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NCT01742286 · ClinicalTrials.gov registry record · Phase 1
Phase I Study of LDK378 in Pediatric, Malignancies With a Genetic Alteration in Anaplastic Lymphoma Kinase (ALK)
A Phase 1 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 83
- Enrollment target
NCT01742286 is a Phase 1 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 83 participants.
The verdict
NCT01742286, a Phase 1 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 83 participants
- Enrollment target
Study Summary
The purpose of this study was to estimate the maximum tolerated dose and/or recommended dose for expansion of LDK378 as a single agent, assess safety, tolerability and anti-tumor activity and characterize single and multiple-dose pharmacokinetics when administered orally to pediatric patients with ALK-activated tumors, with and without food.
Interventions
- DRUG Ceritinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 83 participants |
| Start Date | 2013-08-28 |
| Est. Completion | 2019-04-26 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01742286
The ClinicalTrials.gov registry entry for NCT01742286 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 83 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Ceritinib is the first listed.
NCT01742286 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01742286 about?
NCT01742286 is a clinical study titled "Phase I Study of LDK378 in Pediatric, Malignancies With a Genetic Alteration in Anaplastic Lymphoma Kinase (ALK)". The purpose of this study was to estimate the maximum tolerated dose and/or recommended dose for expansion of LDK378 as a single agent, assess safety, tolerability and anti-tumor activity and characterize single and multiple-dose pharmacokinetics when administered orally to pediatric patients with A...
What is the current status of trial NCT01742286?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 83 participants. The study started on 2013-08-28. Estimated completion is 2019-04-26.
What interventions are being tested in trial NCT01742286?
The interventions under investigation include: Ceritinib (DRUG).
Who is sponsoring clinical trial NCT01742286?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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