A Randomized, Double-Blind, Multicenter Study of Denosumab Compared With Zoledronic Acid Zometa 63720; in the Treatment of Bone Metastases in Subjects with Advanced Cancer Excluding Breast and Prostate Cancer or Multiple Myeloma - ND
- Conditions
- Treatment of bone metastases in subjects with advanced cancer excluding breast and prostate cancer or multiple myelomaMedDRA version: 6.1Level: PTClassification code 10027452
- Registration Number
- EUCTR2006-000848-65-IT
- Lead Sponsor
- Amgen Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1690
adult with histologically or cytologically confirmed advanced cancers including solid tumors, multiple myeloma, and lymphoma current or prior radiographic ie, x-ray, computer tomography CT , or magnetic resonance imaging MRI evidence of at least 1 bone metastasis or bone lesion from multiple myeloma Eastern Cooperative Oncology Group ECOG performance status of 0, 1, or 2 adequate organ function as defined by the following criteria 56256; 56451; serum aspartate aminotransferase AST 8804; 5 x upper limit of normal ULN 56256; 56451; serum alanine aminotransferase ALT 8804; 5 x ULN 56256; 56451; serum total bilirubin 8804; 2 x ULN 56256; 56451; creatinine clearance Cockcroft-Gault 8805; 30 mL/min 56256; 56451; albumin-adjusted serum calcium 8805; 2.0 mmol/L 8.0 mg/dL and 8804; 2.9 mmol/L 11.5 mg/dL Before any study-specific procedure is performed, the appropriate written informed consent must be obtained
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
diagnosis of breast or prostate cancer current or prior IV bisphosphonate administration current or prior oral bisphosphonate for the treatment of bone metastasis / osteolytic lesion planned radiation therapy or surgery to bone prior administration of denosumab known brain metastases life expectancy less than 6 months prior history or current evidence of osteonecrosis/osteomyelitis of the jaw active dental or jaw condition which requires oral surgery non-healed dental/oral surgery planned invasive dental procedure over the course of the study evidence of any of the following conditions per subject self report or medical chart review any other prior malignancy other than basal cell carcinoma or in situ cervical cancer with active disease within 3 years before randomization 56256; 56451; known infection with human immunodeficiency virus 56256; 56451; active infection with Hepatitis B virus or Hepatitis C virus any organic or psychiatric disorder that, in the opinion of the investigator, might prevent the subject from completing the study or interfere with the interpretation of the study results thirty days or less since receiving an investigational product or device ie, does not have marketing authorization in another clinical trial pregnant or breast feeding women subject with reproductive potential who will not agree to use effective contraception as defined by the principal investigator or designee 56256; 56451; known sensitivity to any of the products to be administered during the study eg, zoledronic acid, mammalian derived products, calcium or vitamin D
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine if denosumab is non-inferior to zoledronic acid with respect to the first on-study occurrence of a skeletal related event SRE in subjects with advanced cancers and bone metastases;Secondary Objective: To determine if denosumab is superior to zoledronic acid with respect to the first on-study SRE To determine if denosumab is superior to zoledronic acid with respect to the first-and-subsequent on-study SRE multiple event analysis To compare the treatment effect of denosumab with zoledronic acid on pain To compare the treatment effect of denosumab with zoledronic acid on the first on-study use of radiation to bone To assess the safety and tolerability of denosumab compared with zoledronic acid;Primary end point(s): time to the first on-study SRE non-inferiority
- Secondary Outcome Measures
Name Time Method