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NCT03641313 · ClinicalTrials.gov registry record · Phase 2
Berzosertib and Irinotecan in Treating Patients With Progressive, Metastatic, or Unresectable TP53 Mutant Gastric or Gastroesophageal Junction Cancer
A Phase 2 study of Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 and Clinical Stage IV Gastric Cancer AJCC v8, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 2
- Development phase
- 17
- Enrollment target
- 20
- Study locations
NCT03641313 is a Phase 2 study of Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 and Clinical Stage IV Gastric Cancer AJCC v8 that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 17 participants, below the 97-participant average among 19 other Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 trials with a reported enrollment target (82% lower). The trial reports 20 study locations across 4 states.
The verdict
NCT03641313, a Phase 2 study of Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 and Clinical Stage IV Gastric Cancer AJCC v8, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 17 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase II trial studies the how well berzosertib and irinotecan work in treating patients with gastric or gastroesophageal junction cancer that is growing, spreading or getting worse (progressive), has spread to other places in the body (metastatic), or cannot be removed by surgery (unresectable). Berzosertib may stop the growth of tumor cells by blocking some of the enzymes needed for growth. Chemotherapy drugs, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving berzosertib and irinotecan may work better than irinotecan alone in treating patients with gastric and gastroesophageal junction cancer.
Conditions Studied
Interventions
- PROCEDURE Magnetic Resonance Imaging
- DRUG Irinotecan
- DRUG Berzosertib
- PROCEDURE Computed Tomography Assisted Biopsy
- PROCEDURE Endoscopic Biopsy
Study Locations (20)
Kansas
- University of Kansas Clinical Research Center - Fairway
- HaysMed - Hays
- Lawrence Memorial Hospital - Lawrence
- The University of Kansas Cancer Center - Olathe - Olathe
- University of Kansas Cancer Center-Overland Park - Overland Park
- Mercy Hospital Pittsburg - Pittsburg
- Salina Regional Health Center - Salina
- University of Kansas Health System Saint Francis Campus - Topeka
- University of Kansas Hospital-Westwood Cancer Center - Westwood
California
- City of Hope Comprehensive Cancer Center - Duarte
- Los Angeles General Medical Center - Los Angeles
- USC / Norris Comprehensive Cancer Center - Los Angeles
- UC Irvine Health/Chao Family Comprehensive Cancer Center - Orange
- University of California Davis Comprehensive Cancer Center - Sacramento
Florida
- UM Sylvester Comprehensive Cancer Center at Coral Gables - Coral Gables
- UM Sylvester Comprehensive Cancer Center at Deerfield Beach - Deerfield Beach
- University of Miami Miller School of Medicine-Sylvester Cancer Center - Miami
- UM Sylvester Comprehensive Cancer Center at Kendall - Miami
- UM Sylvester Comprehensive Cancer Center at Plantation - Plantation
Illinois
- Northwestern University - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2020-11-16 |
| Est. Completion | 2027-01-28 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03641313
The ClinicalTrials.gov registry entry for NCT03641313 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 97-participant average among 19 other Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 trials with a reported enrollment target (82% lower). The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 8 conditions, with Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Magnetic Resonance Imaging is the first listed.
NCT03641313 reports 20 study locations spanning 4 distinct geographic areas - top geographies include Kansas, California, Florida.
Frequently Asked Questions
What is clinical trial NCT03641313 about?
NCT03641313 is a clinical study titled "Berzosertib and Irinotecan in Treating Patients With Progressive, Metastatic, or Unresectable TP53 Mutant Gastric or Gastroesophageal Junction Cancer". This phase II trial studies the how well berzosertib and irinotecan work in treating patients with gastric or gastroesophageal junction cancer that is growing, spreading or getting worse (progressive), has spread to other places in the body (metastatic), or cannot be removed by surgery (unresectable...
What is the current status of trial NCT03641313?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 17 participants. The study started on 2020-11-16. Estimated completion is 2027-01-28.
What conditions does trial NCT03641313 study?
This clinical trial studies the following conditions: Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8, Clinical Stage IV Gastric Cancer AJCC v8, Clinical Stage III Gastric Cancer AJCC v8, Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8, Metastatic Gastroesophageal Junction Adenocarcinoma.
What interventions are being tested in trial NCT03641313?
The interventions under investigation include: Magnetic Resonance Imaging (PROCEDURE), Irinotecan (DRUG), Berzosertib (DRUG), Computed Tomography Assisted Biopsy (PROCEDURE), Endoscopic Biopsy (PROCEDURE).
Who is sponsoring clinical trial NCT03641313?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03641313 being conducted?
This trial has 20 study locations across California, Florida, Illinois, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8
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Clinical Stage IV Gastric Cancer AJCC v8
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