NCT00950911

Brief Summary

The purpose of this study is 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jul 2009

Typical duration for phase_3

Geographic Reach
2 countries

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

July 30, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 3, 2009

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

February 11, 2014

Completed
Last Updated

February 11, 2014

Status Verified

December 1, 2013

Enrollment Period

2.6 years

First QC Date

July 30, 2009

Results QC Date

December 17, 2012

Last Update Submit

December 19, 2013

Conditions

Bone Metastases in Men With Hormone-Refractory Prostate CancerBone Metastases in Subjects With Advanced Breast CancerBone Metastases in Subjects With Advanced Cancer or Multiple Myeloma

Keywords

Bone metastasesHormone-refractory prostate cancerMultiple myelomaDenosumabBreast cancer200501032005013620050244Advanced cancerTumorProstate cancerZoledronic acid

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Survived

    2 years

Study Arms (1)

1

EXPERIMENTAL
Drug: amg 162

Interventions

amg 162DRUG

120 mg SC injection of denosumab Q4W until the subject has access to commercially available product or for up to 2 years, which ever comes first.

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects currently enrolled in study 20050103, 20050136, or 20050244
  • Subjects must sign the informed consent before any study specific procedures are performed

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Research Site

Jindřichův Hradec, 377 01, Czechia

Location

Research Site

Kroměříž, 767 55, Czechia

Location

Research Site

Olomouc, 775 20, Czechia

Location

Research Site

Prague, 110 00, Czechia

Location

Research Site

Prague, 140 00, Czechia

Location

Research Site

Prague, 140 44, Czechia

Location

Research Site

Prague, 150 06, Czechia

Location

Research Site

Prague, 160 00, Czechia

Location

Research Site

Zlín, 762 75, Czechia

Location

Research Site

Chichester, PO19 4SE, United Kingdom

Location

Research Site

Leeds, LS9 7TF, United Kingdom

Location

Research Site

London, SE1 9RT, United Kingdom

Location

Research Site

London, W2 1NY, United Kingdom

Location

Research Site

Manchester, M20 4BX, United Kingdom

Location

Research Site

Northwood, HA6 2RN, United Kingdom

Location

Research Site

Peterborough, PE3 9GZ, United Kingdom

Location

Research Site

York, YO31 8HE, United Kingdom

Location

Related Links

MeSH Terms

Conditions

Multiple MyelomaBreast NeoplasmsNeoplasmsProstatic Neoplasms

Interventions

Denosumab

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System DiseasesNeoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Results Point of Contact

Title
Study Director
Organization
Amgen Inc.
866-572-6436

Study Officials

  • MD

    Amgen

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 30, 2009

First Posted

August 3, 2009

Study Start

July 1, 2009

Primary Completion

February 1, 2012

Study Completion

April 1, 2012

Last Updated

February 11, 2014

Results First Posted

February 11, 2014

Record last verified: 2013-12

Locations

GB(8)CZ(9)