Clinical trial to evaluate the efficacy of drug product Denosumab in patients with advance cancer.
- Conditions
- Health Condition 1: null- Bone Metastases in Men With Hormone-Refractory Prostate CancerBone Metastases in Subjects With Advanced Breast CancerHealth Condition 2: D499- Neoplasm of unspecified behavior of unspecified site
- Registration Number
- CTRI/2012/10/003055
- Lead Sponsor
- Amgen Technology Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 400
Subject was previously enrolled in a denosumab phase three study and participated in the Open label Extension portion of that study.
Subject or subjects 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 investigators 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 Subject incidence of treatment-emergent adverse eventsTimepoint: [ Time Frame: Study duration (expected to be approximately 1 year per subject) ] [ Designated as safety issue: Yes ] <br/ ><br> <br/ ><br> <br/ ><br>
- Secondary Outcome Measures
Name Time Method Subject incidence of anti-denosumab antibodiesTimepoint: [ Time Frame: Study duration (expected to be approximately 1 year per subject) ] [ Designated as safety issue: No ] <br/ ><br> <br/ ><br> <br/ ><br>