Open-Label Access Protocol of Denosumab for Subjects With Advanced Cancer
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
First received: August 4, 2011
Last updated: January 28, 2015
Last verified: January 2015
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 ]
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||June 2017 (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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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
||January 28, 2015
||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 March 26, 2015
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms by Site