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NCT02336451 · ClinicalTrials.gov registry record · Phase 2
A Phase II Study to Evaluate the Efficacy and Safety of Oral Ceritinib in Patients With ALK-positive NSCLC Metastatic to the Brain and/or to Leptomeninges
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 156
- Enrollment target
NCT02336451: Completed Phase 2 study, sponsored by Novartis Pharmaceuticals.
NCT02336451 is a Phase 2 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 156 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (17% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02336451, a Phase 2 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 156 participants
- Enrollment target
Study Summary
This was a phase II, multi-center, open-label, five-arm study in which the efficacy and safety of oral ceritinib treatment was assessed in patients with NSCLC metastatic to the brain and/or to leptomeninges harboring a confirmed ALK rearrangement, using the FDA approved Vysis ALK Break Apart FISH Probe Kit (Abbott Molecular Inc.) test and scoring algorithm (including positivity criteria). If documentation of ALK rearrangement as described above was not locally available, a test to confirm ALK rearrangement was performed by a Novartis designated central laboratory. Patients waited for the central laboratory result of the ALK rearrangement status before initiating treatment with ceritinib.
Primary Outcome
Overall response rate (ORR) is defined as the percentage of participants with a best overall confirmed response of complete response (CR) or partial response (PR) in the whole body as assessed per RECIST 1.1 by the investigator. CR: Disappearance of all non-nodal target and non-target lesions. In addition, all lymph nodes assigned a target or a non-target lesions must be non-pathological in size (\< 10 mm short axis), and no new lesion is identified. PR: When all target lesions have disappeared
Interventions
- DRUG Ceritinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 156 participants |
| Start Date | 2015-04-01 |
| Est. Completion | 2019-02-06 |
| Phase | Phase 2 |
What the finished NCT02336451 record still lists
NCT02336451 is an interventional study that assigns participants to a tested intervention. The registered 156 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (17% higher).
The record links to 0 conditions, and to 1 intervention - of which Ceritinib is the first listed.
NCT02336451 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02336451 about?
NCT02336451 is a clinical study titled "A Phase II Study to Evaluate the Efficacy and Safety of Oral Ceritinib in Patients With ALK-positive NSCLC Metastatic to the Brain and/or to Leptomeninges". This was a phase II, multi-center, open-label, five-arm study in which the efficacy and safety of oral ceritinib treatment was assessed in patients with NSCLC metastatic to the brain and/or to leptomeninges harboring a confirmed ALK rearrangement, using the FDA approved Vysis ALK Break Apart FISH Pr...
What is the current status of trial NCT02336451?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 156 participants. The study started on 2015-04-01. Estimated completion is 2019-02-06.
What interventions are being tested in trial NCT02336451?
The interventions under investigation include: Ceritinib (DRUG).
Who is sponsoring clinical trial NCT02336451?
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 NCT02336451's enrollment target sits among peer trials
156 445th of 2000 higher than 1,553 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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