Open-Label Access Protocol of Denosumab for Subjects With Advanced Cancer
This study is enrolling participants by invitation only.
Information provided by (Responsible Party):
First received: August 4, 2011
Last updated: October 23, 2013
Last verified: October 2013
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.
Bone Metastases in Men With Hormone-Refractory Prostate Cancer
Bone Metastases in Subjects With Advanced Breast Cancer
||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Open-Label Access Protocol of Denosumab for Subjects With Advanced Cancer
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:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2014 (Final data collection date for primary outcome measure)
120 milligrams of denosumab injected subcutaneously every 4 weeks
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
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01419717
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||August 4, 2011
||October 23, 2013
||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:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 11, 2013
Neoplasms, Second Primary
Bone Marrow Diseases
Neoplasms by Site
Genital Neoplasms, Male
Genital Diseases, Male