Open-Label Access Protocol of Denosumab for Subjects With Advanced Cancer
This study is enrolling participants by invitation only.
Sponsor:
Amgen
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01419717
First received: August 4, 2011
Last updated: May 30, 2013
Last verified: May 2013
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Purpose
This trial will facilitate access of denosumab for subjects with advanced cancer who have participated in a denosumab phase 3 study until denosumab is approved and available for sale, or until another mechanism is identified to provide denosumab to ongoing subjects.
| Condition | Intervention | 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 |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Open-Label Access Protocol of Denosumab for Subjects With Advanced Cancer |
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:
- Subject incidence of treatment-emergent adverse events [ Time Frame: Study duration (expected to be approximately 1 year per subject) ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Subject incidence of anti-denosumab antibodies [ Time Frame: Study duration (expected to be approximately 1 year per subject) ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 400 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: denosumab
120 milligrams of denosumab injected subcutaneously every 4 weeks
|
Drug: denosumab
120 milligrams of denosumab injected subcutaneously every 4 weeks until denosumab is approved and available for sale (expected to be approximately 1 year of treatment per subject)
Other Name: Xgeva
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01419717
Show 67 Study Locations
Show 67 Study LocationsSponsors and Collaborators
Amgen
Investigators
| Study Director: | MD | Amgen |
More Information
Additional Information:
No publications provided
| Responsible Party: | Amgen |
| ClinicalTrials.gov Identifier: | NCT01419717 History of Changes |
| Other Study ID Numbers: | 20110113 |
| Study First Received: | August 4, 2011 |
| Last Updated: | May 30, 2013 |
| Health Authority: | Australia: Therapeutic Goods Administration Brazil: ANVISA (Agência Nacional de Vigilância Sanitária) Brazil: Ministry of Health Chile: Health Ministry European Union: European Medicines Agency India: Central India Medical Research Ethics Committee Israel: Ministry of Health Panama: Ministry of Health Peru: Dirección General de Medicamentos, Insumos y Drogas (DIGEMID) Peru: INS (Instituto Nacional de Salud) Peru: Ministry of Health Russia: National Ethic Committee South Africa: Medicines Control Council Ukraine: Pharmacological Centre at the Ministry of Health of the Ukraine (Pharma Centre) United Kingdom: Medicines and Healthcare Products Regulatory Agency Argentina: ANMAT (Administracion Nacional de Medicamentos Alimentos y Tecnologia Medica) Argentina: Ministry of Health |
Keywords provided by Amgen:
|
cancer bone metastases breast cancer prostate cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasm Metastasis Neoplasms, Second Primary Prostatic Neoplasms Bone Neoplasms Bone Marrow Diseases Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
Neoplastic Processes Pathologic Processes Genital Neoplasms, Male Urogenital Neoplasms Genital Diseases, Male Prostatic Diseases Bone Diseases Musculoskeletal Diseases Hematologic Diseases |
ClinicalTrials.gov processed this record on June 18, 2013