deltatrials
Completed PHASE1 INTERVENTIONAL 4-arm NCT01226316

Safety, Tolerability & Potential Anti-cancer Activity of Increasing Doses of AZD5363 in Different Treatment Schedules

A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of AZD5363 Under Adaptable Dosing Schedules in Patients With Advanced Solid Malignancies

Sponsor: AstraZeneca

Conditions AKT1 Advanced Solid Malignancy Advanced or Metastatic Breast Cancer Cervical Cancer ER Positive Endometrial Cancer HER2 Positive Ovarian Cancer PIK3CA PTEN Pharmacodynamics Pharmacokinetics Safety and Tolerability Tumour Response
Interventions AZD5363
Updated 38 times since 2017 Last updated: Jun 25, 2025 Started: Dec 1, 2010 Primary completion: Apr 26, 2019 Completion: Dec 3, 2024
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE1 trial investigates AKT1 and Advanced Solid Malignancy and is currently completed. AstraZeneca leads this study, which shows 38 recorded versions since 2010 — indicating substantial longitudinal coverage. As an oncology study, it adds to the longitudinal record of treatment development for this indication.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~May 2017 · 3 months · monthly snapshot~May 2017 – ~Oct 2017 · 5 months · monthly snapshot~Oct 2017 – ~Dec 2017 · 2 months · monthly snapshot~Dec 2017 – ~Feb 2018 · 2 months · monthly snapshot~Feb 2018 – ~Jun 2018 · 4 months · monthly snapshot~Jun 2018 – ~Jul 2018 · 30 days · monthly snapshot~Jul 2018 – ~Sep 2018 · 2 months · monthly snapshot~Sep 2018 – ~Oct 2018 · 30 days · monthly snapshot~Oct 2018 – ~Dec 2018 · 2 months · monthly snapshot~Dec 2018 – ~Feb 2019 · 2 months · monthly snapshot~Feb 2019 – ~Jul 2019 · 5 months · monthly snapshot~Jul 2019 – ~Oct 2019 · 3 months · monthly snapshot~Oct 2019 – ~Jan 2020 · 3 months · monthly snapshot~Jan 2020 – ~Apr 2020 · 3 months · monthly snapshot~Apr 2020 – ~Jul 2020 · 3 months · monthly snapshot~Jul 2020 – ~Oct 2020 · 3 months · monthly snapshot~Oct 2020 – ~Jan 2021 · 3 months · monthly snapshot~Jan 2021 – ~Apr 2021 · 3 months · monthly snapshot~Apr 2021 – ~Sep 2021 · 5 months · monthly snapshot~Sep 2021 – ~Nov 2021 · 2 months · monthly snapshot~Nov 2021 – ~Jan 2022 · 2 months · monthly snapshot~Jan 2022 – ~Apr 2022 · 3 months · monthly snapshot~Apr 2022 – ~Jul 2022 · 3 months · monthly snapshot~Jul 2022 – ~Sep 2022 · 2 months · monthly snapshot~Sep 2022 – ~Jan 2023 · 4 months · monthly snapshot~Jan 2023 – ~Apr 2023 · 3 months · monthly snapshot~Apr 2023 – ~Jul 2023 · 3 months · monthly snapshot~Jul 2023 – ~Nov 2023 · 4 months · monthly snapshot~Nov 2023 – ~Feb 2024 · 3 months · monthly snapshot~Feb 2024 – ~Jun 2024 · 4 months · monthly snapshot~Jun 2024 – ~Jul 2024 · 30 days · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Dec 2024 · 3 months · monthly snapshot~Dec 2024 – ~Jan 2025 · 31 days · monthly snapshot~Jan 2025 – ~Jul 2025 · 6 months · monthly snapshot~Jul 2025 – ~Sep 2025 · 2 months · monthly snapshot~Sep 2025 – present · 8 months · monthly snapshot

Change History

38 versions recorded

  1. Sep 2025 — Present [monthly]

    Completed PHASE1

  2. Jul 2025 — Sep 2025 [monthly]

    Completed PHASE1

  3. Jan 2025 — Jul 2025 [monthly]

    Completed PHASE1

    Status: Active Not Recruiting → Completed

  4. Dec 2024 — Jan 2025 [monthly]

    Active Not Recruiting PHASE1

  5. Sep 2024 — Dec 2024 [monthly]

    Active Not Recruiting PHASE1

▶ Show 33 earlier versions

  1. Jul 2024 — Sep 2024 [monthly]

    Active Not Recruiting PHASE1

  2. Jun 2024 — Jul 2024 [monthly]

    Active Not Recruiting PHASE1

  3. Feb 2024 — Jun 2024 [monthly]

    Active Not Recruiting PHASE1

  4. Nov 2023 — Feb 2024 [monthly]

    Active Not Recruiting PHASE1

  5. Jul 2023 — Nov 2023 [monthly]

    Active Not Recruiting PHASE1

  6. Apr 2023 — Jul 2023 [monthly]

    Active Not Recruiting PHASE1

  7. Jan 2023 — Apr 2023 [monthly]

    Active Not Recruiting PHASE1

  8. Sep 2022 — Jan 2023 [monthly]

    Active Not Recruiting PHASE1

  9. Jul 2022 — Sep 2022 [monthly]

    Active Not Recruiting PHASE1

  10. Apr 2022 — Jul 2022 [monthly]

    Active Not Recruiting PHASE1

  11. Jan 2022 — Apr 2022 [monthly]

    Active Not Recruiting PHASE1

  12. Nov 2021 — Jan 2022 [monthly]

    Active Not Recruiting PHASE1

  13. Sep 2021 — Nov 2021 [monthly]

    Active Not Recruiting PHASE1

  14. Apr 2021 — Sep 2021 [monthly]

    Active Not Recruiting PHASE1

  15. Jan 2021 — Apr 2021 [monthly]

    Active Not Recruiting PHASE1

  16. Oct 2020 — Jan 2021 [monthly]

    Active Not Recruiting PHASE1

  17. Jul 2020 — Oct 2020 [monthly]

    Active Not Recruiting PHASE1

  18. Apr 2020 — Jul 2020 [monthly]

    Active Not Recruiting PHASE1

  19. Jan 2020 — Apr 2020 [monthly]

    Active Not Recruiting PHASE1

  20. Oct 2019 — Jan 2020 [monthly]

    Active Not Recruiting PHASE1

  21. Jul 2019 — Oct 2019 [monthly]

    Active Not Recruiting PHASE1

  22. Feb 2019 — Jul 2019 [monthly]

    Active Not Recruiting PHASE1

    Status: Recruiting → Active Not Recruiting

  23. Dec 2018 — Feb 2019 [monthly]

    Recruiting PHASE1

  24. Oct 2018 — Dec 2018 [monthly]

    Recruiting PHASE1

  25. Sep 2018 — Oct 2018 [monthly]

    Recruiting PHASE1

  26. Jul 2018 — Sep 2018 [monthly]

    Recruiting PHASE1

  27. Jun 2018 — Jul 2018 [monthly]

    Recruiting PHASE1

  28. Feb 2018 — Jun 2018 [monthly]

    Recruiting PHASE1

  29. Dec 2017 — Feb 2018 [monthly]

    Recruiting PHASE1

  30. Oct 2017 — Dec 2017 [monthly]

    Recruiting PHASE1

  31. May 2017 — Oct 2017 [monthly]

    Recruiting PHASE1

  32. Feb 2017 — May 2017 [monthly]

    Recruiting PHASE1

  33. Jan 2017 — Feb 2017 [monthly]

    Recruiting PHASE1

    First recorded

Dec 2010

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • AstraZeneca
Data source: AstraZeneca

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Amsterdam, Netherlands , Aurora, United States , Boston, United States , Charleston, United States , Chūōku, Japan , Edmonton, Canada , Houston, United States , Kashiwa, Japan , København Ø, Denmark , Kōtoku, Japan and 22 more locations