Clinical Trials

Adavosertib (AZD1775) has been investigated in numerous clinical trials ranging from early phase I through phase II. These studies evaluate its efficacy in advanced solid neoplasms—including uterine carcinoma, esophageal adenocarcinoma, CCNE1-amplified tumors, and TP53-mutated or resistant ovarian cancer—alongside hematologic malignancies such as acute myeloid leukemia. Sponsored by academic medical centers and industry partners, including the National Cancer Institute, AstraZeneca, Dana-Farber Cancer Institute, and Merck Sharp & Dohme LLC, these protocols encompass active, completed, and terminated statuses.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT02813135 RECRUITING
Pediatric Cancer
Gustave Roussy, Cancer Campus, Grand Paris
2016-08-03 PHASE1; PHASE2
NCT02659241 ACTIVE_NOT_RECRUITING
Advanced Fallopian Tube Carcinoma; Advanced Ovarian Carcinoma; Advanced Primary Peritoneal Carcinoma; Carcinomatosis; Fallopian Tube High Grade Serous Adenocarcinoma; Ovarian High Grade Serous Adenocarcinoma; Primary Peritoneal High Grade Serous Adenocarcinoma; Stage III Fallopian Tube Cancer AJCC v7; Stage III Ovarian Cancer AJCC v6 and v7; Stage III Primary Peritoneal Cancer AJCC v7; Stage IIIA Fallopian Tube Cancer AJCC v7; Stage IIIA Ovarian Cancer AJCC v6 and v7; Stage IIIA Primary Peritoneal Cancer AJCC v7; Stage IIIB Fallopian Tube Cancer AJCC v7; Stage IIIB Ovarian Cancer AJCC v6 and v7; Stage IIIB Primary Peritoneal Cancer AJCC v7; Stage IIIC Fallopian Tube Cancer AJCC v7; Stage IIIC Ovarian Cancer AJCC v6 and v7; Stage IIIC Primary Peritoneal Cancer AJCC v7; Stage IV Fallopian Tube Cancer AJCC v6 and v7; Stage IV Ovarian Cancer AJCC v6 and v7; Stage IV Primary Peritoneal Cancer AJCC v7
M.D. Anderson Cancer Center
2016-02-04 EARLY_PHASE1
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
NCT03579316 ACTIVE_NOT_RECRUITING
Recurrent Fallopian Tube Carcinoma; Recurrent Ovarian Carcinoma; Recurrent Primary Peritoneal Carcinoma
M.D. Anderson Cancer Center
2018-12-07 PHASE2
NCT03284385 ACTIVE_NOT_RECRUITING
Clear Cell Renal Cell Carcinoma; Locally Advanced Clear Cell Renal Cell Carcinoma; Locally Advanced Malignant Solid Neoplasm; Metastatic Malignant Solid Neoplasm; Metastatic Renal Cell Carcinoma; Stage III Renal Cell Cancer AJCC v8; Stage IV Renal Cell Cancer AJCC v8
National Cancer Institute (NCI)
2019-01-29 PHASE2
NCT03385655 ACTIVE_NOT_RECRUITING
Prostate Cancer
Canadian Cancer Trials Group
2018-08-01 PHASE2
NCT04460937 ACTIVE_NOT_RECRUITING
Clinical Stage III Esophageal Adenocarcinoma AJCC v8; Clinical Stage III Esophageal Squamous Cell Carcinoma AJCC v8; Clinical Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8; Clinical Stage IV Esophageal Adenocarcinoma AJCC v8; Clinical Stage IV Esophageal Squamous Cell Carcinoma AJCC v8; Clinical Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8; Clinical Stage IVA Esophageal Adenocarcinoma AJCC v8; Clinical Stage IVA Esophageal Squamous Cell Carcinoma AJCC v8; Clinical Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8; Clinical Stage IVB Esophageal Adenocarcinoma AJCC v8; Clinical Stage IVB Esophageal Squamous Cell Carcinoma AJCC v8; Clinical Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8; Distal Esophagus Adenocarcinoma; Gastric Cardia Adenocarcinoma; Metastatic Esophageal Adenocarcinoma; Metastatic Esophageal Squamous Cell Carcinoma; Metastatic Gastroesophageal Junction Adenocarcinoma; Metastatic Malignant Neoplasm in the Brain; Metastatic Malignant Neoplasm in the Leptomeninges; Pathologic Stage III Esophageal Adenocarcinoma AJCC v8; Pathologic Stage III Esophageal Squamous Cell Carcinoma AJCC v8; Pathologic Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8; Pathologic Stage IIIA Esophageal Adenocarcinoma AJCC v8; Pathologic Stage IIIA Esophageal Squamous Cell Carcinoma AJCC v8; Pathologic Stage IIIA Gastroesophageal Junction Adenocarcinoma AJCC v8; Pathologic Stage IIIB Esophageal Adenocarcinoma AJCC v8; Pathologic Stage IIIB Esophageal Squamous Cell Carcinoma AJCC v8; Pathologic Stage IIIB Gastroesophageal Junction Adenocarcinoma AJCC v8; Pathologic Stage IV Esophageal Adenocarcinoma AJCC v8; Pathologic Stage IV Esophageal Squamous Cell Carcinoma AJCC v8; Pathologic Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8; Pathologic Stage IVA Esophageal Adenocarcinoma AJCC v8; Pathologic Stage IVA Esophageal Squamous Cell Carcinoma AJCC v8; Pathologic Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8; Pathologic Stage IVB Esophageal Adenocarcinoma AJCC v8; Pathologic Stage IVB Esophageal Squamous Cell Carcinoma AJCC v8; Pathologic Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8; Postneoadjuvant Therapy Stage III Esophageal Adenocarcinoma AJCC v8; Postneoadjuvant Therapy Stage III Esophageal Squamous Cell Carcinoma AJCC v8; Postneoadjuvant Therapy Stage III Gastroesophageal Junction Adenocarcinoma AJCC v8; Postneoadjuvant Therapy Stage IIIA Esophageal Adenocarcinoma AJCC v8; Postneoadjuvant Therapy Stage IIIA Esophageal Squamous Cell Carcinoma AJCC v8; Postneoadjuvant Therapy Stage IIIA Gastroesophageal Junction Adenocarcinoma AJCC v8; Postneoadjuvant Therapy Stage IIIB Esophageal Adenocarcinoma AJCC v8; Postneoadjuvant Therapy Stage IIIB Esophageal Squamous Cell Carcinoma AJCC v8; Postneoadjuvant Therapy Stage IIIB Gastroesophageal Junction Adenocarcinoma AJCC v8; Postneoadjuvant Therapy Stage IV Esophageal Adenocarcinoma AJCC v8; Postneoadjuvant Therapy Stage IV Esophageal Squamous Cell Carcinoma AJCC v8; Postneoadjuvant Therapy Stage IV Gastroesophageal Junction Adenocarcinoma AJCC v8; Postneoadjuvant Therapy Stage IVA Esophageal Adenocarcinoma AJCC v8; Postneoadjuvant Therapy Stage IVA Esophageal Squamous Cell Carcinoma AJCC v8; Postneoadjuvant Therapy Stage IVA Gastroesophageal Junction Adenocarcinoma AJCC v8; Postneoadjuvant Therapy Stage IVB Esophageal Adenocarcinoma AJCC v8; Postneoadjuvant Therapy Stage IVB Esophageal Squamous Cell Carcinoma AJCC v8; Postneoadjuvant Therapy Stage IVB Gastroesophageal Junction Adenocarcinoma AJCC v8; Unresectable Esophageal Adenocarcinoma; Unresectable Esophageal Carcinoma; Unresectable Esophageal Squamous Cell Carcinoma; Unresectable Gastroesophageal Junction Adenocarcinoma
National Cancer Institute (NCI)
2021-04-09 PHASE1
NCT05212025 WITHDRAWN
Pancreatic Cancer
James Cleary, MD, PhD
2022-06 PHASE2
NCT01164995 COMPLETED
Epithelial Ovarian Cancer
The Netherlands Cancer Institute
2010-07 PHASE2
NCT04197713 ACTIVE_NOT_RECRUITING
Advanced Malignant Solid Neoplasm; Metastatic Malignant Solid Neoplasm; Refractory Malignant Solid Neoplasm; Unresectable Malignant Solid Neoplasm
National Cancer Institute (NCI)
2020-06-30 PHASE1
NCT03253679 COMPLETED
Advanced Malignant Solid Neoplasm; Refractory Malignant Solid Neoplasm
National Cancer Institute (NCI)
2019-01-16 PHASE2
NCT04959266 TERMINATED
Advanced Solid Tumours
AstraZeneca
2021-06-28 PHASE1
NCT04590248 COMPLETED
Uterine Serous Carcinoma
AstraZeneca
2020-11-30 PHASE2
NCT03345784 TERMINATED
Cervical Carcinoma; Endometrioid Adenocarcinoma; Malignant Female Reproductive System Neoplasm; Recurrent Cervical Carcinoma; Stage I Uterine Corpus Cancer AJCC v7; Stage I Vaginal Cancer AJCC v6 and v7; Stage IA Uterine Corpus Cancer AJCC v7; Stage IB Cervical Cancer AJCC v6 and v7; Stage IB Uterine Corpus Cancer AJCC v7; Stage IB2 Cervical Cancer AJCC v6 and v7; Stage II Cervical Cancer AJCC v7; Stage II Uterine Corpus Cancer AJCC v7; Stage II Vaginal Cancer AJCC v6 and v7; Stage IIA Cervical Cancer AJCC v7; Stage IIB Cervical Cancer AJCC v6 and v7; Stage III Cervical Cancer AJCC v6 and v7; Stage III Uterine Corpus Cancer AJCC v7; Stage III Vaginal Cancer AJCC v6 and v7; Stage IIIA Cervical Cancer AJCC v6 and v7; Stage IIIA Uterine Corpus Cancer AJCC v7; Stage IIIB Cervical Cancer AJCC v6 and v7; Stage IIIB Uterine Corpus Cancer AJCC v7; Stage IIIC Uterine Corpus Cancer AJCC v7; Vaginal Carcinoma
National Cancer Institute (NCI)
2018-05-29 PHASE1
NCT04949425 TERMINATED
Advanced Solid Tumours
AstraZeneca
2021-09-13 PHASE1
NCT02101775 ACTIVE_NOT_RECRUITING
Ovarian Brenner Tumor; Ovarian Clear Cell Cystadenocarcinoma; Ovarian Endometrioid Adenocarcinoma; Ovarian Malignant Mixed Mesodermal (Mullerian) Tumor; Ovarian Mucinous Cystadenocarcinoma; Ovarian Seromucinous Carcinoma; Ovarian Serous Cystadenocarcinoma; Ovarian Serous Surface Papillary Adenocarcinoma; Ovarian Undifferentiated Carcinoma; Recurrent Fallopian Tube Carcinoma; Recurrent Ovarian Carcinoma; Recurrent Primary Peritoneal Carcinoma
National Cancer Institute (NCI)
2014-07-21 PHASE2
NCT05008913 TERMINATED
Advanced Solid Tumors
AstraZeneca
2021-10-01 PHASE1
NCT04462952 COMPLETED
Advanced Solid Tumours
AstraZeneca
2020-06-24 PHASE1
NCT01849146 COMPLETED
Glioblastoma; Recurrent Glioblastoma
National Cancer Institute (NCI)
2013-10-24 PHASE1
NCT01827384 COMPLETED
Advanced Malignant Solid Neoplasm
National Cancer Institute (NCI)
2014-01-07 PHASE2
NCT01922076 COMPLETED
Anaplastic Astrocytoma; Anaplastic Oligoastrocytoma; Diffuse Intrinsic Pontine Glioma; Diffuse Midline Glioma, H3 K27M-Mutant; Glioblastoma; Gliosarcoma
National Cancer Institute (NCI)
2013-09-03 PHASE1
NCT02095132 COMPLETED
Central Nervous System Embryonal Tumor With Rhabdoid Features; Central Nervous System Embryonal Tumor, Not Otherwise Specified; Central Nervous System Ganglioneuroblastoma; Embryonal Tumor With Multilayered Rosettes, C19MC-Altered; Pineoblastoma; Primary Central Nervous System Neoplasm; Recurrent Childhood Central Nervous System Embryonal Neoplasm; Recurrent Malignant Solid Neoplasm; Recurrent Medulloblastoma; Recurrent Neuroblastoma; Recurrent Rhabdomyosarcoma; Refractory Malignant Solid Neoplasm; Refractory Medulloblastoma; Refractory Neuroblastoma; Refractory Rhabdomyosarcoma
National Cancer Institute (NCI)
2014-03-28 PHASE1; PHASE2
NCT03330847 ACTIVE_NOT_RECRUITING
Metastatic Triple Negative Breast Cancer
AstraZeneca
2018-03-07 PHASE2
NCT04439227 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)
2017-03-24 PHASE2
NCT01748825 COMPLETED
Solid Tumors
National Cancer Institute (NCI)
2012-12-19 PHASE1
NCT02617277 COMPLETED
Advanced Solid Tumours
AstraZeneca
2015-12-28 PHASE1
NCT03253679 Completed
Advanced Malignant Solid Neoplasm|Refractory Malignant Solid Neoplasm
National Cancer Institute (NCI)
2019-01-16 Phase 2
NCT02272790 COMPLETED
Ovarian, Fallopian Tube, Peritoneal Cancer, P53 Mutation
AstraZeneca
2015-01-30 PHASE2
NCT03668340 Active not recruiting
Uterine Cancer
Dana-Farber Cancer Institute|AstraZeneca
2018-10-22 Phase 2
NCT02037230 COMPLETED
Adenocarcinoma of the Pancreas
University of Michigan Rogel Cancer Center
2014-01 PHASE1; PHASE2
NCT02381548 TERMINATED
Acute Myeloid Leukemia; Acute Myeloid Leukemia Post Cytotoxic Therapy; Blast Phase Chronic Myeloid Leukemia, BCR-ABL1 Positive; Myelodysplastic Syndrome; Recurrent Adult Acute Myeloid Leukemia; Recurrent Chronic Myeloid Leukemia, BCR-ABL1 Positive; Refractory Acute Myeloid Leukemia; Refractory Chronic Myeloid Leukemia, BCR-ABL1 Positive; Secondary Acute Myeloid Leukemia
National Cancer Institute (NCI)
2015-08-18 PHASE1
NCT03028766 Completed
Hypopharynx Squamous Cell Carcinoma|Oral Cavity Squamous Cell Carcinoma|Larynx Cancer
University of Birmingham|AstraZeneca|Cancer Research UK
2017-06-22 Phase 1
NCT01357161 COMPLETED
Ovarian Cancer
Merck Sharp & Dohme LLC
2011-07-26 PHASE2
NCT02196168 TERMINATED
Recurrent Hypopharyngeal Squamous Cell Carcinoma; Recurrent Laryngeal Squamous Cell Carcinoma; Recurrent Laryngeal Verrucous Carcinoma; Recurrent Lip and Oral Cavity Squamous Cell Carcinoma; Recurrent Metastatic Squamous Cell Carcinoma in the Neck With Occult Primary; Recurrent Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma; Recurrent Oral Cavity Verrucous Carcinoma; Recurrent Oropharyngeal Squamous Cell Carcinoma; Squamous Cell Carcinoma Metastatic in the Neck With Occult Primary; Stage IV Hypopharyngeal Squamous Cell Carcinoma; Stage IVA Laryngeal Squamous Cell Carcinoma; Stage IVA Laryngeal Verrucous Carcinoma; Stage IVA Lip and Oral Cavity Squamous Cell Carcinoma; Stage IVA Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma; Stage IVA Oral Cavity Verrucous Carcinoma; Stage IVA Oropharyngeal Squamous Cell Carcinoma; Stage IVB Laryngeal Squamous Cell Carcinoma; Stage IVB Laryngeal Verrucous Carcinoma; Stage IVB Lip and Oral Cavity Squamous Cell Carcinoma; Stage IVB Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma; Stage IVB Oral Cavity Verrucous Carcinoma; Stage IVB Oropharyngeal Squamous Cell Carcinoma; Stage IVC Laryngeal Squamous Cell Carcinoma; Stage IVC Laryngeal Verrucous Carcinoma; Stage IVC Lip and Oral Cavity Squamous Cell Carcinoma; Stage IVC Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma; Stage IVC Oral Cavity Verrucous Carcinoma; Stage IVC Oropharyngeal Squamous Cell Carcinoma; Tongue Carcinoma
National Cancer Institute (NCI)
2014-03 PHASE2
NCT00648648 COMPLETED
Solid Tumors
Merck Sharp & Dohme LLC
2008-02-25 PHASE1
NCT01047007 TERMINATED
Solid Tumors
Merck Sharp & Dohme LLC
2010-01-18 PHASE1
NCT01076400 TERMINATED
Cervical Cancer
Merck Sharp & Dohme LLC
2010-05-31 PHASE1; PHASE2

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

Check the Adavosertib (AZD1775, MK-1775) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Adavosertib selectively binds to and inhibits Wee1 kinase, preventing the phosphorylation of cyclin-dependent kinase 1 (CDC2) at Tyr15 and abrogating the G2 DNA damage checkpoint. Consequently, this target blockade forces p53-deficient tumor cells with DNA damage into premature mitosis and apoptosis, resulting in clinical tumor growth inhibition across advanced solid neoplasms and ovarian cancers.

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.