Ignite Creation Date:
2024-05-06 @ 10:14 AM
Last Modification Date:
2024-10-26 @ 12:27 PM
Study NCT ID:
NCT03207672
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-20
First Post:
2017-06-19
Brief Title:
Study of E7389 Liposomal Formulation in Participants With Solid Tumor
Sponsor:
Eisai Co Ltd
Organization:
Eisai Inc
Study Overview
Official Title:
An Open-label Phase 1 Study of E7389 Liposomal Formulation in Subjects With Solid Tumor
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
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:
The maximum tolerated dose MTD of E7389 liposomal formulation E7389-LF will be determined in the dose escalation part Safety pharmacokinetics PK and efficacy will be assessed using treatment regimen evaluated in dose escalation part in participants with breast cancer up to 3 prior regimens of chemotherapy in the expansion part 1 and in participants with adenoid cystic carcinoma ACC gastric cancer GC esophageal cancer EGC small cell lung cancer SCLC and breast cancer with no prior regimens of chemotherapy in the expansion part 2 3 4 5 and 6 respectively
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None