A Randomized, Double-Blind, Multicenter Study of Denosumab Compared With Zoledronic Acid (Zometa) in the Treatment of Bone Metastases in Subjects with Advanced Cancer (Excluding Breast and Prostate Cancer) or Multiple Myeloma
- Conditions
- Bone Metastases in Subjects with Advanced Cancer (Excluding Breast and Prostate Cancer) and Multiple Myeloma. Cancer (Except Breast and Prostate Cancer) spread to bone and Kahler's disease.1000595910027656
- Registration Number
- NL-OMON30155
- Lead Sponsor
- Amgen Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 18
- 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 lytic 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:
* serum aspartate aminotransferase (AST) * 5 x upper limit of normal (ULN)
* serum alanine aminotransferase (ALT) * 5 x ULN
* serum total bilirubin * 2 x ULN
* creatinine clearance (Cockroft-Gault) * 30 mL/min
* albumin-adjusted serum calcium * 2.0 mmol/L (8.0 mg/dL) and * 2.9 mmol/L (11.5 mg/dL). ;- Before any study-specific procedure is performed, the appropriate written informed consent must be obtained.
- 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
* known infection with human immunodeficiency virus
* active infection with Hepatitis B 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; thalidomide use is allowed) 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).
- 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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Time to the first on-study SRE (non-inferiority) </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary Efficacy Endpoints<br /><br>- time to the first on-study SRE (superiority)<br /><br>- time to the first-and-subsequent on-study SRE (superiority, using multiple<br /><br>event analysis)<br /><br><br /><br>Safety Endpoints<br /><br>- subject incidence of treatment-emergent adverse events<br /><br>- changes in laboratory values<br /><br>- Incidence of anti-denosumab antibody (binding and neutralizing) formation </p><br>