Ignite Creation Date:
2025-12-24 @ 10:53 PM
Ignite Modification Date:
2025-12-25 @ 8:22 PM
Study NCT ID:
NCT02467569
Status:
TERMINATED
Last Update Posted:
2024-03-01
First Post:
2015-06-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study Evaluating Hemay020 In Subjects With Advanced Solid Cancer
Sponsor:
Tianjin Hemay Pharmaceutical Co., Ltd
Organization:
Study Overview
Official Title:
Phase I Trial Evaluating Pharmacokinetics, Safety and Tolerability of the Irreversible Epidermal Growth Factor Receptor Inhibitor Hemay020 in Patients With Advanced Solid Cancer
Status:
TERMINATED
Status Verified Date:
2024-02
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 assess the pharmacokinetics，safety and tolerability of Hemay020 and to determine the recommended dose for future Phase II study as well as to obtain preliminary information on the efficacy of Hemay020 in subjects with solid tumors. The study will be conducted in two parts. Part one, testing will be done on up to 16-31 subjects to determine the safety and tolerability of Hemay 020 in patients with advanced solid tumors. Part two, another 16-24 subjects with advanced or metastatic NSCLC, will be added to the trial to better define the tolerability and preliminary efficacy of Hemay020.
Detailed Description:
This is a phaseâ… sequential-group study of ascending single and multiple oral doses administered to subjects with advanced solid tumors. Each subject will receive a single dose of Hemay020, followed by a 2-week observation period, and then will receive Hemay020 administered once daily by mouth for 28 days. Each cycle consist of 28 days. Subjects will be enrolled in groups of 3 to 6. Depending on the safety and activity profile observed during the dose escalation phase, the dose selected for Part 2 may be adjusted. Part 2 is an extension part of two dose groups administered to subjects with NSCLC.
Study Oversight
Has Oversight DMC:
False
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?: