Ignite Creation Date:
2024-05-06 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 12:23 PM
Study NCT ID:
NCT03134638
Status:
TERMINATED
Last Update Posted:
2021-03-09
First Post:
2017-04-19
Brief Title:
A Study of SY-1365 in Adult Patients With Advanced Solid Tumors
Sponsor:
Syros Pharmaceuticals
Organization:
Syros Pharmaceuticals
Study Overview
Official Title:
A Phase 1 Study of SY-1365 a Selective CDK7 Inhibitor in Adult Patients With Advanced Solid Tumors
Status:
TERMINATED
Status Verified Date:
2019-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Business Decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study consists of two parts Part 1 is a dose-escalationsafety evaluation to provisionally identify a dose and regimen of SY-1365 for further evaluation in Part 2
Following the identification of a recommended dose and regimen from Part 1 the study entered Part 2 to further evaluate safety and the antitumor activity of SY-1365 in patients with select solid tumors and to confirm target engagement and downstream pathway impact in patients with any solid tumor histology
Following the identification of a recommended dose and regimen from Part 1 the study entered Part 2 to further evaluate safety and the antitumor activity of SY-1365 in patients with select solid tumors and to confirm target engagement and downstream pathway impact in patients with any solid tumor histology
Detailed Description:
This study consists of two parts Part 1 is a dose-escalationsafety evaluation to identify a dose and regimen for further evaluation in Part 2 SY-1365 will be administered intravenously weekly twice weekly for 3 weeks of each 4 week cycle Dose escalation will proceed until the determination of the maximum tolerated dose MTD or a recommended dose and regimen for evaluation in Part 2 of the study Part 1 was concluded in September 2018 with a total of 32 evaluable patients
Following the identification of a recommended dose and regimen from Part 1 the study entered Part 2 to further evaluate safety and the antitumor activity of SY-1365 in patients with select solid tumors and to confirm target engagement and downstream pathway impact in patients with any solid tumor histology
Preliminary anti-tumor activity will be evaluated in up to approximately 102 evaluable patients in Part 2 with SY-1365 administered alone in combination with carboplatin or in combination with fulvestrant Part 2 will consist of five cohorts
Cohort 1 approximately 24 patients with advanced ovarian cancer with 3 previous lines of treatment Monotherapy
Cohort 2 approximately 24 patients with relapsed ovarian cancer with previous platinum therapy SY-1365 Carboplatin
Cohort 3 approximately 12 patients with clear cell ovarian cancer Monotherapy
Cohort 4 approximately 20-30 patients with biopsy-accessible advanced solid tumors of any histology Monotherapy
Cohort 5 approximately 12 patients with HR metastatic breast cancer post CDK46 hormonal therapy treatment SY-1365 fulvestrant
Overall the study may enroll up to approximately 137 evaluable patients across dose escalation Part 1 and expansion cohorts Part 2 Cohorts 1 2 3 4 and 5
Following the identification of a recommended dose and regimen from Part 1 the study entered Part 2 to further evaluate safety and the antitumor activity of SY-1365 in patients with select solid tumors and to confirm target engagement and downstream pathway impact in patients with any solid tumor histology
Preliminary anti-tumor activity will be evaluated in up to approximately 102 evaluable patients in Part 2 with SY-1365 administered alone in combination with carboplatin or in combination with fulvestrant Part 2 will consist of five cohorts
Cohort 1 approximately 24 patients with advanced ovarian cancer with 3 previous lines of treatment Monotherapy
Cohort 2 approximately 24 patients with relapsed ovarian cancer with previous platinum therapy SY-1365 Carboplatin
Cohort 3 approximately 12 patients with clear cell ovarian cancer Monotherapy
Cohort 4 approximately 20-30 patients with biopsy-accessible advanced solid tumors of any histology Monotherapy
Cohort 5 approximately 12 patients with HR metastatic breast cancer post CDK46 hormonal therapy treatment SY-1365 fulvestrant
Overall the study may enroll up to approximately 137 evaluable patients across dose escalation Part 1 and expansion cohorts Part 2 Cohorts 1 2 3 4 and 5
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