Bone Metastases in Men With Hormone-Refractory Prostate Cancer, Bone Metastases in Subjects With Advanced Breast Cancer
Conditions
Keywords
cancer, bone metastases, breast cancer, prostate cancer
Brief 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.
Interventions
DRUGDenosumab
Administered by subcutaneous injection every 4 weeks (Q4W)
Sponsors
Amgen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Anti-denosumab Binding Antibodies | Assessed at end of study; the median (minimum, maximum) time on study for all enrolled participants was 13.9 (0.0, 74.7) months. | A blood sample was collected at the end of study visit for the measurement of anti-denosumab binding antibodies. |
Countries
Argentina, Austria, Belgium, Brazil, Czechia, France, Hungary, Israel, Italy, Japan, Latvia, Lithuania, Panama, Peru, Poland, Russia, South Africa, Spain, Ukraine
Participant flow
Recruitment details
This study was conducted at 65 centers in Europe, Latin America, Japan, and South Africa. Participants were enrolled from 22 November 2011 to 27 October 2014.
Participants by arm
| Arm | Count |
|---|---|
| Denosumab Participants were offered 120 milligrams of denosumab injected subcutaneously every 4 weeks until denosumab was approved and available for sale. | 129 |
| Total | 129 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Administrative Decision | 1 |
| Overall Study | Adverse Event | 19 |
| Overall Study | Death | 17 |
| Overall Study | Disease Progression | 9 |
| Overall Study | Lost to Follow-up | 2 |
| Overall Study | Noncompliance | 1 |
| Overall Study | Other | 4 |
| Overall Study | Protocol-specified Criteria | 62 |
| Overall Study | Withdrawal by Subject | 10 |
Baseline characteristics
| Characteristic | Denosumab |
|---|---|
| Age, Continuous | 65.74 years STANDARD_DEVIATION 11.48 |
| Age, Customized 18 - 64 years | 60 Participants |
| Age, Customized 65 - 74 years | 36 Participants |
| Age, Customized 75 - 84 years | 28 Participants |
| Age, Customized ≥ 85 years | 5 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 28 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 101 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race/Ethnicity, Customized Asian | 15 Participants |
| Race/Ethnicity, Customized Black or African American | 6 Participants |
| Race/Ethnicity, Customized Other | 4 Participants |
| Race/Ethnicity, Customized Unknown | 1 Participants |
| Race/Ethnicity, Customized White | 103 Participants |
| Sex: Female, Male Female | 97 Participants |
| Sex: Female, Male Male | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 18 / 128 |
| other Total, other adverse events | 66 / 128 |
| serious Total, serious adverse events | 45 / 128 |
Outcome results
Primary
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.
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.
Population: All participants who received at least one dose of denosumab in study 20110113
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Denosumab | Number of Participants With Adverse Events | All adverse events | 98 Participants |
| Denosumab | Number of Participants With Adverse Events | Serious adverse events | 45 Participants |
| Denosumab | Number of Participants With Adverse Events | AE leading to discontinuation of denosumab | 28 Participants |
| Denosumab | Number of Participants With Adverse Events | AE leading to discontinuation from study | 22 Participants |
| Denosumab | Number of Participants With Adverse Events | Fatal adverse events | 18 Participants |
| Denosumab | Number of Participants With Adverse Events | AE grade 3, 4, or 5 | 46 Participants |
| Denosumab | Number of Participants With Adverse Events | Treatment-related adverse event | 26 Participants |
| Denosumab | Number of Participants With Adverse Events | Treatment-related serious adverse event | 10 Participants |
| Denosumab | Number of Participants With Adverse Events | TRAE leading to discontinuation of denosumab | 18 Participants |
| Denosumab | Number of Participants With Adverse Events | TRAE leading to discontinuation from study | 16 Participants |
| Denosumab | Number of Participants With Adverse Events | Treatment-related fatal adverse events | 0 Participants |
| Denosumab | Number of Participants With Adverse Events | Treatment-related AE grade 3, 4, or 5 | 8 Participants |
Secondary
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.
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.
Population: Participants who received at least 1 dose of denosumab in study 20110113 and with at least 1 antibody sample tested.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Denosumab | Number of Participants With Anti-denosumab Binding Antibodies | 0 Participants |