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 Recruitment statuses range from actively recruiting and active non-recruiting to completed, terminated, and withdrawn.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)
Mechanism and Biochemical Profile
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>).
- Saracatinib (AZD0530) Mechanism of Action: Fyn Inhibition in Neuronal Cell Research
- Saracatinib (AZD0530) Working Concentration | Cell Culture | Treatment
- Saracatinib (AZD0530) Solubility in DMSO
- Saracatinib (AZD0530) Stock Solution
- Saracatinib (AZD0530) Storage
- Saracatinib (AZD0530) Stability
- Saracatinib (AZD0530) Combination Database
- Saracatinib (AZD0530) Molecular Weight
- Saracatinib (AZD0530) SMILES
- Saracatinib (AZD0530) CAS Number
- Saracatinib (AZD0530) Chemical Structure (2D and 3D)
- Saracatinib (AZD0530) IC50 for Cell-based and Cell-free Assays
- Saracatinib (AZD0530) Cayman (11497)? Try a better option.
- Saracatinib (AZD0530) Tocris (7189)? Try a better option.
- Saracatinib (AZD0530) Sigma (SML3195)? Try a better option.
- Saracatinib (AZD0530) MedChemExpress (HY-10234)? Try a better option.
- Saracatinib (AZD0530) SDS|MSDS