Ignite Creation Date:
2025-12-24 @ 3:03 PM
Ignite Modification Date:
2026-02-27 @ 10:33 AM
Study NCT ID:
NCT00072059
Status:
COMPLETED
Last Update Posted:
2013-07-18
First Post:
2003-11-04
Is Gene Therapy:
True
Has Adverse Events:
False
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:
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?: