Bone Metastases in Men With Hormone-Refractory Prostate Cancer, Bone Metastases in Subjects With Advanced Breast Cancer, Bone Metastases in Subjects With Advanced Cancer or Multiple Myeloma
Conditions
Keywords
Bone metastases, Hormone-refractory prostate cancer, Multiple myeloma, Denosumab, Breast cancer, 20050103, 20050136, 20050244, Advanced cancer, Tumor, Prostate cancer, Zoledronic acid
Brief summary
The purpose of this study is to describe the safety and tolerability of denosumab administration as measured by adverse events, immunogenicity, and safety laboratory parameters in subjects who previously received either zoledronic acid (Zometa®) or denosumab.
Interventions
DRUGamg 162
120 mg SC injection of denosumab Q4W until the subject has access to commercially available product or for up to 2 years, which ever comes first.
Sponsors
Amgen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects currently enrolled in study 20050103, 20050136, or 20050244 * Subjects must sign the informed consent before any study specific procedures are performed
Exclusion criteria
* Developed sensitivity to mammalian cell derived drug products during the 20050103, 20050136, or 20050244 study * Currently receiving any unapproved investigational product other than denosumab * Subject is pregnant or breast feeding, or planning to become pregnant within 7 months after the end of treatment * Subject (male or female) is not willing to use 2 highly effective contraception during treatment and for 7 months (women) or 10 months (men) after the end of treatment * Male subject with a pregnant partner who is not willing to use a condom during treatment and for additional 10 months after the end of treatment * Any disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or comply with study procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Participants Survived | 2 years |
Countries
Czechia, United Kingdom
Participant flow
Recruitment details
Subjects recuited in this open-label extension study were those who were enrolled in the 2 parent (phase 3, randomized, double-blind, active-controlled) studies 20050103 (NCT00321620) or 20050136 (NCT00321464) at sites in the Czech Republic and United Kingdom.
Participants by arm
| Arm | Count |
|---|---|
| Zoledronic Acid 4 mg Q4W / Denosumab 120 mg Q4W This cohort received Zoledronic Acid 4 mg Q4W in the blinded treatment phase of the parent study 20050103 (NCT00321620) or 20050136 (NCT00321464), and received Denosumab 120 mg Q4W in this open-label extension study. | 17 |
| Denosumab 120 mg Q4W / Denosumab 120 mg Q4W This cohort received Denosumab 120 mg Q4W in the blinded treatment phase of the parent study 20050103 (NCT00321620) or 20050136 (NCT00321464), and received Denosumab 120 mg Q4W in this open-label extension study. | 18 |
| Total | 35 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Administrative decision | 3 | 1 |
| Overall Study | Adverse Event | 0 | 2 |
| Overall Study | Consent withdrawn | 1 | 3 |
| Overall Study | Death | 4 | 6 |
| Overall Study | Disease progression | 2 | 2 |
| Overall Study | Ineligibility determined | 1 | 0 |
| Overall Study | Noncompliance | 1 | 0 |
| Overall Study | Poor performance status | 0 | 1 |
Baseline characteristics
| Characteristic | Zoledronic Acid 4 mg Q4W / Denosumab 120 mg Q4W | Total | Denosumab 120 mg Q4W / Denosumab 120 mg Q4W |
|---|---|---|---|
| Age, Continuous | 61.6 Years STANDARD_DEVIATION 11.1 | 61.3 Years STANDARD_DEVIATION 11.9 | 61.1 Years STANDARD_DEVIATION 13 |
| Race/Ethnicity, Customized Black or African American | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White or Caucasian | 17 Participants | 34 Participants | 17 Participants |
| Sex: Female, Male Female | 7 Participants | 13 Participants | 6 Participants |
| Sex: Female, Male Male | 10 Participants | 22 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 13 / 17 | 13 / 18 |
| serious Total, serious adverse events | 8 / 17 | 10 / 18 |
Outcome results
Primary
Number of Participants Survived
Time frame: 2 years
Population: Full Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Zoledronic Acid 4 mg Q4W / Denosumab 120 mg Q4W | Number of Participants Survived | 13 Participants |
| Denosumab 120 mg Q4W / Denosumab 120 mg Q4W | Number of Participants Survived | 12 Participants |