Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00147225
Status:
COMPLETED
Last Update Posted:
2014-05-08
First Post:
2005-09-06
Brief Title:
AMG 531 in Patients With Advanced Malignancy Receiving Treatment With Carboplatin
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Phase III Study of AMG 531 in Patients With Advanced Malignancy Receiving Treatment With Carboplatin
Status:
COMPLETED
Status Verified Date:
2014-04
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:
The goal of this clinical research study is to find the highest safe dose of AMG 531 that will decrease the risk and severity of thrombocytopenia low platelet counts in patients who have received chemotherapy Researchers will also look at the safety and effectiveness of AMG 531 Romiplostim
Primary Objectives
1 To determine the clinical safety and tolerability of AMG 531 administered following chemotherapy in patients with advanced malignancy
2 To determine an optimal biologic dose OBD of AMG 531 administered in patients receiving chemotherapy known to cause severe thrombocytopenia
3 To evaluate the effects of AMG 531 on the degree and duration of thrombocytopenia and platelet recovery following chemotherapy
Secondary Objective
1 To evaluate limited pharmacokinetics of AMG 531 administered by SC route post-chemotherapy
Primary Objectives
1 To determine the clinical safety and tolerability of AMG 531 administered following chemotherapy in patients with advanced malignancy
2 To determine an optimal biologic dose OBD of AMG 531 administered in patients receiving chemotherapy known to cause severe thrombocytopenia
3 To evaluate the effects of AMG 531 on the degree and duration of thrombocytopenia and platelet recovery following chemotherapy
Secondary Objective
1 To evaluate limited pharmacokinetics of AMG 531 administered by SC route post-chemotherapy
Detailed Description:
Platelets are cells that help make the blood clot A decrease in platelets can cause bleeding which may prevent or delay a patient from receiving chemotherapy Researchers want to find out if AMG 531 can lower the risk and severity of this side effect AMG 531 is a protein that stimulates platelet production
If you are eligible to take part in this study you will be assigned to 1 of 6 dosing schedules of study drug The dose of AMG 531 that you receive will depend on when you are enrolled
In Cycle 1 all patients will receive chemotherapy by itself Three 3 weeks later in Cycle 2 the same dose of chemotherapy will be given followed by AMG 531 AMG 531 will be given on one of 3 schedules AMG 531 will be given as an injection under the skin on the day after chemotherapy and 2 days later it will be given 5 days before and the day after chemotherapy or it will be given 5 and 3 days before chemotherapy and on the day after chemotherapy and 2 days later The schedule you receive will depend on when you enroll on the study After 2 cycles of treatment based on response of the disease and tolerance to the treatment all participants may be able to receive up to 4 more cycles of chemotherapy followed by AMG 531 All participants will continue on the same schedule you were receiving before The dose of AMG 531 may be increased at one time point during the study based on the response of the platelet counts
The number of blood tests drawn about 3 teaspoons each will depend on your clinical condition These samples will be taken at least 2 times a week and as often as once a day during portions of the study You will also have blood about 1 teaspoon collected for the evaluation of anti-AMG 531 antibody status before treatment starts at the end of Cycles 2 and 4 and at the end of study
You will be taken off the study if your disease gets worse or intolerable side effects occur At the end of the study you will have a medical history and physical exam including measurement of vital signs You will also have blood about 1 teaspoon drawn for routine tests
This is an investigational study AMG 531 is not FDA approved or commercially available At this time it is being used for research purposes only Up to 56 patients will take part in this study All will be enrolled at University of Texas UTMD Anderson
If you are eligible to take part in this study you will be assigned to 1 of 6 dosing schedules of study drug The dose of AMG 531 that you receive will depend on when you are enrolled
In Cycle 1 all patients will receive chemotherapy by itself Three 3 weeks later in Cycle 2 the same dose of chemotherapy will be given followed by AMG 531 AMG 531 will be given on one of 3 schedules AMG 531 will be given as an injection under the skin on the day after chemotherapy and 2 days later it will be given 5 days before and the day after chemotherapy or it will be given 5 and 3 days before chemotherapy and on the day after chemotherapy and 2 days later The schedule you receive will depend on when you enroll on the study After 2 cycles of treatment based on response of the disease and tolerance to the treatment all participants may be able to receive up to 4 more cycles of chemotherapy followed by AMG 531 All participants will continue on the same schedule you were receiving before The dose of AMG 531 may be increased at one time point during the study based on the response of the platelet counts
The number of blood tests drawn about 3 teaspoons each will depend on your clinical condition These samples will be taken at least 2 times a week and as often as once a day during portions of the study You will also have blood about 1 teaspoon collected for the evaluation of anti-AMG 531 antibody status before treatment starts at the end of Cycles 2 and 4 and at the end of study
You will be taken off the study if your disease gets worse or intolerable side effects occur At the end of the study you will have a medical history and physical exam including measurement of vital signs You will also have blood about 1 teaspoon drawn for routine tests
This is an investigational study AMG 531 is not FDA approved or commercially available At this time it is being used for research purposes only Up to 56 patients will take part in this study All will be enrolled at University of Texas UTMD Anderson
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