14 completed, 10 active not recruiting, 5 recruiting, 3 terminated. 20 Phase 2, 16 Phase 1, 2 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 20 | Active not recruiting 6, Completed 6, Recruiting 3, Terminated 3, Unknown 2 |
| Phase 1 | 16 | Completed 9, Active not recruiting 4, Recruiting 3 |
| Phase 3 | 2 | Active not recruiting 2 |
Follow AZD5363: new trials by email Literature Review of AZD5363 trials Research Report on AZD5363
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| A Phase I Study to Investigate the Pharmacokinetics and Safety of Capivasertib in Participants With Moderate Hepatic Impairment Capivasertib - Moderate Hepatic Impairment | Phase 1 | Recruiting | AstraZeneca | 20 | 2026-01-06 | 2026-09-09 |
| A Study to Investigate the Effect of Capivasertib on the Pharmacokinetics of Oral Rosuvastatin in Healthy Participants Capivasertib, Rosuvastatin - Healthy Participants | Phase 1 | Completed | AstraZeneca | 20 | 2025-07-28 | 2026-03-03 |
| Capivasertib+Fulvestrant asTreatment for Locally Advanced(Inoperable) or Metastatic HR+/HER2- Breast Cancer in Chinese Patients Capivasertib, Fulvestrant - Breast Cancer | Phase 3 | Active not recruiting | AstraZeneca | 293 | 2024-09-26 | 2026-08-17 |
| Immunotherapy, Hormone Therapy, and AKT Inhibitor for Premenopausal ER Positive MBC Goserelin, Fulvestrant, Capivasertib - Premenopausal Breast Cancer, Metastatic Breast Cancer | Phase 2 | Recruiting | National Taiwan University Hospital | 42 | 2023-01-17 | 2024-06-10 |
| IACS-6274 With or Without Bevacizumab and Paclitaxel for the Treatment of Advanced Solid Tumors Bevacizumab, Glutaminase-1 Inhibitor IACS-6274, Paclitaxel - Advanced Endometrial Carcinoma, Advanced Head and Neck Squamous Cell Carcinoma | Phase 1 | Recruiting | M.D. Anderson Cancer Center | 54 | 2021-09-30 | 2026-10-06 |
| Capivasertib China PK Study Capivasertib, Paclitaxel - Advanced Solid Tumours | Phase 1 | Completed | AstraZeneca | 16 | 2021-02-22 | 2022-08-19 |
| A Phase 1b Study of T-DXd Combinations in HER2-low Advanced or Metastatic Breast Cancer Trastuzumab deruxtecan, Durvalumab, Paclitaxel - Metastatic Breast Cancer | Phase 1 | Active not recruiting | AstraZeneca | 138 | 2020-12-17 | 2026-08-03 |
| A Multi-centre Study to Assess the Safety, Tolerability, and Pharmacokinetics of Capivasertib (AZD5363) in Combination With Novel Agents in Patients With Metastatic Prostate Cancer Capivasertib, Enzalutamide, Abiraterone - Prostate Cancer | Phase 1 | Completed | AstraZeneca | 27 | 2019-08-05 | 2022-07-13 |
| Capivasertib+Paclitaxel as First Line Treatment for Patients With Locally Advanced or Metastatic TNBC Capivasertib, Paclitaxel, Placebo - Triple Negative Breast Neoplasms | Phase 3 | Active not recruiting | AstraZeneca | 923 | 2019-06-25 | 2025-12-22 |
| A Study of Novel Anti-cancer Agents in Patients With Metastatic Triple Negative Breast Cancer Durvalumab, Capivasertib, Oleclumab - Triple Negative Breast Neoplasms | Phase 1 / Phase 2 | Active not recruiting | AstraZeneca | 243 | 2018-12-21 | 2026-08-04 |
| AMTEC IIT: Phase 2 Multiarm Study in TNBC Biopsy, Capivasertib, Ceralasertib - Anatomic Stage IV Breast Cancer AJCC v8, Metastatic Triple-Negative Breast Carcinoma | Phase 2 | Terminated | Gordon Mills, MD, PhD | 24 | 2018-12-12 | 2026-02-25 |
| Testing the Combination of Olaparib and Durvalumab, Cediranib and Durvalumab, Olaparib and Capivasertib, and Cediranib Alone in Recurrent or Refractory Endometrial Cancer Following the Earlier Phase of the Study That Tested Olaparib and Cediranib in Comparison to Cediranib Alone, and Olaparib Alone Biospecimen Collection, Bone Marrow Aspirate, Bone Marrow Biopsy - Endometrial Adenocarcinoma, Endometrial Mixed Cell Adenocarcinoma | Phase 2 | Active not recruiting | National Cancer Institute (NCI) | 288 | 2018-09-27 | 2026-10-22 |
| AZD5363 in Patients With Advanced Solid Tumors Harboring AKT Mutations AZD5363, Enzalutamide, Fulvestrant - Breast Cancer, Prostate Cancer | Phase 1 | Completed | Memorial Sloan Kettering Cancer Center | 12 | 2017-10-11 | 2023-05-06 |
| The UK Plasma Based Molecular Profiling of Advanced Breast Cancer to Inform Therapeutic CHoices (plasmaMATCH) Trial Fulvestrant, Neratinib, AZD5363 - Advanced Breast Cancer | Phase 2 | Unknown | Institute of Cancer Research, United Kingdom | 1150 | 2016-12-15 | 2019-01-22 |
| European Proof-of-Concept Therapeutic Stratification Trial of Molecular Anomalies in Relapsed or Refractory Tumors Ribociclib, Topotecan, Temozolomide - Pediatric Cancer | Phase 1 / Phase 2 | Recruiting | Gustave Roussy, Cancer Campus, Grand Paris | 472 | 2016-08-03 | 2026-07-10 |
| Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y) Capivasertib - Advanced Lymphoma, Advanced Malignant Solid Neoplasm | Phase 2 | Active not recruiting | National Cancer Institute (NCI) | 35 | 2016-05-31 | 2026-05-06 |
| OLAParib COmbinations AZD2281, AZD5363, AZD1775 - Cancer | Phase 2 | Terminated | Joseph Paul Eder | 67 | 2015-11-01 | 2022-12-28 |
| Vismodegib, FAK Inhibitor GSK2256098, Capivasertib, and Abemaciclib in Treating Patients With Progressive Meningiomas Vismodegib, FAK Inhibitor GSK2256098, Capivasertib - Intracranial Meningioma, Recurrent Meningioma | Phase 2 | Recruiting | Alliance for Clinical Trials in Oncology | 124 | 2015-09-28 | 2026-10-19 |
| Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) Adavosertib, Afatinib, Afatinib Dimaleate - Advanced Lymphoma, Advanced Malignant Solid Neoplasm | Phase 2 | Active not recruiting | National Cancer Institute (NCI) | 6452 | 2015-08-17 | 2026-10-22 |
| National Lung Matrix Trial: Multi-drug Phase II Trial in Non-Small Cell Lung Cancer AZD4547, Vistusertib, Palbociclib - Non-Small Cell Lung Cancer, Carcinoma, Squamous Cell | Phase 2 | Completed | University of Birmingham | 423 | 2015-05-13 | 2026-04-28 |
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Breast Neoplasms (12) · Triple Negative Breast Neoplasms (6) · Ovarian Neoplasms (4) · Prostatic Neoplasms (4) · Endometrial Neoplasms (3) · Hematologic Neoplasms (2) · Lung Neoplasms (2) · Lymphoma (2) · Melanoma (2) · Multiple Myeloma (2) · Neoplasm Metastasis (2) · Neoplasms (2) · Uterine Cervical Neoplasms (2) · Adenocarcinoma (1) · Carcinoma, Endometrioid (1)
AstraZeneca (11) · National Cancer Institute (NCI) (3) · Institute of Cancer Research, United Kingdom (2) · M.D. Anderson Cancer Center (2) · Samsung Medical Center (2) · UNICANCER (2) · Alliance for Clinical Trials in Oncology (1) · Gordon Mills, MD, PhD (1) · Gustave Roussy, Cancer Campus, Grand Paris (1) · Joseph Paul Eder (1) · Memorial Sloan Kettering Cancer Center (1) · National Taiwan University Hospital (1) · Queen Mary University of London (1) · Royal Marsden NHS Foundation Trust (1) · University Hospital Southampton NHS Foundation Trust (1)
United States (16) · United Kingdom (13) · France (7) · South Korea (6) · Canada (5) · Spain (4) · Taiwan (4) · China (3) · Japan (3) · Netherlands (3) · Brazil (2) · Denmark (2) · Hungary (2) · Italy (2) · Mexico (2)
Udai Banerji, MD, PhD (2) · Alison Schram, MD (1) · Birgit Geoerger, MD (1) · Gaia Schiavon, MSD (1) · Gary W Middleton (1) · Gordon Mills, MD, PhD (1) · Helen J Mackay (1) · Jian Zhang (1) · Johann De Bono, Professor (1) · John FR Robertson, MD (1) · Joseph P Eder, MD (1) · Justin Lindemann, MSD (1)
PMID 32379297, PMID 26351323, PMID 26410619, PMID 26586415, PMID 28144789, PMID 29066505, PMID 31538815, PMID 31841354, PMID 32035020, PMID 32067679, PMID 32205016, PMID 32312891, PMID 32463741, PMID 32532747, PMID 32669708, PMID 32919527, PMID 33048619, PMID 33326257, PMID 33863913, PMID 33892407, PMID 33893289, PMID 34250397, PMID 34347542, PMID 34543871, PMID 35133871, PMID 35138919, PMID 35292802, PMID 35440569, PMID 35671774, PMID 36288512, PMID 36351402, PMID 36572571, PMID 37053535, PMID 37322121, PMID 37934000, PMID 38127487, PMID 38591867, PMID 39666929, PMID 39693587, PMID 39913886, PMID 40069402, PMID 40153687, PMID 40525978, PMID 40865033, PMID 41066729, PMID 41088025, PMID 41545592, PMID 41838385, PMID 42259988, PMID 42686334
2018 (2), U10CA180820 (2), U24CA196172 (2), 2014 (1), 2016 (1), 2023 (1), P50CA083639 (1), U10CA180868 (1)