Vactosertib for Esophageal Cancer

Overseen By Sakti Chakrabarti, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Jennifer Eva Selfridge, MD

Must not be taking: CYP3A4 inhibitors, CYP3A4 inducers

Disqualifiers: Active malignancy, Uncontrolled illness, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

25 Participants Needed

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

I have not had chemo, immunotherapy, or radiation for this cancer (except for treatments targeting Barrett's metaplasia).

I can take care of myself but might not be able to do heavy physical work.

My bilirubin levels are below 2 mg/dl, or below 3 mg/dl if I have Gilbert syndrome.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Treatment with Vactosertib

Participants take vactosertib orally, 200 mg twice daily for five days a week for 2 weeks

2 weeks

1 visit (in-person) for PET CT scan and endoscopy with biopsy

Chemoradiotherapy

Participants undergo standard of care chemoradiotherapy

6 weeks

Post-Chemoradiotherapy Treatment with Vactosertib

Participants take vactosertib for 4 weeks after standard of care chemoradiotherapy

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

Treatment Details

Interventions

• Vactosertib

Trial Overview The study tests if a pill called vactosertib can improve outcomes when taken before and after standard chemoradiation therapy in esophageal cancer patients. The effects are monitored using PET CT scans and biopsies.

Participant Groups

Group I: Vactosertib + Chemoradiotherapy Experimental Treatment 3 Interventions

Vactosertib orally, 200 mg twice daily for five days a week for 2 weeks, followed by standard of care chemoradiotherapy, followed by Vactosertib for 4 weeks after standard of care chemoradiotherapy

Who Is Running the Clinical Trial?

Jennifer Eva Selfridge, MD

Lead Sponsor

Trials

2

Recruited

40+

Sakti Chakrabarti

Lead Sponsor

Trials

1

Recruited

30+

Jennifer Eva Selfridge

Lead Sponsor

Trials

2

Recruited

40+