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

NCT01419717 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 129

Last updated 2019-09-24

Study results available
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Summary

This trial will facilitate access to denosumab for adults with advanced cancer who have participated in a denosumab phase 3 study until denosumab is approved and available for sale.

Conditions

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

Interventions

DRUG

Denosumab

Administered by subcutaneous injection every 4 weeks (Q4W)

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-22
Primary Completion
2018-08-10
Completion
2018-08-10

Countries

  • Argentina
  • Austria
  • Belgium
  • Brazil
  • Czechia
  • France
  • Hungary
  • Israel
  • Italy
  • Japan
  • Latvia
  • Lithuania
  • Panama
  • Peru
  • Poland
  • Russia
  • South Africa
  • Spain
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01419717 on ClinicalTrials.gov