Clinical Trials

Saracatinib (AZD0530) has been evaluated across numerous clinical trials spanning Early Phase 1 through Phase 3, encompassing solid malignancies—such as non-small cell lung cancer, ovarian cancer, and osteosarcoma—alongside non-oncological conditions including Alzheimer's disease, idiopathic pulmonary fibrosis, and fibrodysplasia ossificans progressiva. These studies are sponsored by pharmaceutical entities such as AstraZeneca, government bodies including the National Cancer Institute and National Institute of Neurological Disorders and Stroke, and academic medical centers. Recruitment statuses range from actively recruiting and active non-recruiting to completed, terminated, and withdrawn.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT04307953 ACTIVE_NOT_RECRUITING
Fibrodysplasia Ossificans Progressiva
Amsterdam UMC, location VUmc
2020-08-05 PHASE2
NCT04598919 ACTIVE_NOT_RECRUITING
Idiopathic Pulmonary Fibrosis (IPF)
National Jewish Health
2020-11-12 PHASE1; PHASE2
NCT03661125 UNKNOWN
Parkinson Disease Psychosis
King's College London
2019-04-11 EARLY_PHASE1
NCT04598919 Active not recruiting
Idiopathic Pulmonary Fibrosis (IPF)
National Jewish Health|Yale University|Icahn School of Medicine at Mount Sinai|AstraZeneca|National Center for Advancing Translational Sciences (NCATS)|Baylor University|International Center for Health Outcomes and Innovation Research
2020-11-12 Phase 1|Phase 2
NCT04307953 Recruiting
Fibrodysplasia Ossificans Progressiva
Amsterdam UMC location VUmc|Royal National Orthopaedic Hospital NHS Trust|Klinikum Garmisch-Patenkirchen|University of Oxford|Brigham and Women''s Hospital|AstraZeneca|Innovative Medicines Initiative
2020-08-05 Phase 2
NCT02737202 TERMINATED
Pulmonary Lymphangioleiomyomatosis
Baylor College of Medicine
2016-04 PHASE2
NCT02262026 COMPLETED
Alcoholism
Yale University
2014-11-01 PHASE1
NCT02955186 COMPLETED
Alcohol Drinking
Yale University
2017-05-09 PHASE2
NCT02167256 COMPLETED
Alzheimer's Disease
Yale University
2014-12 PHASE2
NCT01216176 COMPLETED
Breast Cancer
Joyce Marie Slingerland, MD
2008-10-21 PHASE1; PHASE2
NCT02085603 COMPLETED
Cancer
Sheffield Teaching Hospitals NHS Foundation Trust
2014-03 PHASE2
NCT00752206 TERMINATED
Osteosarcoma
Sarcoma Alliance for Research through Collaboration
2009-03 PHASE2
NCT02732587 COMPLETED
Alcohol Drinking
Yale University
2015-11 PHASE1
NCT02116712 COMPLETED
Pulmonary Lymphangioleiomyomatosis
Tony Eissa
2014-08 PHASE1
NCT01864655 COMPLETED
Alzheimer's Disease
Stephen M. Strittmatter
2013-07 PHASE1
NCT02085603 Completed
Cancer
Sheffield Teaching Hospitals NHS Foundation Trust|AstraZeneca
2014-03 Phase 2
NCT01864655 Completed
Alzheimer''s Disease
Stephen M. Strittmatter|National Institute of Neurological Disorders and Stroke (NINDS)|Yale University
2013-07 Phase 1
NCT00638937 COMPLETED
Recurrent Non-small Cell Lung Cancer; Stage IIIB Non-small Cell Lung Cancer; Stage IV Non-small Cell Lung Cancer
National Cancer Institute (NCI)
2008-02 PHASE2
NCT01196741 COMPLETED
Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Cancer
University College, London
2011-03 PHASE2; PHASE3
NCT01267266 TERMINATED
Hormone-resistant Prostate Cancer; Recurrent Prostate Cancer; Stage IV Prostate Cancer
National Cancer Institute (NCI)
2010-12 PHASE2
NCT00397878 TERMINATED
Adenocarcinoma of the Colon; Adenocarcinoma of the Rectum; Recurrent Colon Cancer; Recurrent Rectal Cancer; Stage IV Colon Cancer; Stage IV Rectal Cancer
National Cancer Institute (NCI)
2006-11 PHASE2
NCT00735917 COMPLETED
Adenocarcinoma of the Pancreas; Recurrent Pancreatic Cancer; Stage IV Pancreatic Cancer
National Cancer Institute (NCI)
2008-10 PHASE2
NCT00513435 COMPLETED
Metastatic Squamous Neck Cancer With Occult Primary Squamous Cell Carcinoma; Recurrent Metastatic Squamous Neck Cancer With Occult Primary; Recurrent Squamous Cell Carcinoma of the Hypopharynx; Recurrent Squamous Cell Carcinoma of the Larynx; Recurrent Squamous Cell Carcinoma of the Lip and Oral Cavity; Recurrent Squamous Cell Carcinoma of the Nasopharynx; Recurrent Squamous Cell Carcinoma of the Oropharynx; Recurrent Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity; Recurrent Verrucous Carcinoma of the Larynx; Recurrent Verrucous Carcinoma of the Oral Cavity; Stage III Squamous Cell Carcinoma of the Hypopharynx; Stage III Squamous Cell Carcinoma of the Larynx; Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity; Stage III Squamous Cell Carcinoma of the Nasopharynx; Stage III Squamous Cell Carcinoma of the Oropharynx; Stage III Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity; Stage III Verrucous Carcinoma of the Larynx; Stage III Verrucous Carcinoma of the Oral Cavity; Stage IV Squamous Cell Carcinoma of the Hypopharynx; Stage IV Squamous Cell Carcinoma of the Nasopharynx; Stage IVA Squamous Cell Carcinoma of the Larynx; Stage IVA Squamous Cell Carcinoma of the Lip and Oral Cavity; Stage IVA Squamous Cell Carcinoma of the Oropharynx; Stage IVA Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity; Stage IVA Verrucous Carcinoma of the Larynx; Stage IVA Verrucous Carcinoma of the Oral Cavity; Stage IVB Squamous Cell Carcinoma of the Larynx; Stage IVB Squamous Cell Carcinoma of the Lip and Oral Cavity; Stage IVB Squamous Cell Carcinoma of the Oropharynx; Stage IVB Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity; Stage IVB Verrucous Carcinoma of the Larynx; Stage IVB Verrucous Carcinoma of the Oral Cavity; Stage IVC Squamous Cell Carcinoma of the Larynx; Stage IVC Squamous Cell Carcinoma of the Lip and Oral Cavity; Stage IVC Squamous Cell Carcinoma of the Oropharynx; Stage IVC Squamous Cell Carcinoma of the Paranasal Sinus and Nasal Cavity; Stage IVC Verrucous Carcinoma of the Larynx; Stage IVC Verrucous Carcinoma of the Oral Cavity; Tongue Cancer
National Cancer Institute (NCI)
2007-07 PHASE2
NCT00559507 COMPLETED
Estrogen Receptor-negative Breast Cancer; Male Breast Cancer; Progesterone Receptor-negative Breast Cancer; Recurrent Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer; Stage IV Breast Cancer
National Cancer Institute (NCI)
2007-10 PHASE2
NCT00669019 COMPLETED
Recurrent Melanoma; Stage IIA Melanoma; Stage IIB Melanoma; Stage IIC Melanoma; Stage IV Melanoma
National Cancer Institute (NCI)
2006-07 PHASE2
NCT00704366 COMPLETED
Solid Tumor
AstraZeneca
2008-06 PHASE1
NCT01000896 WITHDRAWN
Cancer; Non Small Cell Lung Cancer; Epithelial Ovarian Cancer
AstraZeneca
2010-01 PHASE1
NCT00718809 TERMINATED
Invasive Thymoma and Thymic Carcinoma; Recurrent Thymoma and Thymic Carcinoma; Stage III Thymoma; Stage IVA Thymoma; Stage IVB Thymoma
National Cancer Institute (NCI)
2008-06 PHASE2
NCT00607594 COMPLETED
Adenocarcinoma of the Gastroesophageal Junction; Adenocarcinoma of the Stomach; Recurrent Gastric Cancer; Stage III Gastric Cancer; Stage III Esophageal Cancer; Stage IV Esophageal Cancer; Stage IV Gastric Cancer
National Cancer Institute (NCI)
2008-01 PHASE2
NCT00496028 COMPLETED
Neoplasms
AstraZeneca
2007-03 PHASE1
NCT00558272 COMPLETED
Breast Cancer; Prostate Cancer; Bone Neoplasms
AstraZeneca
2008-02 PHASE2
NCT01000896 Withdrawn
Cancer|Non Small Cell Lung Cancer|Epithelial Ovarian Cancer
AstraZeneca
2010-01 Phase 1
NCT00610714 COMPLETED
Ovarian Neoplasms; Ovarian Cancer
AstraZeneca
2008-04 PHASE2
NCT00265876 COMPLETED
Pancreatic Cancer
NCIC Clinical Trials Group
2006-04-26 PHASE1; PHASE2
NCT00659360 COMPLETED
Adult Fibrosarcoma; Adult Leiomyosarcoma; Adult Liposarcoma; Adult Malignant Fibrous Histiocytoma; Adult Rhabdomyosarcoma; Dermatofibrosarcoma Protuberans; Endometrial Stromal Sarcoma; Recurrent Adult Soft Tissue Sarcoma; Recurrent Uterine Sarcoma; Stage III Adult Soft Tissue Sarcoma; Stage III Uterine Sarcoma; Stage IV Adult Soft Tissue Sarcoma; Stage IV Uterine Sarcoma; Uterine Carcinosarcoma; Uterine Leiomyosarcoma
National Cancer Institute (NCI)
2008-02 PHASE2
NCT00528645 COMPLETED
Extensive Stage Small Cell Lung Cancer; Lung Metastases; Malignant Pleural Effusion; Recurrent Small Cell Lung Cancer
National Cancer Institute (NCI)
2007-11 PHASE2
NCT00513071 COMPLETED
Hormone-resistant Prostate Cancer; Recurrent Prostate Cancer
National Cancer Institute (NCI)
2007-08 PHASE2
NCT00475956 COMPLETED
Neoplasms
AstraZeneca
2007-05 PHASE1
NCT00853983 COMPLETED
Healthy
AstraZeneca
2009-03 PHASE1
NCT00771979 COMPLETED
Healthy
AstraZeneca
2008-11 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-09-02)

Check the Saracatinib (AZD0530) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Saracatinib reversibly binds to the ATP-binding pocket of Src and Bcr-Abl tyrosine kinases, preventing autophosphorylation and suppressing downstream intracellular signaling cascades to impair cellular proliferation and migration. This targeted enzymatic inhibition attenuates aberrant growth and tissue remodeling pathways, providing the mechanistic rationale for its clinical evaluation in solid malignancies such as non-small cell lung cancer and non-neoplastic diseases like idiopathic pulmonary fibrosis.

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>).

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