Open-Label Access Protocol of Denosumab for Subjects With Advanced Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Open-Label Access Protocol of Denosumab for Subjects With Advanced Cancer

Conditions
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Bone Metastases in Men With Hormone-Refractory Prostate Cancer, Bone Metastases in Subjects With Advanced Breast Cancer

Intervention / Treatment
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* Drug: Denosumab


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Denosumab<br>Participants received 120 milligrams of denosumab injected subcutaneously every 4 weeks until denosumab was approved and available for sale. | Drug: Denosumab<br>* Administered by subcutaneous injection every 4 weeks (Q4W)<br>* Other names: Xgeva;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Assessed at end of study; the median (minimum, maximum) time on study for all enrolled participants was 13.9 (0.0, 74.7) months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cancer, bone metastases, breast cancer, prostate cancer