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NCT02605746

Preoperative Ceritinib (LDK378) in Glioblastoma Multiforme and CNS Metastasis

Completed EARLY_PHASE1 Last updated 11 December 2020
What this trial tests

EARLY_PHASE1 trial testing ceritinib 750mg in Glioblastoma in 10 participants. Completed in 12 July 2019.

Timeline
17 February 2016
Primary endpoint
29 November 2018
12 July 2019

Quick facts

Lead sponsorSt. Joseph's Hospital and Medical Center, Phoenix
PhaseEARLY_PHASE1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposeother
Enrollment10
Start date17 February 2016
Primary completion29 November 2018
Estimated completion12 July 2019
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

St. Joseph's Hospital and Medical Center, Phoenix

Who can join

18 and older, any sex, with Glioblastoma or Brain Metastases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is two parallel studies to examine pharmacokinetic (PK), pharmacodynamic (PD), and pharmacogenetic (PG) endpoints following short-interval therapy (10-14) daily doses without dose reduction and interruption) with the ALK (anaplastic lymphoma kinase) small-molecule inhibitor, ceritinib. The Phase 0 study will investigate: 1. first recurrence GBM patients and 2. patients with CNS metastases from solid tumors such as, but not limited to, NSCLC (non-small cell lung cancer) and melanoma. The CNS (central nervous system) metastases Phase 0 is designed to identify PK effects (in addition to PD, and PG effects on ALK-positive NSCLC metastases), while the GBM Phase 0 is designed to identify PK, PD, and PG effects in all patients.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

  1. A Phase 0 Trial of Ceritinib in Patients with Brain Metastases and Recurrent Glioblastoma.
    Mehta S, Fiorelli R, Bao X, Pennington-Krygier C, et al · · 2022 · cited 18× · PMID 34702773 · DOI 10.1158/1078-0432.ccr-21-1096
  2. Small Molecule Tyrosine Kinase Inhibitors (TKIs) for Glioblastoma Treatment.
    Frumento D, Grossi G, Falesiedi M, Musumeci F, et al · · 2024 · cited 16× · PMID 38338677 · DOI 10.3390/ijms25031398
  3. A liquid chromatography with tandem mass spectrometry method for quantitating total and unbound ceritinib in patient plasma and brain tumor.
    Bao X, Wu J, Sanai N, Li J. · · 2018 · cited 13× · PMID 29568664 · DOI 10.1016/j.jpha.2017.07.007
  4. Glioma Stem Cells-Features for New Therapy Design.
    Pećina-Šlaus N, Hrašćan R. · · 2024 · cited 7× · PMID 38672638 · DOI 10.3390/cancers16081557
  5. Therapeutic Monitoring of Orally Administered, Small-Molecule Anticancer Medications with Tumor-Specific Cellular Protein Targets in Peripheral Fluid Spaces-A Review.
    Köllő Z, Garami M, Vincze I, Vásárhelyi B, et al · · 2023 · cited 1× · PMID 36678867 · DOI 10.3390/pharmaceutics15010239

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Other recruiting trials for Glioblastoma

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