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ACTIVE NOT RECRUITING Phase 2

Berzosertib and Irinotecan in Treating Patients With Progressive, Metastatic, or Unresectable TP53 Mutant Gastric or Gastroesophageal Junction Cancer

NCT03641313 · View on ClinicalTrials.gov ↗

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.

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

Sponsor

National Cancer Institute (NCI)

2,390 total trials

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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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 2,390 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03641313 reports 20 study locations spanning 4 distinct geographic areas — top geographies include Kansas, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03641313?

This trial is sponsored by National Cancer Institute (NCI), which has 2,390 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial