Ignite Creation Date:
2024-05-06 @ 9:21 AM
Last Modification Date:
2024-10-26 @ 12:13 PM
Study NCT ID:
NCT02965885
Status:
COMPLETED
Last Update Posted:
2024-06-27
First Post:
2016-11-10
Brief Title:
A Study of TAS-116 in Patients With Solid Tumors
Sponsor:
Taiho Oncology Inc
Organization:
Taiho Oncology Inc
Study Overview
Official Title:
A Phase IAIB Study Evaluating TAS-116 in Patients With Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2024-08
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:
A First-in-Human FIH study of TAS-116 in patients with advanced solid tumors was first initiated in Japan in April 2014 and has been ongoing since then The study consists of a dose escalation phase and a dose expansion phase Three dosing regimens of TAS-116 once daily QD every other day QOD and 5 days on2 days off regimens in 21-day cycles are being evaluated This phase I study is also planned to enroll patients with advanced solid tumors in UK to confirm the MTD safety tolerability and pharmacokinetics of TAS-116 in a Western patient population in the dose expansion phase In addition patients with HER2 MBC NSCLC harboring EGFR mutations or NSCLC harbouring ALK translocations will be further evaluated for safety tolerability and efficacy in 3 separate cohorts at recommended dose of TAS-116 on the 5 days on2 days off regimen
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 10058010 | OTHER | None | None |
| 2015-005328-24 | EUDRACT_NUMBER | Taiho Oncology Inc | None |