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ceritinib

Generic: CERITINIB·Brand: ZYKADIA, Zykadia

ceritinib: developed by 1 company · 6 clinical trials tracked · 2 FDA decisions.

ceritinib evidence translation

What we can confirm

2 FDA records · 6 tracked trials

What it means

Source-backed records connect ceritinib to NVS; that link alone does not prove the drug works.

What to watch

Watch active trials and any change in FDA or trial status.
BioSniper AIPage evidence connected

Prepared research question

How could ceritinib → NVS affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence5 indications · 1 study sponsors

Related indications

ALK Positive Malignancies; ALK-positive NSCLC; Anaplastic Lymphoma Kinase (ALK)- Positive TumorsAdvanced MelanomaCancerMelanomaNeuroblastoma
Development Pipeline (2)
CompanyPhase
Novartis AG (NVS)
ALK Positive Malignancies; ALK-positive NSCLC; Anaplastic Ly…
Phase 4
Novartis AG (NVS)Approved
Clinical Trials (6)

Managed Access Programs for LDK378, Ceritinib

NCT05100134·NVS
No longer available
Expanded AccessNovartis Pharmaceuticals

Phase 1 Study of Trametinib + Ceritinib in Patients With Unresectable Melanoma

NCT03501368·Phase 1
Completed

Primary endpoint: Maximum Tolerated Dose (MTD) and recommended Phase 2 Dose (RP2D)

Interventionalopen27 enrolledStarted 2018-06Completion 2024-121 site · United StatesH. Lee Moffitt Cancer Center and Research Institute

Next Generation Personalized Neuroblastoma Therapy (The NEPENTHE Trial)

NCT02780128·Phase 1
Terminated

Primary endpoint: Incidence of dose limiting toxicities when combining ceritinib with ribociclib

Interventionalopen66 targetStarted 2016-07Completion 2022-081 site · United StatesYael P Mosse

An Open-label, Multi-center, Phase IV Roll-over Study in Patients With ALK Positive Malignancies Who Have Completed a Novartis-sponsored Ceritinib (LDK378) Study and Are Judged by the Investigator to Benefit From Continued Treatment With Ceritinib

NCT02584933·Phase 4·NVS
Active, not recruiting

Primary endpoint: Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Interventionalopen233 targetStarted 2015-12Completion 2027-0650 sites · Australia, Belgium, Brazil, Bulgaria…Novartis Pharmaceuticals

A Study Using Molecular Guided Therapy With Induction Chemotherapy Followed by a Randomized Controlled Trial of Standard Immunotherapy With or Without DFMO Followed by DFMO Maintenance for Subjects With Newly Diagnosed High-Risk Neuroblastoma

NCT02559778·Phase 2·FLNA
Recruiting

Primary endpoint: Number of days from start of therapy to date of first relapse

InterventionalRandomizedopen500 targetStarted 2015-09Completion 2035-0927 sites · Canada, United StatesGiselle Sholler

A Multi-center, Open-label Study to Assess the Safety and Efficacy of Combination Ceritinib (LDK378) and Nivolumab in Adult Patients With Anaplastic Lymphoma Kinase (ALK)-Positive Non-small Cell Lung Cancer (NSCLC)

NCT02393625·Phase 1·NVS
Active, not recruiting

Primary endpoint: Maximum Tolerated Dose (MTD) and/or Recommended Dose for Expansion

Interventionalopen57 targetStarted 2015-05Completion 2027-0412 sites · Australia, Belgium, Canada, Hong Kong…Novartis Pharmaceuticals
FDA Decisions2 records
Approval(NVS)FDA ↗
NDA211225UNKNOWNOrphan DrugStandardOralTablet
Approval(NVS)FDA ↗
NDA205755Type 1 - New Molecular EntityOrphan DrugPriorityOralCapsule

Frequently asked questions

Who is developing ceritinib?

ceritinib is being developed by Novartis AG.

How many clinical trials involve ceritinib?

BioSniper tracks 6 clinical trials involving ceritinib.

What is ceritinib's latest FDA decision?

The most recent tracked FDA decision for ceritinib is Approval, dated March 18, 2019.