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

Amgen

Status and phase

Completed

Phase 3

Conditions

Bone Metastases in Subjects With Advanced Breast Cancer

Bone Metastases in Men With Hormone-Refractory Prostate Cancer

Treatments

Drug: Denosumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT01419717

20110113

Details and patient eligibility

About

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.

Enrollment

129 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.