Open-Label Access Protocol of Denosumab for Subjects With Advanced Cancer

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Amgen
ClinicalTrials.gov Identifier:
NCT01419717
First received: August 4, 2011
Last updated: April 9, 2014
Last verified: April 2014
  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:


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 64 Study Locations
Sponsors 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: April 9, 2014
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 April 17, 2014