Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00051779
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2003-01-16
Brief Title:
An Investigational Drug CAL Versus Zoledronic Acid Zometa in Patients With Breast Cancer
Sponsor:
Chugai Pharma USA
Organization:
Chugai Pharma USA
Study Overview
Official Title:
A 24-Week Blinded Study Conducted at Multiple Centers Evaluating the Safety and Effectiveness of Various Doses of the Investigational Drug CAL Versus Zoledronic Acid Zometa When Randomly Assigned to Patients With Breast Cancer That Has Metastasized to Bone
Status:
COMPLETED
Status Verified Date:
2004-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is intended to evaluate the safety tolerability and possible effectiveness of an investigational humanized monoclonal antibody CAL to the parathyroid hormone-related protein PTHrP when compared to zoledronic acid in patients with breast cancer metastatic to bone
The study will also evaluate the possible effects of both study drugs on performance status markers of bone metabolism and skeletal events related to bone metastasis including elevated blood calcium levels bone pain metastatic lesions complications and interventions The levels of CAL in the blood will also be evaluated
The study will also evaluate the possible effects of both study drugs on performance status markers of bone metabolism and skeletal events related to bone metastasis including elevated blood calcium levels bone pain metastatic lesions complications and interventions The levels of CAL in the blood will also be evaluated
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None