Clinical Trials

Numerous clinical trials across Early Phase 1 through Phase 4 evaluate the therapeutic efficacy, safety, and pharmacokinetics of ceritinib (LDK378), primarily focusing on ALK- and ROS1-rearranged non-small-cell lung cancer, advanced solid neoplasms, neuroblastoma, anaplastic large cell lymphoma, and hepatic impairment cohorts. Featuring both monotherapy protocols and combination regimens, these investigations are supported by pharmaceutical sponsors like Novartis and Pfizer alongside academic institutions such as M.D. Anderson Cancer Center and Yonsei University. Trial recruitment statuses across the portfolio range from completed and active to recruiting, withdrawn, or terminated.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT02559778 RECRUITING
Neuroblastoma
Giselle Sholler
 2015-09 PHASE2
NCT06813079 RECRUITING
Pancreatic Ductal Carcinoma; Advanced Cancer; Epithelial Tumor
University Health Network, Toronto
 2025-04-07 PHASE2
NCT02584933 ACTIVE_NOT_RECRUITING
ALK Positive Malignancies
Novartis Pharmaceuticals
 2015-12-11 PHASE4
NCT02393625 ACTIVE_NOT_RECRUITING
ALK-positive NSCLC
Novartis Pharmaceuticals
 2015-05-27 PHASE1
NCT02321501 ACTIVE_NOT_RECRUITING
ALK Positive; Locally Advanced Malignant Solid Neoplasm; Metastatic Malignant Solid Neoplasm; ROS1 Gene Rearrangement; Stage IIIB Lung Non-Small Cell Cancer AJCC v7; Stage IV Lung Non-Small Cell Cancer AJCC v7
M.D. Anderson Cancer Center
 2016-06-22 PHASE1
NCT03611738 ACTIVE_NOT_RECRUITING
Non-small Cell Lung Cancer; Lung Cancer; Non-small Cell Lung Cancer Metastatic; Non-small Cell Lung Cancer Stage IIIB; Stage IV Non-small Cell Lung Cancer; EGFR Negative Non-Small Cell Lung Cancer
H. Lee Moffitt Cancer Center and Research Institute
 2019-02-01 PHASE1
NCT03784014 COMPLETED
Soft Tissue Sarcoma
Institut National de la Santé Et de la Recherche Médicale, France
 2019-10-19 PHASE3
NCT02729961 WITHDRAWN
Anaplastic Large Cell Lymphoma, ALK-Positive; CD30-Positive Neoplastic Cells Present; Systemic Anaplastic Large Cell Lymphoma
University of Washington
 2018-01-03 PHASE1; PHASE2
NCT03501368 COMPLETED
Melanoma; Unresectable Melanoma; Advanced Melanoma
H. Lee Moffitt Cancer Center and Research Institute
 2018-06-27 PHASE1
NCT02780128 TERMINATED
Neuroblastoma; Cancer
Yael P Mosse
 2016-07 PHASE1
NCT03087448 TERMINATED
Non-small Cell Lung Cancer
University of California, San Francisco
 2017-09-09 PHASE1
NCT03737994 TERMINATED
Lung Non-Squamous Non-Small Cell Carcinoma; Stage IV Lung Cancer AJCC v8; Stage IVA Lung Cancer AJCC v8; Stage IVB Lung Cancer AJCC v8
National Cancer Institute (NCI)
 2019-07-25 PHASE2
NCT02343679 WITHDRAWN
Hematologic Malignancies
Anne Beaven, MD
 2015-05 PHASE2
NCT03535740 COMPLETED
ALK-positive Advanced NSCLC
Ariad Pharmaceuticals
 2019-01-31 PHASE2
NCT02513667 TERMINATED
ALK-positive Non-small Cell Lung Cancer
University of Texas Southwestern Medical Center
 2015-11 PHASE2
NCT03399487 UNKNOWN
Non-small Cell Lung Cancer Harboring ROS1 Rearrangement
Yonsei University
 2018-07-24 PHASE2
NCT01742286 COMPLETED
ALK-activated Tumors
Novartis Pharmaceuticals
 2013-08-28 PHASE1
NCT02336451 COMPLETED
ALK-positive Non-small Cell Lung Cancer
Novartis Pharmaceuticals
 2015-04-01 PHASE2
NCT02289144 WITHDRAWN
Metastatic Anaplastic Thyroid Cancer; Locally Advanced Anaplastic, Undifferentiated Thyroid Cancer
University of Texas Southwestern Medical Center
 2015-06 PHASE2
NCT02227940 COMPLETED
Advanced Malignant Solid Neoplasm; ALK Positive; Metastatic Pancreatic Adenocarcinoma; Stage III Pancreatic Cancer; Stage IV Pancreatic Cancer
Roswell Park Cancer Institute
 2015-01-08 PHASE1
NCT02605746 COMPLETED
Glioblastoma; Brain Metastases
St. Joseph's Hospital and Medical Center, Phoenix
 2016-02-17 EARLY_PHASE1
NCT02292550 COMPLETED
Non-small Cell Lung Cancer
Novartis Pharmaceuticals
 2015-05-14 PHASE1
NCT02465528 TERMINATED
Tumors With Aberrations in ALK; Anaplastic Large Cell Lymphoma; Inflammatory Myofibroblastic Tumor; Glioblastoma
Novartis Pharmaceuticals
 2016-05-06 PHASE2
NCT02587650 TERMINATED
ALK Fusion Protein Expression; BRAF wt Allele; Invasive Skin Melanoma; MET Fusion Gene Positive; NRAS wt Allele; NTRK1 Fusion Positive; NTRK2 Fusion Positive; NTRK3 Fusion Positive; RET Fusion Positive; ROS1 Fusion Positive; Stage III Cutaneous Melanoma; Stage IIIA Cutaneous Melanoma; Stage IIIB Cutaneous Melanoma; Stage IIIC Cutaneous Melanoma; Stage IV Cutaneous Melanoma
University of California, San Francisco
 2015-03-26 PHASE2
NCT02638909 TERMINATED
Colorectal Adenocarcinoma; Cholangiocarcinoma; Pancreatic Adenocarcinoma; Hepatocellular Adenocarcinoma; Gastric Adenocarcinoma; Esophageal Adenocarcinoma
Criterium, Inc.
 2015-12 PHASE2
NCT02186821 TERMINATED
Tumors With Aberrations in ALK or ROS1
Novartis Pharmaceuticals
 2014-09-17 PHASE2
NCT02422589 COMPLETED
ALK-positive Advanced Tumors
Novartis Pharmaceuticals
 2015-10-23 PHASE1
NCT01828099 COMPLETED
Non-Small Cell Lung Cancer
Novartis Pharmaceuticals
 2013-07-09 PHASE3
NCT02299505 COMPLETED
Non-Small Cell Lung Cancer
Novartis Pharmaceuticals
 2015-04-09 PHASE1
NCT01828112 COMPLETED
Non-Small Cell Lung Cancer
Novartis Pharmaceuticals
 2013-06-28 PHASE3
NCT02450903 Completed
Non-Small-Cell Lung Cancer
Novartis Pharmaceuticals|Novartis
 2015-08-21 Phase 2
NCT02040870 Completed
Non-Small Cell Lung Cancer
Novartis Pharmaceuticals|Novartis
 2014-03-07 Phase 1|Phase 2
NCT01950481 Completed
Normal Hepatic Function|Impaired Hepatic Function
Novartis Pharmaceuticals|Novartis
 2014-01 Phase 1
NCT01772797 Completed
Anaplastic Lymphoma Kinase (ALK)|Non-small Cell Lung Cancer
Novartis Pharmaceuticals|Novartis
 2013-06 Phase 1
NCT01685060 Completed
Non-Small Cell Lung Cancer
Novartis Pharmaceuticals|Novartis
 2012-11-26 Phase 2
NCT01634763 Completed
Tumors Characterized by Genetic Alterations in Anaplastic Lymphoma Kinase (ALK)
Novartis Pharmaceuticals|Novartis
 2012-06 Phase 1

(data from https://clinicaltrials.gov, updated on 2026-09-04)

Check the Ceritinib (LDK378) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ceritinib selectively binds to the ATP-binding pocket of anaplastic lymphoma kinase (ALK) and related receptor tyrosine kinases including IGF-1R, InsR, STK22D, and FLT3, thereby blocking autophosphorylation and suppressing downstream RAS/RAF/MEK/ERK and PI3K/AKT/mTOR signaling pathways. Interruption of these oncogenic cascades induces cell cycle arrest and apoptosis in tumor cells, providing a clear biological rationale for its clinical evaluation in ALK- and ROS1-rearranged malignancies such as non-small-cell lung cancer.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.