Adavosertib + Radiation for Esophageal Cancer

Recruiting at 6 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: National Cancer Institute (NCI)

No Placebo Group

Trial Summary

What is the purpose of this trial?

This phase I trial investigates the side effects and best dose of adavosertib and how well it works when given in combination with radiation therapy in treating patients with esophageal or gastroesophageal junction cancer for which no treatment is currently available (incurable). Adavosertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving adavosertib together with radiation therapy kill more tumor cells than radiation therapy alone in treating patients with esophageal and gastroesophageal junction cancer.

Research Team

Eric D. Miller

Principal Investigator

Ohio State University Comprehensive Cancer Center LAO

Eligibility Criteria

Adults with inoperable esophageal or gastroesophageal junction cancer, including squamous cell or adenocarcinoma, that is not eligible for definitive chemoradiation. Participants must have proper liver and kidney function, no severe heart conditions, be able to swallow capsules, and have a life expectancy over 3 months. Pregnant women are excluded.

Inclusion Criteria

My recent ECG shows no significant heart issues.

I have another cancer type, but it won't affect this trial's treatment.

My hepatitis B is under control with treatment.

Exclusion Criteria

I don't have long QT syndrome, a history of Torsades de pointes, recent heart attack, or ventricular arrhythmias.

I've had radiation therapy in my chest or belly area that might overlap with new treatment areas.

I am not pregnant or breastfeeding.

Treatment Details

Interventions

• Adavosertib (ATR Kinase Inhibitor)
• Radiation Therapy (Radiation)

Trial Overview The trial tests the safety and optimal dosage of Adavosertib combined with radiation therapy on patients with incurable esophageal or gastroesophageal junction cancers. The goal is to see if this combination is more effective than radiation alone in stopping tumor growth.

Participant Groups

Group I: Treatment (radiation therapy, adavosertib) Experimental Treatment 2 Interventions

Patients undergo radiation therapy QD 5 days per week for 3 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive adavosertib PO QD for 2-5 days (depending on dose level) during weeks 1 and 3 of radiation therapy in the absence of disease progression or unacceptable toxicity.

Who Is Running the Clinical Trial?

National Cancer Institute (NCI)

Lead Sponsor

Trials

14,080

Recruited

41,180,000+