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

StatusCompleted
PhasePhase 2
Started

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Record History

The 50 most recent of 128 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Trial completed Show 6 more changesShow less
    • Study completion date changed from estimate of Jan 28, 2027 to Sep 14, 2026
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints: details revised at 3 of 4 entries
    • Study description revised
    • Site details revised at 5 of 31 sites
    • Publications: details revised at 1 of 1 entry
  2. 28 versions Re-verified since Mar 4, 2026, no change to tracked fieldsv100-v127
  3. Study completion date: Jan 28, 2026 to Jan 28, 2027v99
  4. Re-verified, no change to tracked fieldsv98
  5. Enrollment target: 19 to 17v97 Show 4 more changesShow less
    • Study completion date: Dec 9, 2025 to Jan 28, 2026
    • Study sites revised (31)
    • Study title expanded, about 7 words
    • Eligibility criteria expanded, about 2 words
Show 18 earlier versionsHide 18 earlier versions
  1. Results first posted: Jul 8, 2025
    • Secondary endpoints: details revised at 4 of 4 entries
    v96
  2. Enrollment target: 14 to 19v95 Show 4 more changesShow less
    • Secondary endpoints revised (4)
    • Primary endpoint revised
    • Study title shortened, about 7 words
    • Eligibility criteria shortened, about 2 words
  3. Study sites revised (31)v94
  4. Enrollment target: estimated 18 to confirmed 14
    • Study completion date: Jul 1, 2024 to Dec 9, 2025
    v93
  5. Study sites revised (31)v92
  6. 2 versions Re-verified since Mar 5, 2024, no change to tracked fieldsv90-v91
  7. Study sites revised (31)v89
  8. 2 versions Re-verified since Sep 23, 2023, no change to tracked fieldsv87-v88
  9. Primary and study completion dates: Jul 1, 2023 to Jul 1, 2024
    • Start date: Jun 30, 2020 to Nov 16, 2020
    v86
  10. 5 versions Re-verified since Dec 3, 2022, no change to tracked fieldsv81-v85
  11. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 31 of 31 sites
    v80
  12. Site details revised at 1 of 31 sitesv79
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03641313
Lead Sponsor National Cancer Institute (NCI)
Conditions
(from sponsor)		 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
Enrollment 17 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov