Ignite Creation Date:
2025-12-25 @ 4:08 AM
Ignite Modification Date:
2025-12-26 @ 3:05 AM
Study NCT ID:
NCT05884320
Status:
RECRUITING
Last Update Posted:
2025-10-09
First Post:
2023-05-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phase II Trial of Sacituzumab Govitecan in Recurrent and/or Metastatic Secretory Gland Cancers
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Phase II Trial of Sacituzumab Govitecan in Recurrent and/or Metastatic Secretory Gland Cancers
Status:
RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To learn if sacituzumab govitecan can help to control salivary gland cancer.
Detailed Description:
Primary Objectives:
* To assess the efficacy of SG in patients with R/M secretory gland carcinomas, specifically ACC (cohort 1) and SDC, adeno-NOS, and MEC (cohort 2)
Secondary Objectives:
* To estimate the median duration of response (DOR)
* To estimate the median progression-free survival (PFS)
* To estimate the median overall survival (OS)
* To assess safety of SG
Tertiary / Exploratory Objectives:
* To explore biomarkers that may predict response to therapy
* To assess the efficacy of SG in patients with R/M secretory gland carcinomas, specifically ACC (cohort 1) and SDC, adeno-NOS, and MEC (cohort 2)
Secondary Objectives:
* To estimate the median duration of response (DOR)
* To estimate the median progression-free survival (PFS)
* To estimate the median overall survival (OS)
* To assess safety of SG
Tertiary / Exploratory Objectives:
* To explore biomarkers that may predict response to therapy
Study Oversight
Has Oversight DMC:
True
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2023-04260 | OTHER | NCI-CTRP Clinical Trials Registry | View |