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NCT02605746
Preoperative Ceritinib (LDK378) in Glioblastoma Multiforme and CNS Metastasis
EARLY_PHASE1 trial testing ceritinib 750mg in Glioblastoma in 10 participants. Completed in 12 July 2019.
29 November 2018
Quick facts
| Lead sponsor | St. Joseph's Hospital and Medical Center, Phoenix |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | other |
| Enrollment | 10 |
| Start date | 17 February 2016 |
| Primary completion | 29 November 2018 |
| Estimated completion | 12 July 2019 |
| Sites | 1 location across United States |
Drugs / interventions tested
- ceritinib 750mg — full drug profile →
Conditions studied
- Glioblastoma — all drugs for Glioblastoma →
- Brain Metastases — all drugs for Brain Metastases →
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):
-
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 -
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 -
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 -
Glioma Stem Cells-Features for New Therapy Design.
Pećina-Šlaus N, Hrašćan R. · · 2024 · cited 7× · PMID 38672638 · DOI 10.3390/cancers16081557 -
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
Verify or expand the search:
- PubMed search for NCT02605746
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02605746 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by St. Joseph's Hospital and Medical Center, Phoenix
- Last refreshed: 11 December 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02605746.
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