Clinical Trials

Numerous clinical trials evaluate crizotinib hydrochloride across various oncological indications, focusing primarily on ALK- or ROS1-rearranged non-small cell lung cancer alongside anaplastic large cell lymphoma, papillary renal cell carcinoma, and advanced solid neoplasms. Spanning Phase 1 safety evaluations through Phase 4 post-marketing surveillance, these studies report recruitment statuses ranging from active and ongoing enrollment to completed and terminated phases. The trials are sponsored by a mix of pharmaceutical companies, including Pfizer and Roche, alongside major academic institutions such as M.D. Anderson Cancer Center.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05725200 RECRUITING
Metastatic Colorectal Cancer
Oslo University Hospital
 2022-09-27 PHASE2
NCT02201992 ACTIVE_NOT_RECRUITING
ALK Gene Rearrangement; ALK Gene Translocation; ALK Positive; Stage IB Non-Small Cell Lung Carcinoma AJCC v7; Stage II Non-Small Cell Lung Cancer AJCC v7; Stage IIA Non-Small Cell Lung Carcinoma AJCC v7; Stage IIB Non-Small Cell Lung Carcinoma AJCC v7; Stage IIIA Non-Small Cell Lung Cancer AJCC v7
ECOG-ACRIN Cancer Research Group
 2015-03-23 PHASE3
NCT07804186 RECRUITING
Uveal Melanoma
IDEAYA Biosciences
 2026-09 PHASE3
NCT07560410 NOT_YET_RECRUITING
Bone Cancer
China Medical University Hospital
 2026-05-15 PHASE1; PHASE2
NCT06564324 RECRUITING
Non Small Cell Lung Cancer
Nuvation Bio Inc.
 2024-11-27 PHASE3
NCT05160922 ACTIVE_NOT_RECRUITING
NSCLC; ALCL; IMT
Pfizer
 2021-12-27 PHASE4
NCT04693468 RECRUITING
Advanced Malignant Solid Neoplasm; Metastatic Malignant Solid Neoplasm; Recurrent Malignant Solid Neoplasm
M.D. Anderson Cancer Center
 2020-12-01 PHASE1
NCT06563999 RECRUITING
Lung Cancer Stage III; Mutation
Sun Yat-sen University
 2024-11-01 PHASE2
NCT02925234 RECRUITING
Cancer; Tumors; Neoplasm; Neoplasia
The Netherlands Cancer Institute
 2016-08 PHASE2
NCT03947385 RECRUITING
Metastatic Uveal Melanoma; Cutaneous Melanoma; Colorectal Cancer; Other Solid Tumors
IDEAYA Biosciences
 2019-06-28 PHASE1; PHASE2
NCT05987332 ACTIVE_NOT_RECRUITING
Metastatic Uveal Melanoma
IDEAYA Biosciences
 2023-10-31 PHASE2; PHASE3
NCT02465060 ACTIVE_NOT_RECRUITING
Advanced Lymphoma; Advanced Malignant Solid Neoplasm; Bladder Carcinoma; Breast Carcinoma; Cervical Carcinoma; Colon Carcinoma; Colorectal Carcinoma; Endometrial Carcinoma; Esophageal Carcinoma; Exocrine Pancreas Carcinoma; Gastric Carcinoma; Glioma; Head and Neck Carcinoma; Hematopoietic and Lymphoid Cell Neoplasm; Kidney Carcinoma; Liver Carcinoma; Lung Carcinoma; Lymphoma; Malignant Uterine Corpus Neoplasm; Malignant Uterine Neoplasm; Melanoma; Multiple Myeloma; Ovarian Carcinoma; Prostate Carcinoma; Rectal Carcinoma; Recurrent Bladder Carcinoma; Recurrent Breast Carcinoma; Recurrent Cervical Carcinoma; Recurrent Colon Carcinoma; Recurrent Colorectal Carcinoma; Recurrent Esophageal Carcinoma; Recurrent Gastric Carcinoma; Recurrent Glioma; Recurrent Head and Neck Carcinoma; Recurrent Liver Carcinoma; Recurrent Lung Carcinoma; Recurrent Lymphoma; Recurrent Malignant Solid Neoplasm; Recurrent Malignant Uterine Corpus Neoplasm; Recurrent Melanoma; Recurrent Multiple Myeloma; Recurrent Ovarian Carcinoma; Recurrent Pancreatic Carcinoma; Recurrent Prostate Carcinoma; Recurrent Rectal Carcinoma; Recurrent Skin Carcinoma; Recurrent Thyroid Gland Carcinoma; Refractory Lymphoma; Refractory Malignant Solid Neoplasm; Refractory Multiple Myeloma; Skin Carcinoma; Thyroid Gland Carcinoma
National Cancer Institute (NCI)
 2015-08-17 PHASE2
NCT03297606 RECRUITING
Lymphoma, Non-Hodgkin; Multiple Myeloma; Advanced Solid Tumors
Canadian Cancer Trials Group
 2018-03-23 PHASE2
NCT04322890 RECRUITING
Non Small Cell Lung Cancer; EGFR Gene Mutation; ALK Gene Mutation; ROS1 Gene Mutation; MET Gene Mutation
Hunan Province Tumor Hospital
 2020-04-16 PHASE2
NCT04603807 ACTIVE_NOT_RECRUITING
Carcinoma, Non-Small-Cell Lung
Hoffmann-La Roche
 2021-09-30 PHASE3
NCT02194738 ACTIVE_NOT_RECRUITING
Stage IB Lung Non-Small Cell Carcinoma AJCC v7; Stage II Lung Non-Small Cell Cancer AJCC v7; Stage IIA Lung Cancer AJCC v8; Stage IIB Lung Cancer AJCC v8; Stage IIIA Lung Cancer AJCC v8; Stage IIIA Lung Non-Small Cell Cancer AJCC v7; Stage IIIB Lung Cancer AJCC v8
National Cancer Institute (NCI)
 2014-09-26
NCT04423185 RECRUITING
Rare Tumor
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
 2020-08-15 PHASE2
NCT05014464 RECRUITING
Non-small Cell Lung Cancer
Hunan Province Tumor Hospital
 2021-11-13 PHASE2
NCT06254599 NOT_YET_RECRUITING
Non-small Cell Lung Cancer
Shouyao Holdings (Beijing) Co. LTD
 2024-05-01 PHASE3
NCT06082635 ACTIVE_NOT_RECRUITING
Non Small Cell Lung Cancer
Shenzhen TargetRx Co., Ltd.
 2023-12-14 PHASE3
NCT06140836 ACTIVE_NOT_RECRUITING
Carcinoma, Non-Small-Cell Lung
Bristol-Myers Squibb
 2023-12-21 PHASE3
NCT02767804 ACTIVE_NOT_RECRUITING
Non-small Cell Lung Cancer
Xcovery Holdings, Inc.
 2016-06 PHASE3
NCT03194893 COMPLETED
Neoplasms
Hoffmann-La Roche
 2017-07-05 PHASE3
NCT06569420 ACTIVE_NOT_RECRUITING
Non-Small Cell Lung Cancer; ALK-positive; SAF-189s
Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.
 2021-12-31 PHASE3
NCT04030429 TERMINATED
Endometrial Cancer Recurrent
National Cheng-Kung University Hospital
 2019-09-01 PHASE2
NCT05204628 UNKNOWN
Non-small Cell Lung Cancer
Xuanzhu Biopharmaceutical Co., Ltd.
 2022-02-07 PHASE3
NCT04322578 UNKNOWN
Non-small Cell Lung Cancer
Hunan Province Tumor Hospital
 2020-03-24 PHASE2
NCT04283669 COMPLETED
Neurofibromatosis 2; Progressive Vestibular Schwannoma (VS)
University of Alabama at Birmingham
 2020-02-18 PHASE2
NCT04084717 COMPLETED
Non-squamous Non-small-cell Lung Cancer; Stage IV Non-small Cell Lung Cancer; ROS1 Gene Rearrangement; MET Activating Mutation; MET Amplification
University Health Network, Toronto
 2019-12-03 PHASE2
NCT04632758 UNKNOWN
Non-small Cell Lung Cancer
Qilu Pharmaceutical Co., Ltd.
 2019-06-01 PHASE3
NCT03620643 COMPLETED
Lobular Breast Carcinoma; Gastric Cancer; Triple Negative Breast Cancer; CDH1 Gene Mutation
Royal Marsden NHS Foundation Trust
 2019-05-09 PHASE2
NCT06062810 Not yet recruiting
Non-Small Cell Lung Cancer
Han Xu M.D. Ph.D. FAPCR Sponsor-Investigator IRB Chair|Medicine Invention Design Inc
 2024-03-28 Phase 2|Phase 3
NCT03596866 COMPLETED
ALK+ Advanced NSCLC
Takeda
 2019-04-19 PHASE3
NCT05297890 ACTIVE_NOT_RECRUITING
Advanced or Metastatic ROS1-Positive Non-Small Cell Lung Cancer
CStone Pharmaceuticals
 2022-05-27 PHASE2
NCT02664935 COMPLETED
Non-Small Cell Lung Cancer; Carcinoma, Squamous Cell; Adenocarcinoma
University of Birmingham
 2015-05-13 PHASE2
NCT02761057 COMPLETED
Locally Advanced Papillary Renal Cell Carcinoma; Metastatic Papillary Renal Cell Carcinoma; Stage III Renal Cell Cancer AJCC v7; Stage IV Renal Cell Cancer AJCC v7; Type 1 Papillary Renal Cell Carcinoma; Type 2 Papillary Renal Cell Carcinoma; Unresectable Renal Cell Carcinoma
National Cancer Institute (NCI)
 2016-07-25 PHASE2
NCT03672643 TERMINATED
ALK or ROS1-positive NSCLC
Pfizer
 2019-01-28 PHASE4
NCT01121588 TERMINATED
Neoplasms Malignant
Pfizer
 2011-03-22 PHASE1
NCT00828919 COMPLETED
Solid Tumors
Pfizer
 2003-03-07
NCT03574402 UNKNOWN
Carcinoma, Non-Small-Cell Lung
Guangdong Association of Clinical Trials
 2018-07-09 PHASE2
NCT04292119 UNKNOWN
Lung Cancer; Anaplastic Lymphoma Kinase Gene Translocation; ROS1 Rearrangement; Relapsed Cancer; MET Amplification; Resistant Cancer; NSCLC
Massachusetts General Hospital
 2020-05-01 PHASE1; PHASE2
NCT02419287 COMPLETED
Anaplastic Large Cell Lymphoma, ALK-Positive
University of Milano Bicocca
 2015-04 PHASE2
NCT06360575 ACTIVE_NOT_RECRUITING
Advanced Lymphoma; Advanced Malignant Solid Neoplasm; Refractory Lymphoma; Refractory Malignant Solid Neoplasm; Refractory Multiple Myeloma
National Cancer Institute (NCI)
 2016-07-20 PHASE2
NCT06357975 ACTIVE_NOT_RECRUITING
Advanced Lymphoma; Advanced Malignant Solid Neoplasm; Refractory Lymphoma; Refractory Malignant Solid Neoplasm; Refractory Multiple Myeloma
National Cancer Institute (NCI)
 2016-07-29 PHASE2
NCT03607188 COMPLETED
Non-small Cell Lung Cancer
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
 2018-10-18 PHASE1
NCT04211922 TERMINATED
ALK-positive Non-small Cell Lung Cancer
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
 2020-01-21 PHASE2
NCT03439215 UNKNOWN
Carcinoma, Non-Small-Cell Lung
Fondazione Ricerca Traslazionale
 2017-06-13 PHASE2
NCT05792644 COMPLETED
ALK Phosphorylation
Harbin Medical University
 2018-01-01
NCT04856293 COMPLETED
Healthy Participants
Pfizer
 2021-04-16 PHASE1
NCT02638428 UNKNOWN
Relapsed Pediatric Solid Tumor; Refractory Pediatric Solid Tumor; Relapsed Pediatric AML; Refractory Pediatric AML
Samsung Medical Center
 2015-12 PHASE2
NCT04009317 UNKNOWN
ALK-positive NSCLC
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
 2019-08-13 PHASE3
NCT04056572 UNKNOWN
ALK-positive NSCLC
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
 2019-08-13 PHASE2
NCT01548144 TERMINATED
Advanced Cancers
M.D. Anderson Cancer Center
 2012-04 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
NCT02277457 WITHDRAWN
Non-Small Cell Lung Cancer
University of Michigan Rogel Cancer Center
 2015-09 EARLY_PHASE1
NCT01979536 COMPLETED
Anaplastic Large Cell Lymphoma, ALK-Positive; Ann Arbor Stage II Noncutaneous Childhood Anaplastic Large Cell Lymphoma; Ann Arbor Stage III Noncutaneous Childhood Anaplastic Large Cell Lymphoma; Ann Arbor Stage IV Noncutaneous Childhood Anaplastic Large Cell Lymphoma
National Cancer Institute (NCI)
 2013-11-13 PHASE2
NCT02584634 TERMINATED
Non-Small Cell Lung Cancer
Pfizer
 2015-12-18 PHASE1; PHASE2
NCT03874273 UNKNOWN
Inflammatory Myofibroblastic Tumor
Federal Research Institute of Pediatric Hematology, Oncology and Immunology
 2019-02-01 PHASE2; PHASE3
NCT03088930 COMPLETED
Lung Cancer, Nonsmall Cell
University of Colorado, Denver
 2017-12-13 PHASE2
NCT01531361 COMPLETED
Advanced Malignant Neoplasm; BRAF Gene Mutation; Metastatic Malignant Neoplasm; Recurrent Malignant Neoplasm; Refractory Malignant Neoplasm
M.D. Anderson Cancer Center
 2012-02-06 PHASE1
NCT01579994 COMPLETED
Advanced Lung Cancer
Memorial Sloan Kettering Cancer Center
 2012-04-16 PHASE1
NCT04641754 UNKNOWN
Non-small Cell Lung Cancer
Qilu Pharmaceutical Co., Ltd.
 2019-03-07 PHASE2
NCT02270034 COMPLETED
Glioblastoma Multiforme (Grade IV) of Cerebellum
Grupo Español de Investigación en Neurooncología
 2014-08-13 PHASE1
NCT02737501 COMPLETED
Non-small Cell Lung Cancer; Lung Cancer; Advanced Malignancies; Carcinoma
Ariad Pharmaceuticals
 2016-05-26 PHASE3
NCT02574078 COMPLETED
Non-Small Cell Lung Cancer
Bristol-Myers Squibb
 2015-11-23 PHASE1; PHASE2
NCT04439266 ACTIVE_NOT_RECRUITING
Advanced Lymphoma; Advanced Malignant Solid Neoplasm; Hematopoietic and Lymphoid Cell Neoplasm; Refractory Lymphoma; Refractory Malignant Solid Neoplasm; Refractory Multiple Myeloma
National Cancer Institute (NCI)
 2015-08-12 PHASE2
NCT04439253 ACTIVE_NOT_RECRUITING
Advanced Lymphoma; Advanced Malignant Solid Neoplasm; Hematopoietic and Lymphoid Cell Neoplasm; Refractory Lymphoma; Refractory Malignant Solid Neoplasm; Refractory Multiple Myeloma
National Cancer Institute (NCI)
 2015-08-12 PHASE2
NCT03052608 ACTIVE_NOT_RECRUITING
Carcinoma, Non-Small-Cell Lung
Pfizer
 2017-04-27 PHASE3
NCT03215693 UNKNOWN
Non-Small Cell Lung Cancer
Betta Pharmaceuticals Co., Ltd.
 2017-09-28 PHASE2
NCT03707847 UNKNOWN
ALK-Positive Anaplastic Large Cell Lymphoma
Mingzhi Zhang
 2018-10-01 PHASE4
NCT02836847 UNKNOWN
Cholangiocarcinoma of the Extrahepatic Bile Duct; Gallbladder Cancer
Shanghai Jiao Tong University School of Medicine
 2016-07 PHASE2
NCT03978143 COMPLETED
Healthy Volunteers
Pfizer
 2019-06-12 PHASE1
NCT02612194 TERMINATED
Urinary Bladder Neoplasms; Ureteral Neoplasms; Urethral Neoplasms
Wake Forest University Health Sciences
 2016-09-27 PHASE2
NCT02223819 COMPLETED
Uveal Melanoma
Columbia University
 2015-03 PHASE2
NCT04148066 Completed
Carcinoma Non-Small-Cell Lung
The Netherlands Cancer Institute|Roche Pharma AG
 2019-07-17 Not Applicable
NCT02034981 COMPLETED
Hematologic Cancers; Solid Tumors; Metastatic Cancer
UNICANCER
 2013-08 PHASE2
NCT03947385 Recruiting
Metastatic Uveal Melanoma|Cutaneous Melanoma|Colorectal Cancer|Other Solid Tumors
IDEAYA Biosciences
 2019-06-28 Phase 1|Phase 2
NCT01744652 COMPLETED
Advanced Cancers
M.D. Anderson Cancer Center
 2013-03 PHASE1
NCT03672643 Terminated
ALK or ROS1-positive NSCLC
Pfizer
 2019-01-28 Phase 4
NCT00939770 COMPLETED
Recurrent Childhood Anaplastic Large Cell Lymphoma; Recurrent Malignant Solid Neoplasm; Recurrent Neuroblastoma; Refractory Anaplastic Large Cell Lymphoma; Refractory Malignant Solid Neoplasm; Refractory Neuroblastoma
Children's Oncology Group
 2009-09-21 PHASE1; PHASE2
NCT01606878 COMPLETED
Childhood Solid Neoplasm; Recurrent Childhood Anaplastic Large Cell Lymphoma; Recurrent Neuroblastoma
Children's Oncology Group
 2013-04-29 PHASE1
NCT02183870 COMPLETED
Lung Cancer; Adenocarcinoma; NSCLC
University of Cologne
 2014-05 PHASE2
NCT01822496 TERMINATED
Stage III Non-Small Cell Lung Cancer AJCC v7; Stage IIIA Non-Small Cell Lung Cancer AJCC v7; Stage IIIB Non-Small Cell Lung Cancer AJCC v7
National Cancer Institute (NCI)
 2013-11-04 PHASE2
NCT02499614 UNKNOWN
Carcinoma, Non-Small-Cell Lung
Fondazione Ricerca Traslazionale
 2014-12 PHASE2
NCT02838420 COMPLETED
Anaplastic Lymphoma Kinase-positive Non-small Cell Lung Cancer
Hoffmann-La Roche
 2016-08-03 PHASE3
NCT01644773 COMPLETED
Diffuse Intrinsic Pontine Glioma; High-grade Glioma
St. Jude Children's Research Hospital
 2012-11-27 PHASE1
NCT02207504 COMPLETED
Castration-resistant Prostate Cancer
Dana-Farber Cancer Institute
 2014-08 PHASE1
NCT01685138 COMPLETED
Non-Small Cell Lung Cancer
Novartis Pharmaceuticals
 2012-12-20 PHASE2
NCT01524926 COMPLETED
Locally Advanced and/or Metastatic Anaplastic Large Cell Lymphoma; Locally Advanced and/or Metastatic Inflammatory Myofibroblastic Tumor; Locally Advanced and/or Metastatic Papillary Renal Cell Carcinoma Type 1; Locally Advanced and/or Metastatic Alveolar Soft Part Sarcoma; Locally Advanced and/or Metastatic Clear Cell Sarcoma; Locally Advanced and/or Metastatic Alveolar Rhabdomyosarcoma
European Organisation for Research and Treatment of Cancer - EORTC
 2012-09 PHASE2
NCT02511184 TERMINATED
ALK-positive Advanced NSCLC
Pfizer
 2015-10 PHASE1
NCT02487316 WITHDRAWN
Systemic Anaplastic Large-Cell Lymphoma
Jun Zhu
 2015-07 PHASE4
NCT02946359 UNKNOWN
Lung Adenocarcinoma Metastatic
Chinese PLA General Hospital
 2016-07 PHASE2
NCT03137134 COMPLETED
Healthy
Pfizer
 2017-06-20 PHASE1
NCT02040870 COMPLETED
Non-Small Cell Lung Cancer
Novartis Pharmaceuticals
 2014-03-07 PHASE1; PHASE2
NCT03439215 Unknown status
Carcinoma Non-Small-Cell Lung
Fondazione Ricerca Traslazionale|Clinical research technology Srl
 2017-06-13 Phase 2
NCT02074878 TERMINATED
Breast Cancer
Mothaffar Rimawi
 2014-06 PHASE1
NCT01998126 COMPLETED
Non-small Cell Lung Cancer
University of Utah
 2013-12-02 PHASE1
NCT01970865 COMPLETED
ALK-positive Non Small Cell Lung Cancer (NSCLC) and ROS1-positive NSCLC
Pfizer
 2014-01-08 PHASE1; PHASE2
NCT01999972 COMPLETED
Advanced Solid Tumors
Pfizer
 2014-02-26 PHASE1
NCT02075840 COMPLETED
Non-Small Cell Lung Cancer
Hoffmann-La Roche
 2014-08-19 PHASE3
NCT02604342 COMPLETED
Non-small Cell Lung Cancer
Hoffmann-La Roche
 2015-11-03 PHASE3
NCT01712217 COMPLETED
Non-small Cell Lung Cancer(NSCLC)
Astex Pharmaceuticals, Inc.
 2012-10 PHASE1; PHASE2
NCT02134912 TERMINATED
Adenocarcinoma of the Lung; Large Cell Lung Cancer; Recurrent Non-small Cell Lung Cancer; Stage IV Non-small Cell Lung Cancer
SWOG Cancer Research Network
 2014-08 PHASE2
NCT01576406 COMPLETED
Advanced Cancer
Pfizer
 2012-07 PHASE1
NCT01500824 WITHDRAWN
Non-Small Cell Lung Cancer
Pfizer
 2014-05 PHASE2
NCT01685060 COMPLETED
Non-Small Cell Lung Cancer
Novartis Pharmaceuticals
 2012-11-26 PHASE2
NCT02094573 COMPLETED
Carcinoma, Non-Small-Cell Lung
Ariad Pharmaceuticals
 2014-06-04 PHASE2
NCT01828112 COMPLETED
Non-Small Cell Lung Cancer
Novartis Pharmaceuticals
 2013-06-28 PHASE3
NCT02435108 COMPLETED
c-MET Positive Gastric Cancer
Samsung Medical Center
 2014-05-15 PHASE2
NCT01945021 COMPLETED
Non Small Cell Lung Cancer; ROS1 Proto Oncogene; Crizotinib
Pfizer
 2013-09-30 PHASE2
NCT01639001 COMPLETED
NSCLC (Non-small Cell Lung Cancer)
Pfizer
 2012-09-29 PHASE3
NCT01801111 COMPLETED
Non-Small-Cell Lung Carcinoma
Hoffmann-La Roche
 2013-06-20 PHASE1; PHASE2
NCT01871805 COMPLETED
Non-Small Cell Lung Cancer
Hoffmann-La Roche
 2013-09-30 PHASE1; PHASE2
NCT02006277 COMPLETED
Healthy
Pfizer
 2013-12 PHASE1
NCT01154140 COMPLETED
Non Squamous Lung Cancer
Pfizer
 2011-01-13 PHASE3
NCT01441388 WITHDRAWN
Carcinoma, Renal Cell; Glioblastoma; Carcinoma, Hepatocellular
Pfizer
 2011-12 PHASE1
NCT01419041 COMPLETED
Renal Impairment
Pfizer
 2011-11 PHASE1
NCT01549574 COMPLETED
Healthy
Pfizer
 2012-05 PHASE1
NCT01297595 COMPLETED
Healthy
Pfizer
 2011-03 PHASE1
NCT01154218 COMPLETED
Healthy
Pfizer
 2010-08 PHASE1
NCT01147055 COMPLETED
Healthy
Pfizer
 2010-07 PHASE1
NCT01168934 COMPLETED
Healthy
Pfizer
 2010-08 PHASE1
NCT01149785 COMPLETED
Healthy
Pfizer
 2010-07 PHASE1
NCT01125904 COMPLETED
Healthy
Pfizer
 2010-06 PHASE1

(data from https://clinicaltrials.gov, updated on 2023-02-21)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Crizotinib hydrochloride potently binds to c-Met, NPM-ALK, and ROS1 receptor tyrosine kinases, inhibiting their auto-phosphorylation and blocking downstream oncogenic signaling pathways such as STAT3. This biochemical inhibition suppresses proliferation and induces autophagy and apoptosis in targeted malignant cells, thereby inhibiting tumor growth in clinical conditions such as ALK- and ROS1-positive 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.