Ignite Creation Date:
2024-05-05 @ 5:06 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00386152
Status:
TERMINATED
Last Update Posted:
2013-07-19
First Post:
2006-10-06
Brief Title:
A Study Comparing Two Different PROCRIT Doses to a Dose of ARANESP in Anemic Cancer Patients Receiving Chemotherapy
Sponsor:
Johnson Johnson Pharmaceutical Research Development LLC
Organization:
Johnson Johnson Pharmaceutical Research Development LLC
Study Overview
Official Title:
A Randomized Open-Label Comparative Study of Epoetin Alfa PROCRIT 80000 Units or 120000 Units Q3W Every 3 Weeks Versus Darbepoetin Alfa ARANESP 500 Mcg Q3W in Anemic Cancer Subjects Receiving Chemotherapy
Status:
TERMINATED
Status Verified Date:
2013-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No safety signals were noted The study was stopped because it was no longer consistent with the companys scientific and strategic focus
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to compare hemoglobin response rates between two PROCRIT epoetin alfa doses and ARANESP darbepoetin alfa in anemic cancer patients receiving chemotherapy
Detailed Description:
This is an open-label both the physician and the patient know which treatment is being provided multi-center study of up to 16 weeks duration in which 450 patients will be randomly assigned patients are assigned to a specific study group by chance to one of three treatment groups in a 111 ratio Patients will receive PROCRIT epoetin alfa 80000 Units injected subcutaneously under the skin once every three weeks or 120000 Units injected under the skin once every three weeks or ARANESP darbepoetin alfa 500 mcg injected under the skin once every three weeks for up to 13 weeks PROCRIT epoetin alfa 80000 Units and 120000 Units given once every three weeks are doses and schedules that are not approved for use in the United States and are under investigation while the ARANESP dose and schedule are approved for use in the United States Adult patients with specific types of cancer confirmed non-myeloid malignancy who are scheduled to receive cyclic chemotherapy for a minimum of 12 weeks during the study and who meet all other eligibility criteria will be enrolled This study will be conducted in approximately 80 study sites located in the United States
The study hypothesis is that a dosing regimen of PROCRIT Epoetin alfa 80000 Units or 120000 Units given once every three weeks is non-inferior to ARANESP 500 mcg given once every three weeks with respect to the mean hemoglobin Hb change from baseline to Study Week 7 in anemic cancer patients receiving chemotherapy Hemoglobin levels will be monitored throughout the study on a weekly basis and before each drug dose is administered Drug dosing will be adjusted ie held reduced resumed at a lower dose as needed to maintain hemoglobin values within desired ranges
The maximum dose of PROCRIT Epoetin alfa allowed in this study is 120000 Units every three weeks Q3W and the maximum dose of ARANESP darbepoetin is 500 mcg Q3W
Safety evaluations will be conducted throughout the study and will consist of assessment of laboratory tests vital signs physical examinations The occurrence and severity of adverse events including thrombovascular events will be evaluated throughout the studyPeriodic data monitoring of the study by an external Independent Data Monitoring Committee IDMC will be performed The main responsibility of the IDMC is to conduct ongoing monitoring of safety and to report any irregularities back to the Sponsor along with recommendations regarding continuation of the study Each patient will be assigned to one of three dosing schedules All schedules will be administered by way of subcutaneous under the skin injection once every three weeks over a period of 13 weeks The three dosing schedules are as follows PROCRIT epoetin alfa 80000 Units PROCRIT epoetin alfa 120000 Units or ARANESP darbepoetin alfa 500 mcg
The study hypothesis is that a dosing regimen of PROCRIT Epoetin alfa 80000 Units or 120000 Units given once every three weeks is non-inferior to ARANESP 500 mcg given once every three weeks with respect to the mean hemoglobin Hb change from baseline to Study Week 7 in anemic cancer patients receiving chemotherapy Hemoglobin levels will be monitored throughout the study on a weekly basis and before each drug dose is administered Drug dosing will be adjusted ie held reduced resumed at a lower dose as needed to maintain hemoglobin values within desired ranges
The maximum dose of PROCRIT Epoetin alfa allowed in this study is 120000 Units every three weeks Q3W and the maximum dose of ARANESP darbepoetin is 500 mcg Q3W
Safety evaluations will be conducted throughout the study and will consist of assessment of laboratory tests vital signs physical examinations The occurrence and severity of adverse events including thrombovascular events will be evaluated throughout the studyPeriodic data monitoring of the study by an external Independent Data Monitoring Committee IDMC will be performed The main responsibility of the IDMC is to conduct ongoing monitoring of safety and to report any irregularities back to the Sponsor along with recommendations regarding continuation of the study Each patient will be assigned to one of three dosing schedules All schedules will be administered by way of subcutaneous under the skin injection once every three weeks over a period of 13 weeks The three dosing schedules are as follows PROCRIT epoetin alfa 80000 Units PROCRIT epoetin alfa 120000 Units or ARANESP darbepoetin alfa 500 mcg
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EPOANE2007 | OTHER | Johnson Johnson Pharmaceutical Research and Development LLC | None |