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NCT02605746 · ClinicalTrials.gov registry record · Early Phase 1
Preoperative Ceritinib (LDK378) in Glioblastoma Multiforme and CNS Metastasis
A Early Phase 1 study, sponsored by St. Joseph's Hospital and Medical Center, Phoenix.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 10
- Enrollment target
NCT02605746: Completed Early Phase 1 study, sponsored by St. Joseph's Hospital and Medical Center, Phoenix.
NCT02605746 is a Early Phase 1 study that has completed, run by St. Joseph's Hospital and Medical Center, Phoenix. The registered enrollment target is 10 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02605746, a Early Phase 1 study, has completed, sponsored by St. Joseph's Hospital and Medical Center, Phoenix.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 10 participants
- Enrollment target
Study Summary
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.
Primary Outcome
Plasma concentration of Ceritinib after 10-14 oral doses of 750 mg. Will be summarized using descriptive statistics.
Interventions
- DRUG ceritinib 750mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2016-02-17 |
| Est. Completion | 2019-07-12 |
| Phase | Early Phase 1 |
What the finished NCT02605746 record still lists
NCT02605746 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 1 intervention - of which ceritinib 750mg is the first listed.
NCT02605746 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02605746 about?
NCT02605746 is a clinical study titled "Preoperative Ceritinib (LDK378) in Glioblastoma Multiforme and CNS Metastasis". 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 Pha...
What is the current status of trial NCT02605746?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 10 participants. The study started on 2016-02-17. Estimated completion is 2019-07-12.
What interventions are being tested in trial NCT02605746?
The interventions under investigation include: ceritinib 750mg (DRUG).
Who is sponsoring clinical trial NCT02605746?
This trial is sponsored by St. Joseph's Hospital and Medical Center, Phoenix, which has 44 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02605746's enrollment target sits among peer trials
10 1629th of 2000 higher than 256 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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