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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04460937
Other study ID # NCI-2020-04698
Secondary ID NCI-2020-0469810
Status Active, not recruiting
Phase Phase 1
First received
Last updated
Start date April 9, 2021
Est. completion date October 31, 2024

Study information

Verified date April 2024
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


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Study Design


Related Conditions & MeSH terms

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Intervention

Drug:
Adavosertib
Given PO
Radiation:
Radiation Therapy
Undergo radiation therapy

Locations

Country Name City State
United States Northwestern University Chicago Illinois
United States Ohio State University Comprehensive Cancer Center Columbus Ohio
United States City of Hope Comprehensive Cancer Center Duarte California
United States University of Kentucky/Markey Cancer Center Lexington Kentucky
United States University of Pittsburgh Cancer Institute (UPCI) Pittsburgh Pennsylvania
United States Huntsman Cancer Institute/University of Utah Salt Lake City Utah
United States University of Utah Sugarhouse Health Center Salt Lake City Utah

Sponsors (1)

Lead Sponsor Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Maximum tolerated dose (MTD) Will employ a BOIN design where the target toxicity rate for the MTD is 25% with 75% dose-elimination cut-off. After completion of treatment
Primary Incidence of adverse events Frequency and severity of adverse events and tolerability of the regimen will be collected and summarized with descriptive statistics. The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns. Up to 5 years
Secondary Symptom relief rate Will be calculated with 95% binomial confidence intervals. After completion of treatment
Secondary Time to second intervention for dysphagia Patient dysphagia will be evaluated using the Ogilvie dysphagia score, comparing pre-treatment to post-treatment scores The time from initiation of therapy to the time of second intervention for dysphagia, assessed up to 5 years
Secondary Overall survival Survival will initially be analyzed using Kaplan-Meier methods, resulting in median survival times with 95% confidence interval (CI). From date of patient enrollment to death due to any cause, assessed up to 5 years after completion of treatment
Secondary Ogilvie dysphagia scores The scores will be summarized and compared using paired t-test or Wilcoxon signed-rank test. Patient dysphagia will be evaluated using the Ogilvie dysphagia score, comparing pre-treatment to post-treatment scores. At baseline and after completion of treatment
Secondary Biomarkers Will be described graphically or summary measures (e.g. mean and standard errors, or median and range) and compared between responders and non-responders using a two sample t-test or Wilcoxon test if the data is not normally distributed. Up to 5 years
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