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Active Not RecruitingNCT04460937

Testing the Addition of an Anti-cancer Drug, Adavosertib, to Radiation Therapy for Patients With Incurable Esophageal and Gastroesophageal Junction Cancers

A Phase 1 Trial Combining WEE1 Inhibitor Adavosertib (AZD1775) With Radiation Therapy for Metastatic or Inoperable and Ineligible for Definitive Chemoradiation Esophageal and Gastroesophageal Junction Cancer

Status
Active Not Recruiting
Phase
Phase 1
Study type
Interventional
Enrollment
4 (actual)
Sponsor
National Cancer Institute (NCI) · NIH
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

Detailed description

PRIMARY OBJECTIVE: I. To identify the maximally tolerated dose of adavosertib (AZD1775) to be used in combination with radiation therapy for patients with esophageal/gastroesophageal junction (GEJ) cancer that is metastatic or inoperable and not eligible for definitive chemoradiation. SECONDARY OBJECTIVES: I. To observe and record anti-tumor activity. II. To evaluate the efficacy of AZD1775 when administered in combination with radiation therapy by assessing changes in Ogilvie dysphagia score following treatment, time to second intervention for dysphagia, and overall survival. III. To identify biomarkers that are predictive for response to experimental therapy. OUTLINE: This is a dose escalation study of adavosertib. Patients undergo radiation therapy once daily (QD) 5 days per week for 3 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive adavosertib orally (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. After completion of study treatment, patients are followed up at 3 weeks, every 3 months for 2 years, then every 6 months for 3 years.

Conditions

Interventions

TypeNameDescription
DRUGAdavosertibGiven PO
RADIATIONRadiation TherapyUndergo radiation therapy

Timeline

Start date
2021-04-09
Primary completion
2024-03-29
Completion
2025-12-18
First posted
2020-07-08
Last updated
2025-07-08
Results posted
2025-06-08

Locations

7 sites across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT04460937. Inclusion in this directory is not an endorsement.