Open Label Extension to SRE Studies in United Kingdom and Czech Republic Only

An Open Label, Single Arm, Extension Study to Evaluate the Long Term Safety of Denosumab in the Treatment of Bone Metastases in Subjects with Advanced Cancer or Multiple Myeloma

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-009374-27-GB

Enrollment

Registered

2009-05-08

Start date

2009-08-27

Completion date

Unknown

Last updated

2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone metastases in subjects with advanced cancer or multiple myeloma 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)

Interventions

Trade Name: XGEVA Product Name: Denosumab Product Code: AMG 162 Pharmaceutical Form: Solution for injection INN or Proposed INN: Denosum

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Subjects currently enrolled in study 20050103, 20050136, or 20050244 Subjects must sign the informed consent before any study specific procedures are performed 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 16 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 19

Exclusion criteria

Exclusion criteria: Developed sensitivity to mammalian cell derived drug products during the 20050103, 20050136, or 20050244 study Currently receiving any unapproved investigational product other than denosumab Subject is pregnant or breast feeding, or planning to become pregnant within 7 months after the end of treatment Subject (male or female) is not willing to use 2 highly effective contraception during treatment and for 7 months (women) or 10 months (men) after the end of treatment Male subject with a pregnant partner who is not willing to use a condom during treatment and for additional 10 months after the end of treatment Any disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or comply with study procedures

Design outcomes

Primary

Measure	Time frame
Main Objective: To describe the safety and tolerability of denosumab administration as measured by adverse events, immunogenicity, and safety laboratory parameters in subjects who previously received either zoledronic acid (Zometa®) or denosumab.;Secondary Objective: Not applicable;Timepoint(s) of evaluation of this end point: 2 Years; Primary end point(s): • Subject incidence of treatment-emergent adverse events • Changes in laboratory values • Incidence of anti-denosumab antibody (binding and neutralizing) formation • Brief Pain Inventory – Short Form “worst” pain score	—

Measure

Time frame

Main Objective: To describe the safety and tolerability of denosumab administration as measured by adverse events, immunogenicity, and safety laboratory parameters in subjects who previously received either zoledronic acid (Zometa®) or denosumab.;Secondary Objective: Not applicable;Timepoint(s) of evaluation of this end point: 2 Years; Primary end point(s): • Subject incidence of treatment-emergent adverse events • Changes in laboratory values • Incidence of anti-denosumab antibody (binding and neutralizing) formation • Brief Pain Inventory – Short Form “worst” pain score

—

Secondary

Measure	Time frame
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable	—

Countries

Czech Republic, United Kingdom

Contacts

Public ContactIHQ Medical Info – Clinical Trials

Amgen (EUROPE) GmbH

MedinfoInternational@amgen.comNANANANA

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026