Ignite Creation Date:
2024-05-06 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06178588
Status:
RECRUITING
Last Update Posted:
2024-02-22
First Post:
2023-12-09
Brief Title:
Sacituzumab Govitecan for the Treatment for Patients With Locally Advanced Recurrent or Metastatic Cholangiocarcinoma
Sponsor:
University of Kansas Medical Center
Organization:
University of Kansas Medical Center
Study Overview
Official Title:
A Phase II Open-Label Study of Sacituzumab Govitecan in Patients With Previously Treated Locally Advanced Recurrent or Metastatic Cholangiocarcinoma
Status:
RECRUITING
Status Verified Date:
2024-02
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 phase II trial tests how well sacituzumab govitecan works in treating patients with cholangiocarcinoma that has spread to nearby tissue or lymph nodes locally advanced that has come back after a period of improvement recurrent or that has spread from where it first started primary site to other places in the body metastatic Sacituzumab govitecan is a monoclonal antibody called hRS7 linked to a toxic agent called SN-38 HRS7 is a form of targeted therapy because it attaches to specific molecules receptors on the surface of tumor cells known as TROP2 receptors and delivers SN-38 to kill them
Detailed Description:
PRIMARY OBJECTIVE
I To determine anti-tumor activity by overall response rate ORR
SECONDARY OBJECTIVES
I To determine treatment safety based on toxicities participants who have received at least one dose of sacituzumab govitecan
II To determine anti-tumor activity by progression free survival PFS III To determine anti-tumor activity by disease control rate DCR IV To determine overall survival OS
EXPLORATORY OBJECTIVES
I To determine if treatment will result in reduction of the circulating tumor deoxyribonucleic acid DNA as a measure of therapeutic response
II To determine relationship between tumor mutational profile already performed as standard of care next generation sequencing NGS based test to response
OUTLINE
Patients receive sacituzumab govitecan intravenously IV over 1-3 hours on days 1 and 8 of each cycle Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity Patients undergo tumor biopsy positron emission tomography PETcomputed tomography CT or magnetic resonance imaging MRI scans and blood sample collection throughout the study
After completion of study treatment patients are followed up at 30 days and every 3 months for up to 24 months
I To determine anti-tumor activity by overall response rate ORR
SECONDARY OBJECTIVES
I To determine treatment safety based on toxicities participants who have received at least one dose of sacituzumab govitecan
II To determine anti-tumor activity by progression free survival PFS III To determine anti-tumor activity by disease control rate DCR IV To determine overall survival OS
EXPLORATORY OBJECTIVES
I To determine if treatment will result in reduction of the circulating tumor deoxyribonucleic acid DNA as a measure of therapeutic response
II To determine relationship between tumor mutational profile already performed as standard of care next generation sequencing NGS based test to response
OUTLINE
Patients receive sacituzumab govitecan intravenously IV over 1-3 hours on days 1 and 8 of each cycle Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity Patients undergo tumor biopsy positron emission tomography PETcomputed tomography CT or magnetic resonance imaging MRI scans and blood sample collection throughout the study
After completion of study treatment patients are followed up at 30 days and every 3 months for up to 24 months
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?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2023-09080 | REGISTRY | None | None |
| IIT-2023-SIGNA | None | None | None |
| STUDY00150700 | OTHER | None | None |
| P30CA168524 | NIH | University of Kansas Cancer Center | httpsreporternihgovquickSearchP30CA168524 |