Skip to main content
OpenTrials
Completed

NCT Number: NCT01419717

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Bone Metastases in Men With Hormone-Refractory Prostate Cancer Bone Metastases in Subjects With Advanced Breast Cancer Breast Diseases Breast Neoplasms Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Skin Diseases Skin and Connective Tissue Diseases Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Capital Federal, Buenos Aires, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subject 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.

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 methods 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.

Treatment and study plan

Denosumab

Drug

Administered by subcutaneous injection every 4 weeks (Q4W)

Other names: Xgeva

Primary outcomes

  1. Number of Participants With Adverse Events

    Time frame: From first dose of denosumab in Study 20110113 to end of study; median (minimum, maximum) time on study was 13.93 (0.0, 74.7) months.

    An adverse event (AE) is defined as any untoward medical occurrence in a clinical trial participant. The event does not necessarily have a causal relationship with study treatment.

    Each AE was graded for severity according to the Common Terminology Criteria for Adverse Events (CTCAE) version 3.0, where Grade 1 = Mild AE Grade 2 = Moderate AE Grade 3 = Severe AE Grade 4 = Life-threatening or disabling AE Grade 5 = Death related to AE. Treatment-related adverse events (TRAEs) includes events for which the investigator indicated there was a reasonable possibility they may have been caused by investigational product.

Secondary outcomes

  1. Number of Participants With Anti-denosumab Binding Antibodies

    Time frame: Assessed at end of study; the median (minimum, maximum) time on study for all enrolled participants was 13.9 (0.0, 74.7) months.

    A blood sample was collected at the end of study visit for the measurement of anti-denosumab binding antibodies.

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Important dates

Study start
2011
Primary completion
2018
Study completion
2018
First posted
Aug 18, 2011
Registry last updated
Sep 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.