Ignite Creation Date:
2024-05-06 @ 3:16 PM
Last Modification Date:
2024-10-26 @ 1:46 PM
Study NCT ID:
NCT04577703
Status:
COMPLETED
Last Update Posted:
2020-10-08
First Post:
2020-09-16
Brief Title:
First-In-Human Phase I Trial of Ningetinib CT053PTSA in the Patients With Advanced Solid Tumors
Sponsor:
Sunshine Lake Pharma Co Ltd
Organization:
Sunshine Lake Pharma Co Ltd
Study Overview
Official Title:
Safety Tolerability Pharmacokinetics and Preliminary Antitumor Activity of Ningetinib CT053PTSA in Patients With Advanced Solid Tumors A Phase I Single-arm Single-center Open-label Dose-escalation Study
Status:
COMPLETED
Status Verified Date:
2020-09
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 is a phase I single-arm single-center open-label dose-escalation Study evaluating the safety and efficacy of CT053PTSA in patients with Advanced Solid Tumors
Detailed Description:
This is a dose-escalation study The primary purpose is to determine the dose limiting toxicity DLT maximum tolerated dose MTD and recommend doses and regimen of CT053PTSA for further studies
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