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

Phase 1

• Conditions: Bone Metastases in Subjects with Advanced Breast Cancer and Bone Metastases in Men with Hormone-Refractory Prostate Cancer; MedDRA version: 14.1 Level: LLT Classification code 10027475 Term: Metastatic breast cancer System Organ Class: 100000004864; MedDRA version: 14.1 Level: LLT Classification code 10005993 Term: Bone metastases System Organ Class: 100000004864; MedDRA version: 14.1 Level: LLT Classification code 10062904 Term: Hormone-refractory prostate cancer System Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2011-002114-36-BE
• Lead Sponsor: Amgen Inc

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-10-07
• Study Completion: 2018-08-10
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 129

Inclusion Criteria

- Subjects 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 84
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 84

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 method 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Main Objective: To facilitate the 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<br> <br> Safety Objective: To further assess the safety of denosumab for subjects who have participated in open label extensions of a denosumab advanced cancer phase 3 study<br> ;Secondary Objective: Not applicable;Primary end point(s): Subject incidence of treatment-emergent adverse events and anti-denosumab antibodies;Timepoint(s) of evaluation of this end point: End of study (i.e. the time when the last subject is assessed or receives an intervention for evaluation in the study)

Secondary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: Not applicable;Secondary end point(s): Not applicable