Ignite Creation Date:
2024-05-06 @ 2:12 PM
Last Modification Date:
2024-10-26 @ 1:27 PM
Study NCT ID:
NCT04247126
Status:
COMPLETED
Last Update Posted:
2023-10-27
First Post:
2020-01-22
Brief Title:
A Study of SY 5609 a Selective CDK7 Inhibitor in Advanced Solid Tumors
Sponsor:
Syros Pharmaceuticals
Organization:
Syros Pharmaceuticals
Study Overview
Official Title:
A Phase 1 Study of SY 5609 an Oral Selective CDK7 Inhibitor in Adult Patients With Select Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2023-10
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 study consists of 2 parts Part 1 is dose escalation and will first administer SY-5609 alone to participants with select advanced solid tumors and then in combination with fulvestrant to participants with HR positive HER2-negative breast cancer Part 2 is a dose expansion and will first administer SY-5609 in combination with gemcitabine and then SY-5609 in combination with gemcitabine and nab-paclitaxel in participants with pancreatic ductal adenocarcinoma PDAC
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?:
None