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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 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 658-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (53% lower). The trial reports 20 study locations across 14 states.

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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)

Conditions Studied

Non-Small Cell Lung Cancer

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

FieldValue
Enrollment Target 306 participants
Start Date 2015-04-09
Est. Completion 2020-03-06
Phase Phase 1

Sponsor

Novartis Pharmaceuticals

1,375 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02299505

The ClinicalTrials.gov registry entry for NCT02299505 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 306 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 658-participant average among 449 other Non-Small Cell Lung Cancer trials with a reported enrollment target (53% lower). The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 14 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.