Ceritinib dihydrochloride Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 370

Clinical Trials

Numerous clinical trials spanning Early Phase 1 through Phase 4 evaluate ceritinib as a monotherapy and combination therapy for diverse oncological indications, including ALK-positive advanced solid tumors, ROS1-rearranged non-small cell lung cancer, gastrointestinal adenocarcinomas, neuroblastoma, and anaplastic large cell lymphoma. Sponsored by academic medical centers and pharmaceutical leaders including Novartis and Pfizer, these studies encompass active recruitment, completed evaluations, non-recruiting protocols, and terminated or withdrawn investigations.

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NCT02729961	WITHDRAWN	Anaplastic Large Cell Lymphoma, ALK-Positive; CD30-Positive Neoplastic Cells Present; Systemic Anaplastic Large Cell Lymphoma	University of Washington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
NCT03087448	Terminated	Non-small Cell Lung Cancer	University of California San Francisco\|Novartis Pharmaceuticals\|University of California Davis	2017-09-09	Phase 1
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
NCT02638909	Terminated	Colorectal Adenocarcinoma\|Cholangiocarcinoma\|Pancreatic Adenocarcinoma\|Hepatocellular Adenocarcinoma\|Gastric Adenocarcinoma\|Esophageal Adenocarcinoma	Criterium Inc.\|University of Colorado Denver\|Novartis	2015-12	Phase 2
NCT02422589	Completed	ALK-positive Advanced Tumors	Novartis Pharmaceuticals\|Novartis	2015-10-23	Phase 1

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

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ceritinib dihydrochloride functions as a selective, ATP-competitive inhibitor of anaplastic lymphoma kinase (ALK) that blocks autophosphorylation and downstream signal transduction, thereby inhibiting proliferation and inducing apoptosis in kinase-dependent cancer cells. By suppressing oncogenic ALK and related signaling pathways, this compound exhibits potent antitumor activity relevant to clinical evaluation in ALK-positive non-small cell lung cancer, gastrointestinal malignancies, and neuroblastoma.

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>).