Ignite Creation Date:
2024-05-05 @ 5:11 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00400829
Status:
COMPLETED
Last Update Posted:
2015-01-07
First Post:
2006-11-16
Brief Title:
E7389 in Treating Patients With Recurrent or Progressive Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase 2 Study of the Halichondrin B Analog E7389 in Patients With Advanced Non-Small Cell Lung Cancer NSCLC Previously Treated With a Taxane
Status:
COMPLETED
Status Verified Date:
2013-10
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:
This phase II trial is studying how well E7389 works in treating patients with recurrent or progressive stage IIIB or stage IV non-small cell lung cancer Drugs used in chemotherapy such as E7389 work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing
Detailed Description:
OBJECTIVES
I Evaluate the antitumor activity of E7389 eribulin mesylate in terms of objective response rate in patients with recurrent or progressive stage IIIB or IV non-small cell lung cancer
II Evaluate the time to progression and overall survival of patients treated with this drug
III Evaluate the toxicity profile of this drug in these patients
OUTLINE This is a multicenter study
Patients receive eribulin mesylate IV over 1-2 minutes on days 1 and 8 Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed once monthly for at least 6 months and then periodically thereafter
I Evaluate the antitumor activity of E7389 eribulin mesylate in terms of objective response rate in patients with recurrent or progressive stage IIIB or IV non-small cell lung cancer
II Evaluate the time to progression and overall survival of patients treated with this drug
III Evaluate the toxicity profile of this drug in these patients
OUTLINE This is a multicenter study
Patients receive eribulin mesylate IV over 1-2 minutes on days 1 and 8 Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed once monthly for at least 6 months and then periodically thereafter
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 |
|---|---|---|---|
| N01CM62209 | NIH | CTEP | httpsreporternihgovquickSearchN01CM62209 |
| NCI-2009-01159 | REGISTRY | None | None |
| CDR0000514516 | None | None | None |
| PHII-74 | OTHER | None | None |
| 7437 | OTHER | None | None |
| N01CM62204 | NIH | None | None |
| N01CM62201 | NIH | None | None |