Ignite Creation Date:
2025-12-24 @ 5:15 PM
Ignite Modification Date:
2025-12-24 @ 5:15 PM
Study NCT ID:
NCT03976050
Status:
TERMINATED
Last Update Posted:
2020-11-18
First Post:
2019-06-02
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase I Study of HL-085 in Patients With Advanced Solid Tumors
Sponsor:
Shanghai Kechow Pharma, Inc.
Organization:
Study Overview
Official Title:
A Phase I, Single Arm, Dose Escalation Study to Evaluate Safety, Pharmacokinetics and Preliminary Efficacy of HL-085 in Subjects With Advanced Solid Tumors
Status:
TERMINATED
Status Verified Date:
2020-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study objective and design change
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study drug, HL-085 is a MEK inhibitor with the potential indication for cancers. It is an oral medication to be given daily.
The purposes of this study is to find answers to the following research questions:
1. What is the highest tolerable dose of HL-085 that can be given to subjects when given orally (by mouth) on a twice daily basis?
2. What are the side effects of HL-085?
3. How much HL-085 is in the blood at specific times after dosing and how does the body get rid of the HL-085?
The purposes of this study is to find answers to the following research questions:
1. What is the highest tolerable dose of HL-085 that can be given to subjects when given orally (by mouth) on a twice daily basis?
2. What are the side effects of HL-085?
3. How much HL-085 is in the blood at specific times after dosing and how does the body get rid of the HL-085?
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?: