Clinical Trials

Vistusertib (AZD2014) has been evaluated in numerous Phase 1, Phase 1/2, and Phase 2 clinical trials across diverse oncology indications, including advanced solid tumors, glioblastoma multiforme, non-small cell lung cancer, diffuse large B-cell lymphoma, and hormone receptor-positive or triple-negative breast cancers. Sponsored by pharmaceutical companies such as AstraZeneca alongside major academic institutions like M.D. Anderson Cancer Center and the National Cancer Institute, these protocols encompass recruitment statuses ranging from active and completed to withdrawn or terminated studies.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT02813135 RECRUITING
Pediatric Cancer
Gustave Roussy, Cancer Campus, Grand Paris
 2016-08-03 PHASE1; PHASE2
NCT02208375 ACTIVE_NOT_RECRUITING
BRCA1 Mutation Carrier; BRCA2 Mutation Carrier; Endometrial Adenocarcinoma; Estrogen Receptor Negative; HER2/Neu Negative; High Grade Ovarian Serous Adenocarcinoma; Progesterone Receptor Negative; Recurrent Breast Carcinoma; Recurrent Fallopian Tube Carcinoma; Recurrent Ovarian Carcinoma; Recurrent Primary Peritoneal Carcinoma; Recurrent Uterine Corpus Carcinoma; Stage III Uterine Corpus Cancer AJCC v7; Stage IV Breast Cancer AJCC v6 and v7; Stage IV Uterine Corpus Cancer AJCC v7; Triple-Negative Breast Carcinoma
M.D. Anderson Cancer Center
 2014-11-11 PHASE1
NCT03334617 ACTIVE_NOT_RECRUITING
Non-Small Cell Lung Cancer
AstraZeneca
 2017-12-18 PHASE2
NCT02398747 COMPLETED
Advanced Solid Malignancies
AstraZeneca
 2015-03-17 PHASE1
NCT02664935 COMPLETED
Non-Small Cell Lung Cancer; Carcinoma, Squamous Cell; Adenocarcinoma
University of Birmingham
 2015-05-13 PHASE2
NCT02299999 ACTIVE_NOT_RECRUITING
Metastatic Breast Cancer
UNICANCER
 2014-04-07 PHASE2
NCT03071874 ACTIVE_NOT_RECRUITING
Meningioma
Massachusetts General Hospital
 2017-10-17 PHASE2
NCT02216786 COMPLETED
Estrogen Receptor Positive Breast Cancer
Queen Mary University of London
 2014-01-16 PHASE2
NCT03366103 TERMINATED
Metastatic Malignant Solid Neoplasm; Recurrent Lung Small Cell Carcinoma; Recurrent Malignant Solid Neoplasm; Refractory Malignant Solid Neoplasm; Stage III Lung Small Cell Carcinoma, by American Joint Committee on Cancer (AJCC) v7; Stage IIIA Lung Small Cell Carcinoma AJCC v7; Stage IIIB Lung Small Cell Carcinoma AJCC v7; Stage IV Lung Small Cell Carcinoma AJCC v7; Unresectable Solid Neoplasm
National Cancer Institute (NCI)
 2018-03-20 PHASE1; PHASE2
NCT02546661 ACTIVE_NOT_RECRUITING
Muscle Invasive Bladder Cancer
AstraZeneca
 2016-12-28 PHASE1
NCT02583542 UNKNOWN
Triple-Negative Breast Cancer; Squamous Cell Lung Cancer; Non-squamous Cell Lung Cancer With KRAS Mutations; Non-squamous Cell Lung Cancer With Wild-type KRAS
Queen Mary University of London
 2015-06 PHASE1; PHASE2
NCT03205046 TERMINATED
DLBCL; Richter Syndrome
Acerta Pharma BV
 2017-06-29 PHASE1; PHASE2
NCT02730923 UNKNOWN
Endometrial Carcinoma; Metastatic Carcinoma; Hormone Receptor Positive Tumor
Centre Leon Berard
 2016-04 PHASE1; PHASE2
NCT02831257 COMPLETED
Neurofibromatosis 2; Meningioma
Massachusetts General Hospital
 2016-08-31 PHASE2
NCT02780830 WITHDRAWN
Core: Relapsed or Refractory Diffuse Large B-Cell Lymphoma; Module 1: Non-GCB Diffuse Large B-Cell Lymphoma
AstraZeneca
 2016-06 PHASE1
NCT01884285 COMPLETED
Advanced Castrate-resistant Prostate Cancer CRPC; Squamous Non-Small Cell Lung Cancer sqNSCLC; Triple Negative Breast Cancer TNBC
AstraZeneca
 2013-07-09 PHASE1
NCT02619864 COMPLETED
Glioblastoma Multiforme
Canadian Cancer Trials Group
 2016-12-22 PHASE1
NCT02117167 COMPLETED
Non-small Cell Lung Cancer Metastatic
UNICANCER
 2014-04-23 PHASE2
NCT03061708 TERMINATED
Stomach Neoplasms
Samsung Medical Center
 2017-02-01 PHASE2
NCT03082833 TERMINATED
Cancer of Stomach
Samsung Medical Center
 2017-02-01 PHASE2
NCT03166176 WITHDRAWN
Solid Tumor
Samsung Medical Center
 2018-03 PHASE2
NCT02449655 TERMINATED
Advanced Gastric Adenocarcinoma
Samsung Medical Center
 2015-02-12 PHASE2
NCT03166904 WITHDRAWN
Solid Tumor
Samsung Medical Center
 2018-03 PHASE2
NCT03106155 TERMINATED
Small Cell Lung Cancer
Samsung Medical Center
 2017-08-02 PHASE2
NCT02599714 COMPLETED
Advanced and Metastatic Breast Cancer
AstraZeneca
 2015-12-07 PHASE1
NCT02193633 COMPLETED
Advanced Cancer
Royal Marsden NHS Foundation Trust
 2013-04-26 PHASE1
NCT02752204 COMPLETED
Diffuse Large B-Cell Lymphoma
University of Birmingham
 2015-10 PHASE2
NCT02403895 TERMINATED
Squamous Non Small Cell Lung Cancer
AstraZeneca
 2015-04-15 PHASE2
NCT02640755 COMPLETED
Solid Malignancies
AstraZeneca
 2016-01-28 PHASE1
NCT02064608 COMPLETED
Prostate Cancer
Cambridge University Hospitals NHS Foundation Trust
 2014-10 PHASE1
NCT02619864 Completed
Glioblastoma Multiforme
Canadian Cancer Trials Group|AstraZeneca
 2016-12-22 Phase 1
NCT01597388 COMPLETED
Advanced Metastatic Breast Cancer
AstraZeneca
 2012-05-08 PHASE1
NCT02780830 Withdrawn
Core: Relapsed or Refractory Diffuse Large B-Cell Lymphoma|Module 1: Non-GCB Diffuse Large B-Cell Lymphoma
AstraZeneca
 2016-06 Phase 1
NCT02730923 Active not recruiting
Endometrial Carcinoma|Metastatic Carcinoma|Hormone Receptor Positive Tumor
Centre Leon Berard
 2016-04 Phase 1|Phase 2
NCT02599714 Completed
Advanced and Metastatic Breast Cancer
AstraZeneca
 2015-12-07 Phase 1
NCT02752204 Completed
Diffuse Large B-Cell Lymphoma
University of Birmingham|Bloodwise|AstraZeneca|Cancer Research UK
 2015-10 Phase 2
NCT01026402 COMPLETED
Advanced Solid Malignancies
AstraZeneca
 2009-12 PHASE1
NCT01793636 TERMINATED
Metastatic Clear Cell Renal Carcinoma
Queen Mary University of London
 2013-02 PHASE2

(data from https://clinicaltrials.gov, updated on 2026-07-10)

Check the Vistusertib (AZD2014) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Vistusertib (AZD2014) selectively inhibits both mTORC1 and mTORC2 complexes, suppressing the phosphorylation of downstream effectors 4EBP1, AKT (Ser473), and NDRG1 to block translation initiation and protein synthesis. This dual pathway blockade induces cell cycle arrest, autophagy, and apoptosis, which halts tumor cell proliferation and underpins its clinical evaluation in patients with advanced solid tumors, diffuse large B-cell lymphoma, and refractory breast 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.