Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00121719
Status:
COMPLETED
Last Update Posted:
2023-06-22
First Post:
2005-07-15
Brief Title:
An Open Label Dose Escalation Study Of E7080
Sponsor:
Eisai Inc
Organization:
Eisai Inc
Study Overview
Official Title:
An Open Label Phase I Dose Escalation Study Of E7080
Status:
COMPLETED
Status Verified Date:
2020-03
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 purpose of this study is to determine the maximum tolerated dose MTD of lenvatinib in patients with solid tumors or lymphomas
Detailed Description:
This is an open-label non-randomized dose escalation study Patients will be treated with lenvatinib once daily Each four-week treatment period will be considered to be one treatment cycle The selection of subsequent dose levels will be performed according to an accelerated design Although initially 3 patients per dose level will be entered the next dose level can be opened for patient accrual after only the first patient in the previous cohort completes Cycle 1 with no drug-related toxicity greater than grade 1 except alopecia lymphopenia and anemia
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 |
|---|---|---|---|
| 2004-002265-21 | EUDRACT_NUMBER | None | None |