Titles and Background Information

Secondary ID: NOT APPLICABLE

Abbreviated Protocol Title (Brief Title): Double-blind study of denosumab compared with zoledronic acid in the treatment of bone metastases in subjects with advanced cancer (excluding breast and prostate cancer) or multiple myeloma

Full Protocol Title (Official Title): 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.

Is protocol conducted under a US IND?: yes

Investigational New Drug Application (IND)/Investigational Device Exemption (IDE) Information

IND/IDE Grantor: CDER

IND/IDE Number: 9838

IND/IDE Serial Number: 92

Has Expanded Access?: No

Sponsors

Sponsor: Amgen

Collaborator: N/A

Study Description

Brief Summary:
The purpose of this study is to determine if denosumab is non-inferior to zoledronic acid (Zometa®) in the treatment of bone metastases (lytic bone lesions from multiple myeloma) in subjects with advanced cancer and multiple myeloma (excluding breast and prostate cancer)

Detailed Description:

Status

Study Type: interventional

Status: Active, not recruiting

Record Verification Date: Aug-2010

Study Start Date: Jun-2006

Primary Completion Date: Apr-2009 (Actual)

Study Completion Date: Oct-2011 (Anticipated)

Study Design

Primary Purpose: Supportive Care

Phase: Phase 3

Allocation: Randomized

Masking: Double Blind (Masked Subject,Masked Investigator)

Study Design (Assignment): Parallel Assignment

Study Classification (Endpoint): Safety/Efficacy Study

Primary Outcomes: None

Secondary Outcomes: None

Interventions

Arms:

 Label: denosumab placebo with active zoledronic acid
 Type: Active Comparator

 Label: denosumab with zoledronic acid placebo
 Type: Experimental

Interventions:

 Type: Biological/Vaccine
 Name: Denosumab
 Description: 120 mg SC Q4W
 Associated Arms: denosumab with zoledronic acid placebo

 Type: Drug
 Name: Zoledronic Acid
 Description: 4mg IV Zoledronic Acid over minimum 15 minutes Q4W
 Associated Arms: denosumab placebo with active zoledronic acid
  other name: Zometa

Conditions and Keywords

Conditions: Bone Metastases

Keywords: advanced cancer

Keywords: Bone metastases

Keywords: denosumab

Keywords: lymphoma

Keywords: lytic bone lesions

Keywords: multiple myeloma

Keywords: skeletal fractures

Keywords: skeletal related events

Keywords: solid tumors

Keywords: spinal cord compressions, radiation to bone

Keywords: surgery to bone, bisphosphonates

Eligibility

Eligibility:

Inclusion Criteria:
- Adults with histologically/cystologically confirmed advanced cancers including solid tumors, multiple myeloma, and lymphoma
- Radiographic evidence of at least one bone metastasis (or lytic bone lesion from multiple myeloma); ECOG PS 0, 1, or 2
- Adequate organ function

Exclusion Criteria:
- Diagnosis of breast or prostate cancer
- Current or prior IV bisphosphonate administration
- Current or prior oral bisphosphonates for bone mets, life expectancy of less than 6 months
- Prior history or current evidence of osteonecrosis/osteomyelitis of the jaw

Gender: Both

Age limits:

Minimum Age: 18 years

Maximum Age: N/A

Enrollment: 1779 (Actual)

Healthy Volunteers: No