Ignite Creation Date:
2024-05-06 @ 7:31 PM
Last Modification Date:
2024-10-26 @ 3:08 PM
Study NCT ID:
NCT06044311
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-13
First Post:
2023-09-07
Brief Title:
Oral TGF-beta Receptor I Inhibitor Vactosertib in SOC Chemoradiotherapy for Esophageal Adenocarcinoma
Sponsor:
Jennifer Eva Selfridge
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
A Window of Opportunity Trial Evaluating the Oral TGF-beta Receptor I Inhibitor Vactosertib in Patients Undergoing Standard of Care Chemoradiotherapy for Locally Advanced Esophageal Adenocarcinoma
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
This interventional clinical trial aims to find ways of improving treatments for individuals with esophageal cancer Laboratory-based studies show that using medicines that affect a protein called TGF-beta TGFβ can kill esophageal cancer cells in individuals who have localized esophageal adenocarcinoma and are being considered for standard-of-care chemoradiation prior to surgery Participants of this study will take a pill called vactosertib for two weeks before starting standard of care chemoradiation At the end of the two weeks of taking vactosertib participants will have a Positron Emission Tomography Computer Assisted Tomography PET CT scan and undergo an endoscopy with a biopsy to determine if the vactosertib is working After chemoradiation participants will take vactosertib again for four weeks and then be considered for surgery
Detailed Description:
Esophageal adenocarcinoma EAC is an aggressive malignancy with limited effective treatment options In localized EAC clinical stages II and III the standard of care is pre-operative concurrent chemoradiation CRT followed by surgical resection which results in pathologic complete response pCR in approximately 20 of participants but with high rates of post-operative recurrence It was recently discovered that EACs are driven by signaling through TGFβ Receptor I TGFβRI and in vivo models of EAC show tumor reduction by targeting this pathway with a novel small molecule inhibitor of TGFβRI called vactosertib In this study participants who have locally advanced EAC will be treated with vactosertib before and after standard of care chemoradiation to take advantage of natural windows of opportunity during which participants are being planned for their standard of care treatments
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