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NCT02299505 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetic and Safety Study of Lower Doses of Ceritinib Taken With a Low-fat Meal Versus 750 mg of Ceritinib in the Fasted State in Adult Patients With (ALK-positive) Metastatic Non-small Cell Lung Cancer (NSCLC)
A Phase 1 study of Non-Small Cell Lung Cancer, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 306
- Enrollment target
- 20
- Study locations
NCT02299505: Completed Phase 1 study of Non-Small Cell Lung Cancer, sponsored by Novartis Pharmaceuticals.
NCT02299505 is a Phase 1 study of Non-Small Cell Lung Cancer that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 306 participants, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (53% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02299505, a Phase 1 study of Non-Small Cell Lung Cancer, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 306 participants
- Enrollment target
- 20
- Study locations
Study Summary
A Phase I study to assess the systemic exposure, effiacy, and safety of 450 mg ceritinib taken with a low-fat meal and 600 mg ceritinib taken with a low-fat meal as compared with that of 750 mg ceritinib taken in the fasted state in adult patients with ALK rearranged (ALK-positive) metastatic non-small cell lung cancer (NSCLC)
Primary Outcome
Pharmacokinetics (PK) parameters, including but not limited to AUClast, AUC0-24h, Cmax, Tmax, Tlast, Racc, and CLss/F
Conditions Studied
Interventions
- DRUG ceritinib
Study Locations (20)
Other
- Novartis Investigative Site - Auckland
- Novartis Investigative Site - Vienna
- Novartis Investigative Site - Vienna
- Novartis Investigative Site - Edegem
- Novartis Investigative Site - Sofia
Rio Grande do Sul
- Novartis Investigative Site - Passo Fundo
- Novartis Investigative Site - Porto Alegre
São Paulo
- Novartis Investigative Site - Barretos
- Novartis Investigative Site - São Paulo
Arkansas
- Highlands Oncology Group - Fayetteville
California
- Loma Linda University - Loma Linda
Indiana
- Goshen Center for Cancer Care IU Health - SC - Indianapolis
Maryland
- Maryland Oncology Hematology, P.A. SC-2 - Rockville
New Jersey
- Essex Oncology of North Jersey PA SC - Belleville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 306 participants |
| Start Date | 2015-04-09 |
| Est. Completion | 2020-03-06 |
| Phase | Phase 1 |
What the finished NCT02299505 record still lists
NCT02299505 is an interventional study that assigns participants to a tested intervention. The registered 306 participants enrollment target is mid-sized for trials with a published cap, below the 652-participant average among 454 other Non-Small Cell Lung Cancer trials with a reported enrollment target (53% lower).
The record links to 1 condition, with Non-Small Cell Lung Cancer appearing as the primary indexed condition, and to 1 intervention - of which ceritinib is the first listed.
NCT02299505 names 20 study sites across 14 states, led by Other, Rio Grande do Sul, São Paulo.
Frequently Asked Questions
What is clinical trial NCT02299505 about?
NCT02299505 is a clinical study titled "Pharmacokinetic and Safety Study of Lower Doses of Ceritinib Taken With a Low-fat Meal Versus 750 mg of Ceritinib in the Fasted State in Adult Patients With (ALK-positive) Metastatic Non-small Cell Lung Cancer (NSCLC)". A Phase I study to assess the systemic exposure, effiacy, and safety of 450 mg ceritinib taken with a low-fat meal and 600 mg ceritinib taken with a low-fat meal as compared with that of 750 mg ceritinib taken in the fasted state in adult patients with ALK rearranged (ALK-positive) metastatic non-sm...
What is the current status of trial NCT02299505?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 306 participants. The study started on 2015-04-09. Estimated completion is 2020-03-06.
What conditions does trial NCT02299505 study?
This clinical trial studies the following conditions: Non-Small Cell Lung Cancer.
What interventions are being tested in trial NCT02299505?
The interventions under investigation include: ceritinib (DRUG).
Who is sponsoring clinical trial NCT02299505?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02299505 being conducted?
This trial has 20 study locations across Arkansas, California, Indiana, Maryland, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02299505's enrollment target sits among peer trials
306 123rd of 454 higher than 332 of 454 other Non-Small Cell Lung Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-Small Cell Lung Cancer 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.
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