Trials Sponsors Conditions Drugs Pricing

Conditions

Bone Metastases in Men With Hormone-Refractory Prostate Cancer Bone Metastases in Subjects With Advanced Breast Cancer Bone 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.

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:

Sponsors & Collaborators

Amgen
Industrylead

Study Sites (17)

Research Site

Jindřichův Hradec, 377 01, Czechia

Research Site

Kroměříž, 767 55, Czechia

Research Site

Olomouc, 775 20, Czechia

Research Site

Prague, 110 00, Czechia

Research Site

Prague, 140 00, Czechia

Research Site

Prague, 140 44, Czechia

Research Site

Prague, 150 06, Czechia

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 Diseases

Results Point of Contact

Title: Study Director
Organization: Amgen Inc.

Study Officials

MD
Amgen
STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee: No
Restriction Type: OTHER
Restrictive Agreement: Yes

Enrollment

35 participants (actual enrollment reported by the registry).

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 2009

Date type not reported

This date has not been verified as actual or estimated.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

1

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (17)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Intervention Hierarchy (Ancestors)

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

1

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (17)

Related Links

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Intervention Hierarchy (Ancestors)

Source record

Locations