have a causal relationship with study treatment.
Each AE was graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, where Grade 1 = Mild AE Grade 2 = Moderate AE Grade 3 = Severe AE Grade 4 = Life-threatening or disabling AE Grade 5 = Death related to AE. Treatment-related adverse events (TRAEs) includes events for which the investigator indicated there was a reasonable possibility they may have been caused by investigational product.
Measured: From first dose of denosumab in Study 20110113 to end of study; median (minimum, maximum) time on study was 13.93 (0.0, 74.7) months.
Secondary outcomes (1)
Number of Participants With Anti-denosumab Binding Antibodies
A blood sample was collected at the end of study visit for the measurement of anti-denosumab binding antibodies.
Measured: Assessed at end of study; the median (minimum, maximum) time on study for all enrolled participants was 13.9 (0.0, 74.7) months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2011 (estimated)
- Study start22 Nov 2011
- Primary completion10 Aug 2018
- Study completion10 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bone Metastases in Men With Hormone-Refractory Prostate CancerStudies of the same condition, open and under way.
- More trials run by AmgenThe 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01419717
- Sponsor's protocol ID
- 20110113
- Status last verified
- Sep 2019
- First submitted
- 4 Aug 2011
- Last updated
- 24 Sep 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label Access Protocol of Denosumab for Subjects With Advanced Cancer
- ClinicalTrials.gov ID
- NCT01419717
- Acronym / sponsor ID
- 20110113
- Conditions
- Bone Metastases in Men With Hormone-Refractory Prostate Cancer, Bone Metastases in Subjects With Advanced Breast Cancer
- Keywords
- cancer, bone metastases, breast cancer, prostate cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 22 Nov 2011 (actual)
- Primary completion
- 10 Aug 2018 (actual)
- Study completion
- 10 Aug 2018 (actual)
- First posted
- 18 Aug 2011 (estimated)
- Results
- Posted 9 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial will facilitate access to denosumab for adults with advanced cancer who have participated in a denosumab phase 3 study until denosumab is approved and available for sale.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Denosumab | Experimental | Drug: DenosumabParticipants received 120 milligrams of denosumab injected subcutaneously every 4 weeks until denosumab was approved and available for sale. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject was previously enrolled in a denosumab phase 3 study and participated in the Open-label Extension portion of that study.
- Subject or subject's legally acceptable representative has provided informed consent.
Key exclusion criteria (5 listed)
- Subject is of child bearing potential and planning to become pregnant within 7 months after the end of treatment.
- Subject is of child bearing potential and is not willing to use, in combination with her partner, two highly effective methods of contraception during treatment and for 7 months after the end of treatment.
- Subject has known sensitivity to any of the products to be administered during dosing.
- Subject will not be available for protocol required study visits or procedures, to the best of the subject and investigator's knowledge.
- Subject has any kind of disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or to comply with all required study procedures.
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 |
|---|---|---|
| DenosumabAlso: XgevaAdministered by subcutaneous injection every 4 weeks (Q4W) | Drug | Denosumab |
Primary outcome
Number of Participants With Adverse Events
Time frame: From first dose of denosumab in Study 20110113 to end of study; median (minimum, maximum) time on study was 13.93 (0.0, 74.7) months.
An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant. The event does not necessarily have a causal relationship with study treatment. Each AE was graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, where Grade 1 = Mild AE Grade 2 = Moderate AE Grade 3 = Severe AE Grade 4 = Life-threatening or disabling AE Grade 5 = Death related to AE. Treatment-related adverse events (TRAEs) includes events for which the investigator indicated there was a reasonable possibility they may have been caused by investigational product.
1 secondary outcome
Number of Participants With Anti-denosumab Binding Antibodies
Time frame: Assessed at end of study; the median (minimum, maximum) time on study for all enrolled participants was 13.9 (0.0, 74.7) months.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
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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.
MD study director
Amgen
64 sites in 19 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Denosumab in people with Bone Metastases in Men With Hormone-Refractory Prostate Cancer and Bone Metastases in Subjects With Advanced Breast Cancer, run by Amgen at 64 sites in 19 countries.
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 2 inclusion and 5 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 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 64 sites in Brazil, Japan, Russia, Czechia, Poland and 14 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Adverse Events (time frame: From first dose of denosumab in Study 20110113 to end of study; median (minimum, maximum) time on study was 13.93 (0.0, 74.7) months.). 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 24 Sep 2019.