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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: Active 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).

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Number of patients that achieved either a partial response or complete response as measured by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 response criteria. Per RECIST v.1.1 assessed by CT or MRI: complete response (CR) is disappearance of all target lesions; partial response (PR) is \>=30% decrease in the sum of the longest diameter of target lesions; Overall response (OR) = CR + PR.

Conditions Studied

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 Metastatic Gastric Adenocarcinoma Unresectable Gastric Adenocarcinoma Unresectable Gastroesophageal Junction Adenocarcinoma

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

FieldValue
Enrollment Target 17 participants
Start Date 2020-11-16
Est. Completion 2027-01-28
Phase Phase 2
National Cancer Institute (NCI)

3,257 total trials

What the registry record for NCT03641313 still lists

NCT03641313 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, 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 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 names 20 study sites across 4 states, led by 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.

Learn More About Clinical Trials

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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03641313's enrollment target sits among peer trials

17 14th of 19 higher than 6 of 19 other Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8 trials

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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT03641313, the US trial registry maintained by the National Library of Medicine. NCT03641313 (small enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.