Open-Label access Protocol of Denosumab for Subjects with Advanced Cancer
- Conditions
- Bone metastases in subjects with advanced cancer
- Registration Number
- JPRN-jRCT1080221825
- Lead Sponsor
- DAIICHISANKYO Co.,Ltd.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 129
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.
-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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>Subject incidence of treatment-emergent adverse events
- Secondary Outcome Measures
Name Time Method other<br>Subject incidence of anti-denosumab antibodies