Open Label Extension to SRE Studies in United Kingdom and Czech Republic Only
This study is ongoing, but not recruiting participants.
Sponsor:
Amgen
Information provided by:
Amgen
ClinicalTrials.gov Identifier:
NCT00950911
First received: July 30, 2009
Last updated: September 29, 2011
Last verified: September 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
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 |
Drug: amg 162 |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | An Open Label, Single Arm, Extension Study to Evaluate the Long Term Safety of Denosumab in the Treatment of Bone Metastases in Subjects With Advanced Cancer or Multiple Myeloma |
Resource links provided by NLM:
Genetics Home Reference related topics:
breast cancer
Drug Information available for:
Denosumab
U.S. FDA Resources
Further study details as provided by Amgen:
Primary Outcome Measures:
- 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. [ Time Frame: Two years ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 100 |
| Study Start Date: | July 2009 |
| Estimated Study Completion Date: | February 2012 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: amg 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.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00950911
Locations
| Czech Republic | |
| Research Site | |
| Jindrichuv Hradec, Czech Republic | |
| Research Site | |
| Kromeriz, Czech Republic | |
| Research Site | |
| Olomouc, Czech Republic | |
| Research Site | |
| Praha 1, Czech Republic | |
| Research Site | |
| Praha 4, Czech Republic | |
| Research Site | |
| Praha 5, Czech Republic | |
| Research Site | |
| Praha 6, Czech Republic | |
| Research Site | |
| Zlin, Czech Republic | |
| United Kingdom | |
| Research Site | |
| Leeds, United Kingdom | |
| Research Site | |
| London, United Kingdom | |
| Research Site | |
| Manchester, United Kingdom | |
| Research Site | |
| Northwood, United Kingdom | |
| Research Site | |
| Peterborough, United Kingdom | |
| Research Site | |
| West Sussex, United Kingdom | |
| Research Site | |
| York, United Kingdom | |
Sponsors and Collaborators
Amgen
Investigators
| Study Director: | MD | Amgen |
More Information
Additional Information:
No publications provided
| Responsible Party: | Global Development Leader, Amgen Inc. |
| ClinicalTrials.gov Identifier: | NCT00950911 History of Changes |
| Other Study ID Numbers: | 20080540 |
| Study First Received: | July 30, 2009 |
| Last Updated: | September 29, 2011 |
| Health Authority: | Czech Republic: Statni ustav pro kontrolu leciv United Kingdom: Main Research Ethics Committee United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by Amgen:
|
Bone metastases Hormone-refractory prostate cancer Multiple myeloma Denosumab Breast cancer 20050103 |
20050136 20050244 Advanced cancer Tumor Prostate cancer Zoledronic acid |
Additional relevant MeSH terms:
|
Breast Neoplasms Multiple Myeloma Neoplasms, Plasma Cell Neoplasm Metastasis Neoplasms, Second Primary Prostatic Neoplasms Bone Neoplasms Bone Marrow Diseases Neoplasms Neoplasms by Site Breast Diseases Skin Diseases Neoplasms by Histologic Type Hemostatic Disorders Vascular Diseases |
Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders Lymphoproliferative Disorders Immunoproliferative Disorders Immune System Diseases Neoplastic Processes Pathologic Processes Genital Neoplasms, Male Urogenital Neoplasms Genital Diseases, Male Prostatic Diseases Bone Diseases |
ClinicalTrials.gov processed this record on June 18, 2013