Vactosertib for Esophageal Cancer
Trial Summary
Will I have to stop taking my current medications?
The trial requires stopping certain medications that interact with vactosertib, specifically those that are strong CYP3A4 inhibitors or inducers, and some other drugs with narrow therapeutic indices. A washout period (time without taking certain medications) of 5 half-lives is recommended before starting the trial.
What is the purpose of this trial?
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.
Research Team
Sakti Chakrabarti, MD
Principal Investigator
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Eligibility Criteria
This trial is for adults with localized esophageal adenocarcinoma who haven't had prior treatments for this cancer. They must be fit enough for surgery, have normal liver and kidney function tests, acceptable blood counts, and an ECOG performance status of ≤2 (able to carry out light activity).Inclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Initial Treatment with Vactosertib
Participants take vactosertib orally, 200 mg twice daily for five days a week for 2 weeks
Chemoradiotherapy
Participants undergo standard of care chemoradiotherapy
Post-Chemoradiotherapy Treatment with Vactosertib
Participants take vactosertib for 4 weeks after standard of care chemoradiotherapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Vactosertib
Find a Clinic Near You
Who Is Running the Clinical Trial?
Jennifer Eva Selfridge, MD
Lead Sponsor
Sakti Chakrabarti
Lead Sponsor
Jennifer Eva Selfridge
Lead Sponsor