Berzosertib and Irinotecan in Treating Patients With Progressive, Metastatic, or Unresectable TP53 Mutant Gastric or Gastroesophageal Junction Cancer
Public ClinicalTrials.gov record NCT03641313. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2 Single-Arm Study of M6620 in Combination With Irinotecan in Patients With Progressive TP53 Mutant Gastric and Gastro-Esophageal Junction Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03641313
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 17 participants
Conditions and interventions
Conditions
- Clinical Stage III Gastric Cancer AJCC v8
- Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8
- Clinical Stage IV Gastric Cancer AJCC v8
- Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8
- Metastatic Gastric Adenocarcinoma
- Metastatic Gastroesophageal Junction Adenocarcinoma
- Unresectable Gastric Adenocarcinoma
- Unresectable Gastroesophageal Junction Adenocarcinoma
Interventions
- Berzosertib Drug
- Computed Tomography Assisted Biopsy Procedure
- Endoscopic Biopsy Procedure
- Irinotecan Drug
- Magnetic Resonance Imaging Procedure
Drug · Procedure
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 16, 2020 (Actual)
- Primary completion
- Jul 1, 2024 (Actual)
- Completion
- Sep 14, 2026 (Actual)
- Last update posted
- Oct 20, 2026
2020 – 2026
United States locations
- U.S. sites
- 31
- U.S. states
- 10
- U.S. cities
- 28
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| City of Hope Comprehensive Cancer Center | Duarte | California | 91010 | — |
| Los Angeles General Medical Center | Los Angeles | California | 90033 | — |
| USC / Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | — |
| UC Irvine Health/Chao Family Comprehensive Cancer Center | Orange | California | 92868 | — |
| University of California Davis Comprehensive Cancer Center | Sacramento | California | 95817 | — |
| UM Sylvester Comprehensive Cancer Center at Coral Gables | Coral Gables | Florida | 33146 | — |
| UM Sylvester Comprehensive Cancer Center at Deerfield Beach | Deerfield Beach | Florida | 33442 | — |
| University of Miami Miller School of Medicine-Sylvester Cancer Center | Miami | Florida | 33136 | — |
| UM Sylvester Comprehensive Cancer Center at Kendall | Miami | Florida | 33176 | — |
| UM Sylvester Comprehensive Cancer Center at Plantation | Plantation | Florida | 33324 | — |
| Northwestern University | Chicago | Illinois | 60611 | — |
| University of Kansas Clinical Research Center | Fairway | Kansas | 66205 | — |
| HaysMed | Hays | Kansas | 67601 | — |
| Lawrence Memorial Hospital | Lawrence | Kansas | 66044 | — |
| The University of Kansas Cancer Center - Olathe | Olathe | Kansas | 66061 | — |
| University of Kansas Cancer Center-Overland Park | Overland Park | Kansas | 66210 | — |
| Mercy Hospital Pittsburg | Pittsburg | Kansas | 66762 | — |
| Salina Regional Health Center | Salina | Kansas | 67401 | — |
| University of Kansas Health System Saint Francis Campus | Topeka | Kansas | 66606 | — |
| University of Kansas Hospital-Westwood Cancer Center | Westwood | Kansas | 66205 | — |
| University Health Truman Medical Center | Kansas City | Missouri | 64108 | — |
| University of Kansas Cancer Center - North | Kansas City | Missouri | 64154 | — |
| University of Kansas Cancer Center - Lee's Summit | Lee's Summit | Missouri | 64064 | — |
| University of Kansas Cancer Center at North Kansas City Hospital | North Kansas City | Missouri | 64116 | — |
| Wake Forest University at Clemmons | Clemmons | North Carolina | 27012 | — |
| Wake Forest Baptist Health - Wilkes Medical Center | Wilkesboro | North Carolina | 28659 | — |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | — |
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | — |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | — |
| Vanderbilt University/Ingram Cancer Center | Nashville | Tennessee | 37232 | — |
| Huntsman Cancer Institute/University of Utah | Salt Lake City | Utah | 84112 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03641313, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Oct 20, 2026 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03641313 live on ClinicalTrials.gov.