Numerous clinical trials evaluate the therapeutic profile of capivasertib (AZD5363) across Phase 1, Phase 2, and Phase 3 studies, alongside early pharmacokinetic assessments in healthy volunteers. These evaluations target various oncological conditions, predominantly advanced solid tumors, metastatic castrate-resistant prostate cancer, and estrogen receptor-positive or locally advanced and metastatic breast cancer subtypes. Supported by industry sponsors such as AstraZeneca and academic institutions including Memorial Sloan Kettering Cancer Center and the Royal Marsden NHS Foundation Trust, recruitment statuses across the trial portfolio range from active and recruiting to completed, withdrawn, or terminated.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07802626 | NOT_YET_RECRUITING | HR Positive/HER-2 Negative Breast Cancer |
SWOG Cancer Research Network |
2026-10-30 | PHASE3 |
| NCT07294677 | RECRUITING | Leukemia; Lymphoma |
University of Chicago |
2026-03-17 | PHASE1; PHASE2 |
| NCT07175415 | NOT_YET_RECRUITING | Acute Lymphoblastic Leukemia; Lymphoblastic Lymphoma (Precursor B-Lymphoblastic Lymphoma/Leukaemia) Recurrent; Lymphoblastic Lymphoma (Precursor B-Lymphoblastic Lymphoma/Leukaemia) Refractory; Lymphoblastic Lymphoma (Precursor T-Lymphoblastic Lymphoma/Leukaemia) Recurrent; Lymphoblastic Lymphoma (Precursor T-Lymphoblastic Lymphoma/Leukaemia) Refractory |
Princess Maxima Center for Pediatric Oncology |
2026-10-01 | PHASE1; PHASE2 |
| NCT02813135 | RECRUITING | Pediatric Cancer |
Gustave Roussy, Cancer Campus, Grand Paris |
2016-08-03 | PHASE1; PHASE2 |
| NCT07281833 | RECRUITING | Breast Cancer; HR-positive Breast Cancer; Advanced Breast Cancer; Metastatic Breast Cancer; HER2-negative Breast Cancer |
Women's Cancer Study Group GmbH |
2025-11-27 | PHASE3 |
| NCT07793578 | NOT_YET_RECRUITING | Advanced Urothelial Carcinoma |
VA Office of Research and Development |
2026-10-01 | PHASE1; PHASE2 |
| NCT07486648 | NOT_YET_RECRUITING | Lung Cancer (NSCLC); Lung Cancer (Non-Small Cell); Advanced Non-small-cell Lung Cancer |
Shanxi Province Cancer Hospital |
2026-05-15 | 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 |
| NCT06982521 | RECRUITING | PIK3CA Mutation; HER2- Negative Breast Cancer; Hormone Receptor Positive Tumor; Breast Cancer; Metastatic Breast Cancer; Advanced Breast Cancer |
Relay Therapeutics, Inc. |
2025-08-26 | PHASE3 |
| NCT05039801 | RECRUITING | Advanced Endometrial Carcinoma; Advanced Head and Neck Squamous Cell Carcinoma; Advanced Malignant Solid Neoplasm; Advanced Melanoma; Advanced Ovarian Clear Cell Adenocarcinoma; Chondrosarcoma; Clinical Stage III Cutaneous Melanoma AJCC v8; Clinical Stage IV Cutaneous Melanoma AJCC v8; Pathologic Stage III Cutaneous Melanoma AJCC v8; Pathologic Stage IIIA Cutaneous Melanoma AJCC v8; Pathologic Stage IIIB Cutaneous Melanoma AJCC v8; Pathologic Stage IIIC Cutaneous Melanoma AJCC v8; Pathologic Stage IIID Cutaneous Melanoma AJCC v8; Pathologic Stage IV Cutaneous Melanoma AJCC v8; Recurrent Ovarian High Grade Serous Adenocarcinoma; Refractory Endometrial Carcinoma; Refractory Head and Neck Squamous Cell Carcinoma; Refractory Melanoma; Refractory Ovarian Clear Cell Adenocarcinoma; Refractory Ovarian High Grade Serous Adenocarcinoma; Stage III Ovarian Cancer AJCC v8; Stage III Uterine Corpus Cancer AJCC v8; Stage IIIA Ovarian Cancer AJCC v8; Stage IIIA Uterine Corpus Cancer AJCC v8; Stage IIIA1 Ovarian Cancer AJCC v8; Stage IIIA2 Ovarian Cancer AJCC v8; Stage IIIB Ovarian Cancer AJCC v8; Stage IIIB Uterine Corpus Cancer AJCC v8; Stage IIIC Ovarian Cancer AJCC v8; Stage IIIC Uterine Corpus Cancer AJCC v8; Stage IIIC1 Uterine Corpus Cancer AJCC v8; Stage IIIC2 Uterine Corpus Cancer AJCC v8; Stage IV Ovarian Cancer AJCC v8; Stage IV Uterine Corpus Cancer AJCC v8; Stage IVA Ovarian Cancer AJCC v8; Stage IVA Uterine Corpus Cancer AJCC v8; Stage IVB Ovarian Cancer AJCC v8; Stage IVB Uterine Corpus Cancer AJCC v8 |
M.D. Anderson Cancer Center |
2021-09-30 | PHASE1 |
| NCT07287917 | RECRUITING | Melanoma (Skin Cancer); HER2-low Hormone Receptor Positive Breast Cancer |
Aminex Therapeutics, Inc. |
2026-01-26 | PHASE1; PHASE2 |
| NCT06764186 | ACTIVE_NOT_RECRUITING | Locally Advanced or Metastatic Breast Cancer |
AstraZeneca |
2025-01-07 | PHASE3 |
| NCT04862663 | ACTIVE_NOT_RECRUITING | Locally Advanced (Inoperable) or Metastatic Breast Cancer |
AstraZeneca |
2021-05-10 | PHASE3 |
| NCT04812366 | RECRUITING | Prostate Cancer |
University of British Columbia |
2021-09-21 | PHASE2 |
| NCT05593497 | RECRUITING | High-Risk Prostate Cancer |
VA Office of Research and Development |
2024-05-31 | PHASE2 |
| NCT07426822 | RECRUITING | Metastatic HR+/HER2- Breast Cancer |
Maryam Lustberg |
2026-08-15 | PHASE2 |
| NCT02523014 | RECRUITING | Intracranial Meningioma; Recurrent Meningioma; NF2 Gene Mutation |
Alliance for Clinical Trials in Oncology |
2015-09-28 | PHASE2 |
| 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 |
| NCT03772561 | RECRUITING | Solid Tumor, Adult |
National University Hospital, Singapore |
2018-12-03 | PHASE1 |
| NCT05563220 | ACTIVE_NOT_RECRUITING | Breast Cancer; Metastatic Breast Cancer |
Stemline Therapeutics, Inc. |
2023-01-24 | PHASE1; PHASE2 |
| NCT03903835 | RECRUITING | Metastatic Castration-resistant Prostate Cancer (mCRPC); Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) |
Karolinska Institutet |
2019-02-01 | PHASE3 |
| NCT07343960 | RECRUITING | Moderate Hepatic Impairment |
AstraZeneca |
2026-01-06 | PHASE1 |
| NCT06635447 | ACTIVE_NOT_RECRUITING | Breast Cancer |
AstraZeneca |
2024-09-26 | PHASE3 |
| NCT07241065 | COMPLETED | Healthy Participants |
AstraZeneca |
2026-03-19 | PHASE1 |
| NCT06607757 | RECRUITING | CCCA Assessed by Ki67 Drop Below <2.7% From Baseline |
GBG Forschungs GmbH |
2024-12-04 | PHASE2 |
| NCT03997123 | ACTIVE_NOT_RECRUITING | Triple Negative Breast Neoplasms |
AstraZeneca |
2019-06-25 | PHASE3 |
| NCT05348577 | ACTIVE_NOT_RECRUITING | Prostate Cancer |
AstraZeneca |
2022-03-25 | PHASE3 |
| NCT07088913 | COMPLETED | Healthy Participants |
AstraZeneca |
2025-07-28 | PHASE1 |
| NCT06613516 | WITHDRAWN | Breast Cancer; Oestrogen Receptor Positive Breast Cancer |
Imperial College London |
2025-02-01 | PHASE2 |
| NCT05720260 | RECRUITING | Premenopausal Breast Cancer; Metastatic Breast Cancer; ER Positive Breast Cancer |
National Taiwan University Hospital |
2023-01-17 | PHASE2 |
| NCT03660826 | ACTIVE_NOT_RECRUITING | Endometrial Adenocarcinoma; Endometrial Mixed Cell Adenocarcinoma; Endometrial Serous Adenocarcinoma; Endometrial Undifferentiated Carcinoma; Endometrioid Adenocarcinoma; Stage IV Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8 |
National Cancer Institute (NCI) |
2018-09-27 | PHASE2 |
| NCT03742102 | ACTIVE_NOT_RECRUITING | Triple Negative Breast Neoplasms |
AstraZeneca |
2018-12-21 | PHASE1; PHASE2 |
| NCT03801369 | TERMINATED | Anatomic Stage IV Breast Cancer AJCC v8; Metastatic Triple-Negative Breast Carcinoma |
Gordon Mills, MD, PhD |
2018-12-12 | PHASE2 |
| NCT04493853 | ACTIVE_NOT_RECRUITING | Hormone-Sensitive Prostate Cancer |
AstraZeneca |
2020-07-13 | PHASE3 |
| NCT03616587 | ACTIVE_NOT_RECRUITING | ER+ HER2- Advanced Breast Cancer |
AstraZeneca |
2018-10-11 | PHASE1 |
| NCT02664935 | COMPLETED | Non-Small Cell Lung Cancer; Carcinoma, Squamous Cell; Adenocarcinoma |
University of Birmingham |
2015-05-13 | PHASE2 |
| NCT05008055 | COMPLETED | Relapsed or Refractory B-cell Non-Hodgkin Lymphoma |
AstraZeneca |
2021-11-03 | PHASE2 |
| NCT04556773 | ACTIVE_NOT_RECRUITING | Metastatic Breast Cancer |
AstraZeneca |
2020-12-17 | PHASE1 |
| NCT04305496 | ACTIVE_NOT_RECRUITING | Locally Advanced (Inoperable) or Metastatic Breast Cancer |
AstraZeneca |
2020-04-16 | PHASE3 |
| NCT03310541 | COMPLETED | Breast Cancer; Prostate Cancer; Advanced Solid Tumors |
Memorial Sloan Kettering Cancer Center |
2017-10-11 | PHASE1 |
| NCT04958226 | COMPLETED | Solid Tumour |
AstraZeneca |
2021-10-15 | PHASE1 |
| NCT02299999 | ACTIVE_NOT_RECRUITING | Metastatic Breast Cancer |
UNICANCER |
2014-04-07 | PHASE2 |
| NCT03182634 | UNKNOWN | Advanced Breast Cancer |
Institute of Cancer Research, United Kingdom |
2016-12-15 | PHASE2 |
| NCT04742036 | COMPLETED | Advanced Solid Tumours |
AstraZeneca |
2021-02-22 | PHASE1 |
| NCT05419401 | COMPLETED | Healthy Volunteer |
AstraZeneca |
2022-04-11 | PHASE1 |
| NCT04944771 | COMPLETED | Solid and Hematological Malignancies |
AstraZeneca |
2021-07-26 | PHASE1 |
| NCT04087174 | COMPLETED | Prostate Cancer |
AstraZeneca |
2019-08-05 | PHASE1 |
| NCT04712396 | COMPLETED | Healthy Volunteers (Intended Indication: Metastatic Patients With Triple Negative or HR+ Breast Cancer, or Hormone Sensitive Prostate Cancer) |
AstraZeneca |
2021-02-01 | PHASE1 |
| NCT02121639 | COMPLETED | Prostate Cancer |
University Hospital Southampton NHS Foundation Trust |
2014-01-29 | PHASE1; PHASE2 |
| NCT02525068 | UNKNOWN | Adenocarcinoma of the Prostate |
Institute of Cancer Research, United Kingdom |
2014-12 | PHASE2 |
| NCT02576444 | TERMINATED | Cancer |
Joseph Paul Eder |
2015-11 | PHASE2 |
| NCT04439123 | 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) |
2016-05-31 | PHASE2 |
| NCT02451956 | COMPLETED | Advanced Gastric Cancer |
Samsung Medical Center |
2015-01-07 | PHASE2 |
| NCT01226316 | COMPLETED | Advanced Solid Malignancy; Safety and Tolerability; Pharmacokinetics; Pharmacodynamics; Tumour Response; Advanced or Metastatic Breast Cancer; Ovarian Cancer; Cervical Cancer; Endometrial Cancer; PIK3CA; AKT1; PTEN; ER Positive; HER2 Positive |
AstraZeneca |
2010-12-01 | PHASE1 |
| NCT01992952 | ACTIVE_NOT_RECRUITING | Estrogen Receptor Positive Breast Cancer |
Velindre NHS Trust |
2014-05-07 | PHASE1; PHASE2 |
| NCT02117167 | COMPLETED | Non-small Cell Lung Cancer Metastatic |
UNICANCER |
2014-04-23 | PHASE2 |
| NCT02449655 | TERMINATED | Advanced Gastric Adenocarcinoma |
Samsung Medical Center |
2015-02-12 | PHASE2 |
| NCT03310541 | Completed | Breast Cancer|Prostate Cancer|Advanced Solid Tumors |
Memorial Sloan Kettering Cancer Center |
2017-10-11 | Phase 1 |
| NCT02423603 | COMPLETED | Metastatic Breast Cancer |
Queen Mary University of London |
2014-05-14 | PHASE2 |
| NCT02077569 | COMPLETED | Invasive Breast Cancer |
University of Nottingham |
2014-01 | PHASE2 |
| NCT01625286 | COMPLETED | Advanced or Metastatic Breast Cancer; ER+ve Advanced or Metastatic Breast Cancer |
AstraZeneca |
2012-10-03 | PHASE1; PHASE2 |
| NCT02338622 | COMPLETED | Advanced Cancer |
Royal Marsden NHS Foundation Trust |
2014-03-31 | PHASE1 |
| NCT01895946 | COMPLETED | Advanced Solid Malignancy,; Safety and Tolerability,; Pharmacokinetics, Pharmacodynamics,; Tumour Response, |
AstraZeneca |
2013-12 | PHASE1 |
| NCT01353781 | COMPLETED | Advanced Solid Malignancy; Advanced Solid Tumor |
AstraZeneca |
2011-06 | PHASE1 |
| NCT01692262 | COMPLETED | Metastatic Castrate-Resistant Prostate Cancer (mCRPC),; Efficacy,; Safety and Tolerability,; Pharmacokinetics,; Pharmacodynamics,; Tumour Response. |
AstraZeneca |
2012-11 | PHASE1 |
| NCT01992952 | Active not recruiting | Estrogen Receptor Positive Breast Cancer |
Velindre NHS Trust|AstraZeneca|Cenduit LLC|Covance|Cardiff and Vale University Health Board |
2014-05 | Phase 1|Phase 2 |
| NCT02338622 | Completed | Advanced Cancer |
Royal Marsden NHS Foundation Trust|Institute of Cancer Research United Kingdom|AstraZeneca |
2014-03-31 | Phase 1 |
| NCT02121639 | Completed | Prostate Cancer |
University Hospital Southampton NHS Foundation Trust|AstraZeneca|Cancer Research UK |
2014-01-29 | Phase 1|Phase 2 |
| NCT02077569 | Completed | Invasive Breast Cancer |
University of Nottingham|AstraZeneca|Cancer Research UK|National Cancer Research Network |
2014-01 | Phase 2 |
| NCT01692262 | Completed | Metastatic Castrate-Resistant Prostate Cancer (mCRPC)|Efficacy|Safety and Tolerability|Pharmacokinetics|Pharmacodynamics|Tumour Response. |
AstraZeneca |
2012-11 | Phase 1 |
(data from https://clinicaltrials.gov, updated on 2026-09-03)
Check the
AZD5363 (Capivasertib)
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
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>).
- AZD5363 (Capivasertib) Mechanism of Action: AKT Inhibition in Breast Cancer Cells Research
- AZD5363 (Capivasertib): Selectivity & Specificity
- AZD5363 (Capivasertib) Working Concentration | Cell Culture | Treatment
- AZD5363 (Capivasertib) Solubility in DMSO
- AZD5363 (Capivasertib) Stock Solution
- AZD5363 (Capivasertib) Storage
- AZD5363 (Capivasertib) Stability
- AZD5363 (Capivasertib) Combination Database
- AZD5363 (Capivasertib) Molecular Weight
- AZD5363 (Capivasertib) SMILES
- AZD5363 (Capivasertib) CAS Number
- AZD5363 (Capivasertib) Chemical Structure (2D and 3D)
- AZD5363 (Capivasertib) IC50 for Cell-based and Cell-free Assays
- AZD5363 (Capivasertib) Sigma (AMBH2D6FA35F)? Try a better option.
- AZD5363 (Capivasertib) MedChemExpress (HY-15431)? Try a better option.
- AZD5363 (Capivasertib) Cayman (15406)? Try a better option.
- AZD5363 (Capivasertib) Tocris (6978)? Try a better option.
- AZD5363 (Capivasertib) Abcam (ab282438)? Try a better option.
- AZD5363 (Capivasertib) SDS｜MSDS
Note: Technical data last updated: Sep 1, 2026.