Ignite Creation Date:
2024-05-06 @ 4:18 PM
Last Modification Date:
2024-10-26 @ 2:07 PM
Study NCT ID:
NCT04942054
Status:
TERMINATED
Last Update Posted:
2023-05-22
First Post:
2021-06-11
Brief Title:
A Study in Patients With Advanced Breast Cancer
Sponsor:
Sun Pharma Advanced Research Company Limited
Organization:
Sun Pharma Advanced Research Company Limited
Study Overview
Official Title:
A Phase 1 Study to Determine Safety Tolerability Pharmacokinetics Pharmacodynamics and Preliminary Efficacy of SCO-120 in Hormone Receptor Positive HER-2 Negative Advanced Breast Cancer Patients
Status:
TERMINATED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The decision to close is due commercial reasons only
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A Phase 1 Open label Dose escalation and Dose expansion study of SCO-120 in HR ve HER2-ve advanced metastatic breast cancer MBC patients to evalaute the safety tolerability and prelimnary efficacy Initial part with dose escalation is to determine the MTD and RP2D and PK and PD characterisation RP2D will be further evalauted for prelimnary efficacy in MBC patients with tretament failure on Aromatase InhibitorFulvestrantCDK4-6 inhibitors with or with out ESR1 mutation
Detailed Description:
Part 1 2 Approximately 51 subjects will be enrolled Part 3 Approximately 90 subjects will be enrolled
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