Ignite Creation Date:
2025-12-24 @ 3:59 PM
Ignite Modification Date:
2025-12-24 @ 3:59 PM
Study NCT ID:
NCT03888092
Status:
COMPLETED
Last Update Posted:
2023-03-21
First Post:
2019-03-18
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Z650 in Advanced Esophageal Squamous Cell Carcinoma With EGFR Over Expression or Gene Amplification
Sponsor:
Sunshine Lake Pharma Co., Ltd.
Organization:
Study Overview
Official Title:
A Phase Ib, Multi-center, Open-label Study of Z650 in Advanced Esophageal Squamous Cell Carcinoma (ECSS) With Epidermal Growth Factor Receptor (EGFR) Over Expression or Gene Amplification
Status:
COMPLETED
Status Verified Date:
2022-05
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 evaluate the safety and efficacy of Z650 in Advanced Esophageal Squamous Cell Carcinoma patients With EGFR Over expression or Gene Amplification.
Detailed Description:
It is a multi-center , open-label, singer arm study to explore the safety and efficacy of Z650 in advanced ESCC patients who had experienced systematic chemotherapy. Approximately 45 subjects will be enrolled, each subjects will receive oral Z650, at dose of 350 mg/d, repeatedly until disease progression or unacceptable toxicity occurs, each cycle is defined as 28 days.
Study Oversight
Has Oversight DMC:
False
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?: