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

• Status: Completed
• Trial end date: 2018-08-10
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Treatments: Denosumab

Criteria

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.