Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00039429
Status:
COMPLETED
Last Update Posted:
2023-06-22
First Post:
2002-06-06
Brief Title:
Atrasentan in Treating Patients With Locally Recurrent or Metastatic Kidney Cancer
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
A Phase II Trial Evaluating Atrasentan In Patients With Advanced Renal Cell Carcinoma
Status:
COMPLETED
Status Verified Date:
2023-06
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 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
PURPOSE This phase II trial is studying how well atrasentan works in treating patients with locally recurrent or metastatic kidney cancer
PURPOSE This phase II trial is studying how well atrasentan works in treating patients with locally recurrent or metastatic kidney cancer
Detailed Description:
OBJECTIVES
Determine the 6-month progression-free survival rate in terms of proportion of those with measurable disease or bone metastases only of patients with locally recurrent or metastatic renal cell carcinoma treated with atrasentan measurable disease stratum closed to accrual as of 71604
Determine the toxicity of this drug in these patients
OUTLINE This is a multicenter study Patients are stratified according to prior immunotherapybiologic therapy yes vs no and characteristic of disease measurable vs bone metastases only measurable disease stratum closed to accrual as of 71604
Patients receive oral atrasentan once daily on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually for 5 years
PROJECTED ACCRUAL A total of 180 patients 90 per stratum with or without prior therapy will be accrued for this study within 6 months based on prior accrual the bone metastases only group specifically patients who have received 1 prior therapy is the only stratum open for accrual
Determine the 6-month progression-free survival rate in terms of proportion of those with measurable disease or bone metastases only of patients with locally recurrent or metastatic renal cell carcinoma treated with atrasentan measurable disease stratum closed to accrual as of 71604
Determine the toxicity of this drug in these patients
OUTLINE This is a multicenter study Patients are stratified according to prior immunotherapybiologic therapy yes vs no and characteristic of disease measurable vs bone metastases only measurable disease stratum closed to accrual as of 71604
Patients receive oral atrasentan once daily on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually for 5 years
PROJECTED ACCRUAL A total of 180 patients 90 per stratum with or without prior therapy will be accrued for this study within 6 months based on prior accrual the bone metastases only group specifically patients who have received 1 prior therapy is the only stratum open for accrual
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 |
|---|---|---|---|
| E6800 | None | None | None |