Clinical trial · Interventional
Open-Label Access Protocol of Denosumab for Subjects With Advanced Cancer
NCT01419717CI-TRIAL-00040800completedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bone Metastases in Men With Hormone-Refractory Prostate Cancer | — | UNRESOLVED | — |
| Bone Metastases in Subjects With Advanced Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Denosumab | Drug | Denosumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Denosumab
- description
- Participants received 120 milligrams of denosumab injected subcutaneously every 4 weeks until denosumab was approved and available for sale.
- interventionNames
- Drug: Denosumab
Primary outcomes (1)
- measure
- Number of Participants With Adverse Events
- timeFrame
- 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.
- description
- 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 outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.