Ignite Creation Date:
2024-05-05 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00047034
Status:
COMPLETED
Last Update Posted:
2013-01-07
First Post:
2002-10-03
Brief Title:
E7389 in Treating Patients With Advanced Solid Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase I Trial of E7389 Halichondrin B Analog NSC 707389 in Patients With Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2013-01
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:
Phase I trial to study the effectiveness of E7389 in treating patients who have advanced solid tumors Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die
Detailed Description:
PRIMARY OBJECTIVES
I To determine the maximum tolerated dose MTD of E7389 administered as an IV bolus over 1-2 minutes weekly for 3 weeks
II To describe the toxicities of E7389 III To evaluate the pharmacokinetics of E7389 IV To determine the in vivo anti-mitotic activity of E7389 by cell cycle analysis and immunohistochemistry in pre- and post-treatment tumor biopsies
OUTLINE This is a dose-escalation multicenter study
Patients receive E7389 IV over 1-2 minutes on days 1 8 and 15 Treatment repeats every 4 weeks for at least 4 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of E7389 until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose-limiting toxicity
I To determine the maximum tolerated dose MTD of E7389 administered as an IV bolus over 1-2 minutes weekly for 3 weeks
II To describe the toxicities of E7389 III To evaluate the pharmacokinetics of E7389 IV To determine the in vivo anti-mitotic activity of E7389 by cell cycle analysis and immunohistochemistry in pre- and post-treatment tumor biopsies
OUTLINE This is a dose-escalation multicenter study
Patients receive E7389 IV over 1-2 minutes on days 1 8 and 15 Treatment repeats every 4 weeks for at least 4 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of E7389 until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose-limiting toxicity
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 |
|---|---|---|---|
| CDR0000257235 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU01CA062505 |
| PHI-39 | None | None | None |
| U01CA062505 | NIH | None | None |