Testing the Addition of a New Anti-cancer Drug, M3814 (Peposertib), to the Usual Radiotherapy in Patients With Locally Advanced Pancreatic Cancer

StatusSuspended
PhasePhase 1/2
Started

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Record History

The 50 most recent of 240 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Recruitment suspended Sponsor's reason: Other - DSMB decision
    • Site details revised at 44 of 44 sites
  2. Secondary endpoints: details revised at 4 of 6 entries
    • Site details revised at 9 of 44 sites
    • Eligibility criteria expanded, about 1 word
  3. Site details revised at 1 of 44 sitesv238
  4. Site details revised at 1 of 44 sitesv237
  5. Study sites revised (44)v236
  6. Study sites revised (44)v235
  7. Primary and study completion pushed from Aug 1, 2026 to Aug 1, 2027v234
  8. Site details revised at 1 of 44 sitesv233
  9. 2 versions Re-verified since Jun 10, 2026, no change to tracked fieldsv231-v232
  10. Site details revised at 1 of 44 sitesv230
  11. Site details revised at 2 of 44 sitesv229
  12. Site details revised at 1 of 44 sitesv228
  13. Site details revised at 1 of 44 sitesv227
  14. 8 versions Re-verified since Apr 1, 2026, no change to tracked fieldsv219-v226
  15. Site details revised at 2 of 44 sitesv218
  16. 21 versions Re-verified since Feb 27, 2026, no change to tracked fieldsv197-v217
  17. Site details revised at 1 of 44 sitesv196
  18. 2 versions Re-verified since Feb 24, 2026, no change to tracked fieldsv194-v195
  19. Site details revised at 1 of 44 sitesv193
  20. 2 versions Re-verified since Feb 19, 2026, no change to tracked fieldsv191-v192
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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 I/II trial studies the safety, side effects and best dose of M3814 and to see how well it works when given together with radiation therapy in treating patients with pancreatic cancer that has spread to nearby tissue or lymph nodes (locally advanced). M3814 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Giving M3814 and hypofractionated radiation therapy together may be safe, tolerable and/or more effective than radiation therapy alone in treating patients with locally advanced pancreatic cancer.
Trial Details
NCT Number NCT04172532
Lead Sponsor National Cancer Institute (NCI)
Conditions
(from sponsor)		 Locally Advanced Pancreatic Adenocarcinoma, Stage III Pancreatic Cancer AJCC v8
Related terms Pancreatic Neoplasms
Enrollment 92 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov