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: 14.0 Level: LLT Classification code 10062904 Term: Hormone-refractory prostate cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.0 Level: LLT Classification code 10027475 Term: Metastatic breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 14.0 Level: LLT Classification code 10005993 Term: Bone metastases System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-09-21
• Study Completion: 2018-08-10
• Last Update Posted: 30 April 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 198
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 202

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