A Study to Assess the Safety and Tolerability of AZD1390 Given With Radiation Therapy in Patients With Brain Cancer

StatusCompleted
PhasePhase 1
Started

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Record History

The 50 most recent of 75 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Trial completed Show 4 more changesShow less
    • Primary and study completion dates changed from estimate of Sep 3, 2026 to Aug 31, 2026
    • Eligibility criteria expanded, about 39 words
    • Secondary endpoints: details revised at 1 of 9 entries
    • Study description expanded, about 3 words
  2. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 180 to confirmed 159
    • Study sites: 12 to 11
    • Primary and study completion dates: Sep 16, 2026 to Sep 3, 2026
    v74
  3. Site details revised at 3 of 12 sitesv73
  4. Re-verified, no change to tracked fieldsv72
  5. Interventions: AZD1390 (Drug), Radiation Therapy (Radiation) to AZD1390 (Drug), AZD1390 (Drug), AZD1390 (Drug), Radiation Therapy (Radiation), Radiation Therapy (Radiation), Radiation Therapy (Radiation)v71 Show 4 more changesShow less
    • Eligibility criteria shortened, about 8 words
    • Secondary endpoints: 10 to 9
    • Study description expanded, about 6 words
    • Study arms: 1 to 3
Show 45 earlier versionsHide 45 earlier versions
  1. Site details revised at 2 of 12 sitesv70
  2. 2 versions Re-verified since Jan 15, 2025, no change to tracked fieldsv68-v69
  3. Site details revised at 1 of 12 sitesv67
  4. Enrollment target: 120 to 180
    • Primary and study completion dates: Apr 22, 2026 to Sep 16, 2026
    • Secondary endpoints: 12 to 10
    • Site details revised at 1 of 12 sites
    v66
  5. Site details revised at 1 of 12 sitesv65
  6. Re-verified, no change to tracked fieldsv64
  7. Study sites: 9 to 12
    • Eligibility criteria expanded, about 49 words
    • Study description expanded, about 25 words
    v63
  8. Re-verified, no change to tracked fieldsv62
  9. Primary and study completion dates: Feb 28, 2025 to Apr 22, 2026v61
  10. Re-verified, no change to tracked fieldsv60
  11. Primary and study completion dates: Dec 1, 2026 to Feb 28, 2025
    • Site details revised at 1 of 9 sites
    v59
  12. Primary and study completion dates: Dec 30, 2024 to Dec 1, 2026
    • Site details revised at 1 of 9 sites
    v58
  13. Primary and study completion dates: Sep 30, 2024 to Dec 30, 2024v57
  14. Primary and study completion dates: Aug 9, 2024 to Sep 30, 2024v56
  15. 4 versions Re-verified since Jan 16, 2023, no change to tracked fieldsv52-v55
  16. Primary and study completion dates: May 9, 2024 to Aug 9, 2024v51
  17. Re-verified, no change to tracked fieldsv50
  18. Site details revised at 1 of 9 sitesv49
  19. Re-verified, no change to tracked fieldsv48
  20. Study sites: 8 to 9v47
  21. 2 versions Re-verified since May 16, 2022, no change to tracked fieldsv45-v46
  22. Primary and study completion dates: Mar 26, 2024 to May 9, 2024v44
  23. 3 versions Re-verified since Jan 14, 2022, no change to tracked fieldsv41-v43
  24. Primary and study completion dates: Dec 14, 2023 to Mar 26, 2024v40
  25. Re-verified, no change to tracked fieldsv39
  26. Eligibility criteria expanded, about 111 words
    • Secondary endpoints: 8 to 12
    • Site details revised at 1 of 8 sites
    v38
  27. Enrollment target: 132 to 120v37
  28. Primary and study completion dates: Nov 8, 2023 to Dec 14, 2023v36
  29. Re-verified, no change to tracked fieldsv35
  30. Primary and study completion dates: Feb 17, 2023 to Nov 8, 2023v34
  31. 2 versions Re-verified since Mar 5, 2021, no change to tracked fieldsv32-v33
  32. Primary and study completion dates: Jul 7, 2022 to Feb 17, 2023
    • Eligibility criteria expanded, about 18 words
    • Secondary endpoints revised (8)
    • Study description expanded, about 7 words
    v31
  33. Re-verified, no change to tracked fieldsv30
  34. Start date: Sep 20, 2015 to Apr 2, 2018
    • Enrollment target: 100 to 132
    v29
  35. Enrollment target: 132 to 100v28
  36. Start date: Apr 2, 2018 to Sep 20, 2015v27
  37. Re-verified, no change to tracked fieldsv26
  • 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.
AstraZeneca
729 trials monitored
See 62 trials at risk
Glioma
1,253 trials monitored
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Glioblastoma
711 trials monitored
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This study will test an investigational drug called AZD1390 in combination with radiation therapy for the treatment of brain tumors. This is the first time AZD1390 is being given to patients. This study will test safety, tolerability and PK (how the drug is absorbed, distributed and eliminated) of ascending doses of AZD1390 in combination with distinct regimens of radiation therapy
Trial Details
NCT Number NCT03423628
Lead Sponsor AstraZeneca
Conditions
(from sponsor)		 Recurrent Glioblastoma Multiforme, Primary Glioblastoma Multiforme, Brain Neoplasms, Malignant, Leptomeningeal Disease (LMD)
Related terms Brain Neoplasms, Glioblastoma, Hereditary Sensory and Autonomic Neuropathies, Inhibition, Psychological, Meningeal Neoplasms
Enrollment 159 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov