Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00054314
Status:
COMPLETED
Last Update Posted:
2022-09-26
First Post:
2003-02-05
Brief Title:
BAY 59-8862 in Treating Patients With Non-Small Cell Lung Cancer
Sponsor:
Roswell Park Cancer Institute
Organization:
Roswell Park Cancer Institute
Study Overview
Official Title:
An Uncontrolled Phase II Study Evaluating Anti-Tumor Efficacy and Safety of BAY 59-8862 in Patients With Taxane Resistant Non-Small Cell Lung Carcinoma NSCLC
Status:
COMPLETED
Status Verified Date:
2022-09
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 Phase II trial to study the effectiveness of BAY 59-8862 in treating patients who have non-small cell lung cancer
PURPOSE Phase II trial to study the effectiveness of BAY 59-8862 in treating patients who have non-small cell lung cancer
Detailed Description:
OBJECTIVES
Determine the overall response rate including partial and complete response in patients with taxane-resistant non-small cell lung cancer treated with BAY 59-8862
Determine the overall survival of patients treated with this drug
Determine duration of response and time to progression in patients treated with this drug
Determine the quantitative and qualitative toxic effects of this drug in these patients
OUTLINE This is a multicenter study
Patients receive BAY 59-8862 IV over 1 hour on day 1 Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity Patients with responding disease receive 2-4 additional courses beyond maximal response
Patients are followed every 3 months for 2 years and then every 6 months thereafter
PROJECTED ACCRUAL A total of 14-84 patients will be accrued for this study
Determine the overall response rate including partial and complete response in patients with taxane-resistant non-small cell lung cancer treated with BAY 59-8862
Determine the overall survival of patients treated with this drug
Determine duration of response and time to progression in patients treated with this drug
Determine the quantitative and qualitative toxic effects of this drug in these patients
OUTLINE This is a multicenter study
Patients receive BAY 59-8862 IV over 1 hour on day 1 Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity Patients with responding disease receive 2-4 additional courses beyond maximal response
Patients are followed every 3 months for 2 years and then every 6 months thereafter
PROJECTED ACCRUAL A total of 14-84 patients 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 |
|---|---|---|---|
| BAYER-10653 | None | None | None |
| RPCI-DS-0204 | None | None | None |