Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00415324
Status:
COMPLETED
Last Update Posted:
2014-05-20
First Post:
2006-12-20
Brief Title:
Eribulin Mesylate and Cisplatin in Treating Patients With Advanced Solid Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase 1 Study of Halichondrin B Analog E7389 in Combination With Cisplatin in Advanced Solid Tumors
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:
This trial is studying the side effects and best dose of eribulin mesylate and cisplatin in treating patients with advanced solid tumorsDrugs used in chemotherapy such as eribulin mesylate and cisplatin work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving more than one drug combination chemotherapy may kill more tumor cells
Detailed Description:
Primary Objectives
I To determine the maximum tolerated dose of E7389 and cisplatin in patients with advanced solid tumors
II To determine the safety and toxicity of this regimen in these patients III To determine the pharmacokinetics of this regimen in these patients
Outline This is a multicenter dose-escalation study Patients receive eribulin mesylate IV over 5 minutes on days 1 8 and 15 and cisplatin IV over 30-60 minutes on day 1 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed for up to 8 weeks
I To determine the maximum tolerated dose of E7389 and cisplatin in patients with advanced solid tumors
II To determine the safety and toxicity of this regimen in these patients III To determine the pharmacokinetics of this regimen in these patients
Outline This is a multicenter dose-escalation study Patients receive eribulin mesylate IV over 5 minutes on days 1 8 and 15 and cisplatin IV over 30-60 minutes on day 1 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed for up to 8 weeks
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 |
|---|---|---|---|
| P30CA033572 | NIH | CTEP | httpsreporternihgovquickSearchP30CA033572 |
| NCI-2009-00168 | REGISTRY | None | None |
| PHI-55 | None | None | None |
| CDR0000518290 | None | None | None |
| PHI-55 | OTHER | None | None |
| 7427 | OTHER | None | None |
| U01CA062505 | NIH | None | None |