Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00072059
Status:
COMPLETED
Last Update Posted:
2013-07-18
First Post:
2003-11-04
Brief Title:
Ro 50-3821 in Treating Anemia in Patients Receiving Antineoplastic Therapy for Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
An Open Label Randomized Multicenter Phase II Study To Determine Hemoglobin Dose Response Safety And Pharmacokinetic Profile Of Ro 50-3821 Given Subcutaneously Once Weekly Or Once Every 3 Weeks To Anemic Patients With Stage IIIB or IV Non-Small Cell Lung Carcinoma Receiving Antineoplastic Therapy
Status:
COMPLETED
Status Verified Date:
2005-01
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 Ro 50-3821 may stimulate red blood cell production and treat anemia in patients who are receiving antineoplastic therapy for non-small cell lung cancer
PURPOSE This randomized phase II trial is studying six different regimens of Ro 50-3821 to compare how well they work in treating anemia in patients who are receiving antineoplastic therapy for stage IIIB or stage IV non-small cell lung cancer
PURPOSE This randomized phase II trial is studying six different regimens of Ro 50-3821 to compare how well they work in treating anemia in patients who are receiving antineoplastic therapy for stage IIIB or stage IV non-small cell lung cancer
Detailed Description:
OBJECTIVES
Primary
Compare the hemoglobin dose response of anemic patients with stage IIIB or IV non-small cell lung cancer receiving antineoplastic therapy treated with 6 different regimens of Ro 50-3821
Secondary
Compare the safety profile of these regimens in these patients
Compare the pharmacokinetic profile of these regimens in these patients
Determine additional pharmacodynamic characteristics of these regimens in these patients
OUTLINE This is a randomized open-label parallel multicenter study Patients are randomized to 1 of 6 treatment arms In all arms patients begin study therapy on the first day of a course of antineoplastic therapy
Arm I Patients receive a lower dose of Ro 50-3821 subcutaneously SC once weekly
Arm II Patients receive a medium dose of Ro 50-3821 SC once weekly
Arm III Patients receive a higher dose of Ro 50-3821 SC once weekly
Arm IV Patients receive a lower dose of Ro 50-3821 SC once every 3 weeks
Arm V Patients receive a medium dose of Ro 50-3821 SC once every 3 weeks
Arm VI Patients receive a higher dose of Ro 50-3821 SC once every 3 weeks In all arms treatment continues for 12 weeks in the absence of unacceptable toxicity
Patients are followed at 1 week
PROJECTED ACCRUAL A total of 210 patients 35 per treatment arm will be accrued for this study
Primary
Compare the hemoglobin dose response of anemic patients with stage IIIB or IV non-small cell lung cancer receiving antineoplastic therapy treated with 6 different regimens of Ro 50-3821
Secondary
Compare the safety profile of these regimens in these patients
Compare the pharmacokinetic profile of these regimens in these patients
Determine additional pharmacodynamic characteristics of these regimens in these patients
OUTLINE This is a randomized open-label parallel multicenter study Patients are randomized to 1 of 6 treatment arms In all arms patients begin study therapy on the first day of a course of antineoplastic therapy
Arm I Patients receive a lower dose of Ro 50-3821 subcutaneously SC once weekly
Arm II Patients receive a medium dose of Ro 50-3821 SC once weekly
Arm III Patients receive a higher dose of Ro 50-3821 SC once weekly
Arm IV Patients receive a lower dose of Ro 50-3821 SC once every 3 weeks
Arm V Patients receive a medium dose of Ro 50-3821 SC once every 3 weeks
Arm VI Patients receive a higher dose of Ro 50-3821 SC once every 3 weeks In all arms treatment continues for 12 weeks in the absence of unacceptable toxicity
Patients are followed at 1 week
PROJECTED ACCRUAL A total of 210 patients 35 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 |
|---|---|---|---|
| CDR0000335429 | REGISTRY | PDQ Physician Data Query | None |
| UCLA-0303085 | None | None | None |