Phase 3
Completed N=129
Open-Label Access Protocol of Denosumab for Subjects With Advanced Cancer
Bone Metastases in Men With Hormone-Refractory Prostate Cancer · Bone Metastases in Subjects With Advanced Breast Cancer
Source: ClinicalTrials.gov NCT01419717 ↗
Enrolled (actual)
129
Serious AEs
35.2%
Results posted
Sep 2019
Primary outcomePrimary: Number of Participants With Adverse Events — 98; 45; 28; 22 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events |
98; 45; 28; 22; 18; 46 | — |
| SECONDARY Number of Participants With Anti-denosumab Binding Antibodies |
— | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01419717). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.