Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-28 @ 5:40 PM
Study NCT ID:
NCT03736850
Status:
COMPLETED
Last Update Posted:
2021-01-12
First Post:
2018-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of CS3006 in Subjects With Locally Advanced or Metastatic Solid Tumors
Sponsor:
CStone Pharmaceuticals
Organization:
Study Overview
Official Title:
A Phase I, Open Label, Multiple Dose, Dose Escalation and Expansion Study to Investigate the Safety, Tolerability, Pharmacokinetics and Antitumor Activities of the MEK Inhibitor CS3006 in Subjects With Locally Advanced or Metastatic Solid Tumors
Status:
COMPLETED
Status Verified Date:
2020-03
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 multicenter, open label, sequential-cohort, dose escalation \& expansion phase I study to evaluate the clinical safety, tolerability, PK, and preliminary efficacy of CS3006 and to establish the Maximum Tolerated Dose (MTD）, if any, Recommended Phase II Doses (RP2Ds) and regimen of CS3006. The study is composed of two parts: Part 1 for dose escalation and Part 2 for dose expansion.
Detailed Description:
None
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?: