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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: Completed Phase 1 study, sponsored by Novartis Pharmaceuticals.
NCT01742286 is a Phase 1 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 83 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (38% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
A DLT is defined as an adverse event or abnormal laboratory value assessed as unrelated to disease, disease progression, inter-current illness, or concomitant therapies that occurs within the first 21 days of treatment with LDK378 and meets a specified defined criteria. A participant with multiple occurrences of DLTs under one treatment is counted only once in the Adverse Event category for that treatment. A participant with multiple DLTs within a primary system organ class is counted only once
Interventions
- DRUG Ceritinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 83 participants |
| Start Date | 2013-08-28 |
| Est. Completion | 2019-04-26 |
| Phase | Phase 1 |
What the finished NCT01742286 record still lists
NCT01742286 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 83 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (38% higher).
The record links to 0 conditions, and to 1 intervention - of which Ceritinib is the first listed.
NCT01742286 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01742286's enrollment target sits among peer trials
83 665th of 2000 higher than 1,332 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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