Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00060138
Status:
COMPLETED
Last Update Posted:
2013-05-15
First Post:
2003-05-06
Brief Title:
Monoclonal Antibody Compared With Zoledronate in Treating Women With Breast Cancer and Bone Metastases
Sponsor:
Chugai Pharmaceutical
Organization:
Chugai Pharmaceutical
Study Overview
Official Title:
A Phase I-II 24-Week Multi-Center Double-Blind Randomized Dose-Ranging Study To Evaluate The Safety And Efficacy Of A Humanized Monoclonal Antibody To PTHrP Versus Zoledronic Acid In Patients With Breast Cancer Metastatic To Bone
Status:
COMPLETED
Status Verified Date:
2013-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells Zoledronate may prevent bone loss and stop the growth of tumor cells in bone It is not yet known whether monoclonal antibody is more effective than zoledronate in treating women who have breast cancer and bone metastases
PURPOSE Randomized phase III trial to compare the effectiveness of monoclonal antibody with that of zoledronate in treating women who have breast cancer and bone metastases
PURPOSE Randomized phase III trial to compare the effectiveness of monoclonal antibody with that of zoledronate in treating women who have breast cancer and bone metastases
Detailed Description:
OBJECTIVES
Compare the safety and tolerability of monoclonal antibody CAL vs zoledronate in women with breast cancer and bone metastases
Compare preliminarily the potential effects of these drugs on skeletal eventsmanifestations related to bone metastases including hypercalcemia bone pain bone metastatic lesions complications eg pathologic fracture and spinal cord compression and interventions eg surgery and radiotherapy in these patients
Compare changes in ECOG performance status in patients treated with these drugs
Determine the pharmacokinetics of monoclonal antibody CAL in these patients
OUTLINE This is a randomized double-blind multicenter study Patients are stratified according to average prestudy pain score on question 3 of a daily electronic telephone pain diary less than 3 vs 3 or more and prior bisphosphonate therapy yes vs no Patients are randomized to 1 of 4 treatment arms
Arm I Patients receive monoclonal antibody CAL IV over 30-60 minutes on day 1
Arm II Patients receive a lower dose of monoclonal antibody CAL as in arm I
Arm III Patients receive a lower dose lower than arm II of monoclonal antibody CAL as in arm I
Arm IV Patients receive zoledronate IV over 30-60 minutes on day 1 Treatment in all arms repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
Patients keep a pain diary throughout study participation
Patients are followed at 24 weeks
PROJECTED ACCRUAL A total of 72 patients 18 per treatment arm will be accrued for this study
Compare the safety and tolerability of monoclonal antibody CAL vs zoledronate in women with breast cancer and bone metastases
Compare preliminarily the potential effects of these drugs on skeletal eventsmanifestations related to bone metastases including hypercalcemia bone pain bone metastatic lesions complications eg pathologic fracture and spinal cord compression and interventions eg surgery and radiotherapy in these patients
Compare changes in ECOG performance status in patients treated with these drugs
Determine the pharmacokinetics of monoclonal antibody CAL in these patients
OUTLINE This is a randomized double-blind multicenter study Patients are stratified according to average prestudy pain score on question 3 of a daily electronic telephone pain diary less than 3 vs 3 or more and prior bisphosphonate therapy yes vs no Patients are randomized to 1 of 4 treatment arms
Arm I Patients receive monoclonal antibody CAL IV over 30-60 minutes on day 1
Arm II Patients receive a lower dose of monoclonal antibody CAL as in arm I
Arm III Patients receive a lower dose lower than arm II of monoclonal antibody CAL as in arm I
Arm IV Patients receive zoledronate IV over 30-60 minutes on day 1 Treatment in all arms repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity
Patients keep a pain diary throughout study participation
Patients are followed at 24 weeks
PROJECTED ACCRUAL A total of 72 patients 18 per treatment arm will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CBI-CAL-03 | Registry Identifier | PDQ Physician Data Query | None |
| CBI-1102 | None | None | None |
| CDR0000299530 | REGISTRY | None | None |