deltatrials
Completed PHASE1 INTERVENTIONAL 1-arm NCT02197247

Study to Assess the Effect of Rifampicin on Blood Levels and Safety of AZD9291, in Patients With EGFRm+ NSCLC

A Phase I, Open-Label, Non-Randomised, Multicentre Study to Assess the Effect of Rifampicin (a CYP3A4 Inducer) on the Pharmacokinetics of AZD9291 in Patients With EGFRm Positive NSCLC Whose Disease Has Progressed on an EGFR TKI

Sponsor: AstraZeneca

Conditions Non Small Cell Lung Cancer
Interventions AZD9291 tablet dosing Pharmacokinetic sampling - AZ5140 and AZ7550 Pharmacokinetic sampling - AZD9291 Pharmacokinetic sampling - rifampicin Rifampicin
Updated 23 times since 2017 Last updated: Jun 18, 2021 Started: Dec 4, 2014 Primary completion: Jul 9, 2015 Completion: May 26, 2021
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT02197247, this PHASE1 trial focuses on Non Small Cell Lung Cancer and remains completed. Sponsored by AstraZeneca, it has been updated 23 times since 2014, reflecting substantial change activity. This study contributes to the evolving evidence base for cancer treatment protocols.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Jul 2017 · 5 months · monthly snapshot~Jul 2017 – ~Oct 2017 · 3 months · monthly snapshot~Oct 2017 – ~Jun 2018 · 8 months · monthly snapshot~Jun 2018 – ~Jul 2018 · 30 days · monthly snapshot~Jul 2018 – ~Nov 2018 · 4 months · monthly snapshot~Nov 2018 – ~Mar 2019 · 4 months · monthly snapshot~Mar 2019 – ~Jun 2019 · 3 months · monthly snapshot~Jun 2019 – ~Aug 2019 · 2 months · monthly snapshot~Aug 2019 – ~Dec 2019 · 4 months · monthly snapshot~Dec 2019 – ~Feb 2020 · 2 months · monthly snapshot~Feb 2020 – ~Apr 2020 · 2 months · monthly snapshot~Apr 2020 – ~Jul 2020 · 3 months · monthly snapshot~Jul 2020 – ~Oct 2020 · 3 months · monthly snapshot~Oct 2020 – ~Dec 2020 · 2 months · monthly snapshot~Dec 2020 – ~Jan 2021 · 31 days · monthly snapshot~Jan 2021 – ~May 2021 · 4 months · monthly snapshot~May 2021 – ~Sep 2021 · 4 months · monthly snapshot~Sep 2021 – ~Dec 2021 · 3 months · monthly snapshot~Dec 2021 – ~Jul 2024 · 31 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshot~Sep 2025 – present · 10 months · monthly snapshot

Change History

23 versions recorded

  1. Sep 2025 — Present [monthly]

    Completed PHASE1

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE1

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE1

  4. Dec 2021 — Jul 2024 [monthly]

    Completed PHASE1

  5. Sep 2021 — Dec 2021 [monthly]

    Completed PHASE1

    Status: Active Not Recruiting → Completed

▶ Show 18 earlier versions

  1. May 2021 — Sep 2021 [monthly]

    Active Not Recruiting PHASE1

  2. Jan 2021 — May 2021 [monthly]

    Active Not Recruiting PHASE1

  3. Dec 2020 — Jan 2021 [monthly]

    Active Not Recruiting PHASE1

  4. Oct 2020 — Dec 2020 [monthly]

    Active Not Recruiting PHASE1

  5. Jul 2020 — Oct 2020 [monthly]

    Active Not Recruiting PHASE1

  6. Apr 2020 — Jul 2020 [monthly]

    Active Not Recruiting PHASE1

  7. Feb 2020 — Apr 2020 [monthly]

    Active Not Recruiting PHASE1

  8. Dec 2019 — Feb 2020 [monthly]

    Active Not Recruiting PHASE1

  9. Aug 2019 — Dec 2019 [monthly]

    Active Not Recruiting PHASE1

  10. Jun 2019 — Aug 2019 [monthly]

    Active Not Recruiting PHASE1

  11. Mar 2019 — Jun 2019 [monthly]

    Active Not Recruiting PHASE1

  12. Nov 2018 — Mar 2019 [monthly]

    Active Not Recruiting PHASE1

  13. Jul 2018 — Nov 2018 [monthly]

    Active Not Recruiting PHASE1

  14. Jun 2018 — Jul 2018 [monthly]

    Active Not Recruiting PHASE1

  15. Oct 2017 — Jun 2018 [monthly]

    Active Not Recruiting PHASE1

  16. Jul 2017 — Oct 2017 [monthly]

    Active Not Recruiting PHASE1

  17. Feb 2017 — Jul 2017 [monthly]

    Active Not Recruiting PHASE1

  18. Jan 2017 — Feb 2017 [monthly]

    Active Not Recruiting PHASE1

    First recorded

Dec 2014

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 , Atlanta, United States , Barcelona, Spain , Cardiff, United Kingdom , Detroit, United States , L'Hospitalet de Llobregat, Spain , Maastricht, Netherlands , Madrid, Spain , Manchester, United Kingdom , Málaga, Spain and 4 more locations