deltatrials
Completed PHASE1 INTERVENTIONAL 1-arm NCT01742286

Phase I Study of LDK378 in Pediatric, Malignancies With a Genetic Alteration in Anaplastic Lymphoma Kinase (ALK)

A Phase I, Open-label, Dose Escalation Study of LDK378 in Pediatric Patients With Malignancies That Have a Genetic Alteration in Anaplastic Lymphoma Kinase (ALK)

Sponsor: Novartis Pharmaceuticals

Conditions ALK-activated Tumors
Interventions Ceritinib
Updated 19 times since 2017 Last updated: May 27, 2020 Started: Aug 28, 2013 Primary completion: Apr 26, 2019 Completion: Apr 26, 2019
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 ALK-activated Tumors and is currently completed. Novartis Pharmaceuticals leads this study, which shows 19 recorded versions since 2013 — 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 – ~Jul 2017 · 2 months · monthly snapshot~Jul 2017 – ~Jun 2018 · 11 months · monthly snapshot~Jun 2018 – ~Aug 2018 · 2 months · monthly snapshot~Aug 2018 – ~Nov 2018 · 3 months · monthly snapshot~Nov 2018 – ~Dec 2018 · 30 days · monthly snapshot~Dec 2018 – ~Feb 2019 · 2 months · monthly snapshot~Feb 2019 – ~Apr 2019 · 59 days · monthly snapshot~Apr 2019 – ~May 2019 · 30 days · monthly snapshot~May 2019 – ~Jun 2019 · 31 days · monthly snapshot~Jun 2019 – ~Jul 2019 · 30 days · monthly snapshot~Jul 2019 – ~Sep 2019 · 2 months · monthly snapshot~Sep 2019 – ~Jul 2020 · 10 months · monthly snapshot~Jul 2020 – ~Jan 2021 · 6 months · monthly snapshot~Jan 2021 – ~Jul 2024 · 42 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

19 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. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE1

  5. Jul 2020 — Jan 2021 [monthly]

    Completed PHASE1

▶ Show 14 earlier versions

  1. Sep 2019 — Jul 2020 [monthly]

    Completed PHASE1

  2. Jul 2019 — Sep 2019 [monthly]

    Completed PHASE1

  3. Jun 2019 — Jul 2019 [monthly]

    Completed PHASE1

    Status: Active Not Recruiting → Completed

  4. May 2019 — Jun 2019 [monthly]

    Active Not Recruiting PHASE1

    Status: Recruiting → Active Not Recruiting

  5. Apr 2019 — May 2019 [monthly]

    Recruiting PHASE1

  6. Feb 2019 — Apr 2019 [monthly]

    Recruiting PHASE1

  7. Dec 2018 — Feb 2019 [monthly]

    Recruiting PHASE1

  8. Nov 2018 — Dec 2018 [monthly]

    Recruiting PHASE1

    Status: Active Not Recruiting → Recruiting

  9. Aug 2018 — Nov 2018 [monthly]

    Active Not Recruiting PHASE1

    Status: Recruiting → Active Not Recruiting

  10. Jun 2018 — Aug 2018 [monthly]

    Recruiting PHASE1

  11. Jul 2017 — Jun 2018 [monthly]

    Recruiting PHASE1

  12. May 2017 — Jul 2017 [monthly]

    Recruiting PHASE1

  13. Feb 2017 — May 2017 [monthly]

    Recruiting PHASE1

  14. Jan 2017 — Feb 2017 [monthly]

    Recruiting PHASE1

    First recorded

Aug 2013

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Novartis Pharmaceuticals
Data source: Novartis

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

Study Locations

Amsterdam, Netherlands , Barcelona, Spain , Berlin, Germany , Boston, United States , Cincinnati, United States , Cologne, Germany , Essen, Germany , Houston, United States , Madrid, Spain , Memphis, United States and 13 more locations