Open-Label Access Protocol of Denosumab for Subjects With Advanced Cancer
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| ClinicalTrials.gov Identifier: NCT01419717 |
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Recruitment Status :
Completed
First Posted : August 18, 2011
Results First Posted : September 9, 2019
Last Update Posted : September 24, 2019
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Sponsor:
Amgen
Information provided by (Responsible Party):
Amgen
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Bone Metastases in Men With Hormone-Refractory Prostate Cancer Bone Metastases in Subjects With Advanced Breast Cancer | Drug: Denosumab | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 129 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Open-Label Access Protocol of Denosumab for Subjects With Advanced Cancer |
| Actual Study Start Date : | November 22, 2011 |
| Actual Primary Completion Date : | August 10, 2018 |
| Actual Study Completion Date : | August 10, 2018 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Denosumab
| Arm | Intervention/treatment |
|---|---|
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Experimental: Denosumab
Participants received 120 milligrams of denosumab injected subcutaneously every 4 weeks until denosumab was approved and available for sale.
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Drug: Denosumab
Administered by subcutaneous injection every 4 weeks (Q4W)
Other Name: Xgeva |
Primary Outcome Measures :
- Number of Participants With Adverse Events [ 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. ]
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 Outcome Measures :
- Number of Participants With 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. ]A blood sample was collected at the end of study visit for the measurement of anti-denosumab binding antibodies.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01419717
Locations
Show 64 study locations
Sponsors and Collaborators
Amgen
Investigators
| Study Director: | MD | Amgen |
Study Documents (Full-Text)
Documents provided by Amgen:
Documents provided by Amgen:
Study Protocol [PDF] February 22, 2013
Statistical Analysis Plan [PDF] August 27, 2018
Additional Information:
| Responsible Party: | Amgen |
| ClinicalTrials.gov Identifier: | NCT01419717 |
| Other Study ID Numbers: |
20110113 |
| First Posted: | August 18, 2011 Key Record Dates |
| Results First Posted: | September 9, 2019 |
| Last Update Posted: | September 24, 2019 |
| Last Verified: | September 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request |
| Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) |
| Time Frame: | Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study. |
| Access Criteria: | Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the link below. |
| URL: | https://www.amgen.com/datasharing |
Keywords provided by Amgen:
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cancer bone metastases breast cancer prostate cancer |
Additional relevant MeSH terms:
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Prostatic Neoplasms Neoplasm Metastasis Neoplasms, Second Primary Bone Neoplasms Bone Marrow Diseases Neoplasms by Site Neoplasms Genital Neoplasms, Male Urogenital Neoplasms |
Prostatic Diseases Neoplastic Processes Pathologic Processes Bone Diseases Musculoskeletal Diseases Hematologic Diseases Denosumab Bone Density Conservation Agents Physiological Effects of Drugs |