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NCT04460937 · ClinicalTrials.gov registry record · Phase 1
Testing the Addition of an Anti-cancer Drug, Adavosertib, to Radiation Therapy for Patients With Incurable Esophageal and Gastroesophageal Junction Cancers
A Phase 1 study of Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 and Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 1
- Development phase
- 4
- Enrollment target
- 7
- Study locations
NCT04460937: Active Phase 1 study of Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 and Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8, sponsored by National Cancer Institute (NCI).
NCT04460937 is a Phase 1 study of Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 and Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8 that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 4 participants, below the 98-participant average among 19 other Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 trials with a reported enrollment target (96% lower). The trial reports 7 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04460937, a Phase 1 study of Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 and Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 4 participants
- Enrollment target
- 7
- Study locations
Study 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.
Primary Outcome
Planned analysis for the MTD was to employ a BOIN design where the target toxicity rate for the MTD is 25% with 75% dose-elimination cut-off. Due to the study ending early and low enrollment numbers, analysis of MTD was unable to be performed. The data presented is the maximum dose that was reached in the dose-escalation.
Conditions Studied
Interventions
- RADIATION Radiation Therapy
- DRUG Adavosertib
Study Locations (7)
Utah
- University of Utah Sugarhouse Health Center - Salt Lake City
- Huntsman Cancer Institute/University of Utah - Salt Lake City
California
- City of Hope Comprehensive Cancer Center - Duarte
Illinois
- Northwestern University - Chicago
Kentucky
- University of Kentucky/Markey Cancer Center - Lexington
Ohio
- Ohio State University Comprehensive Cancer Center - Columbus
Pennsylvania
- University of Pittsburgh Cancer Institute (UPCI) - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2021-04-09 |
| Est. Completion | 2025-12-18 |
| Phase | Phase 1 |
What the registry record for NCT04460937 still lists
NCT04460937 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 98-participant average among 19 other Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 trials with a reported enrollment target (96% lower).
The record links to 10 conditions, with Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 appearing as the primary indexed condition, and to 2 interventions - of which Radiation Therapy is the first listed.
NCT04460937 lists 7 locations in 6 states (Utah, California, Illinois).
Frequently Asked Questions
What is clinical trial NCT04460937 about?
NCT04460937 is a clinical study titled "Testing the Addition of an Anti-cancer Drug, Adavosertib, to Radiation Therapy for Patients With Incurable Esophageal and Gastroesophageal Junction Cancers". 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 sto...
What is the current status of trial NCT04460937?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 4 participants. The study started on 2021-04-09. Estimated completion is 2025-12-18.
What conditions does trial NCT04460937 study?
This clinical trial studies the following conditions: Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8, Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8, Clinical Stage III Esophageal Adenocarcinoma AJCC v8, Clinical Stage IV Esophageal Adenocarcinoma AJCC v8, Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8.
What interventions are being tested in trial NCT04460937?
The interventions under investigation include: Radiation Therapy (RADIATION), Adavosertib (DRUG).
Who is sponsoring clinical trial NCT04460937?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04460937 being conducted?
This trial has 7 study locations across California, Illinois, Kentucky, Ohio, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04460937's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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