20 completed, 18 active not recruiting, 14 recruiting, 4 not yet recruiting. 33 Phase 2, 28 Phase 1, 11 Phase 3.
Follow capivasertib: new trials by email Literature Review of capivasertib trials Research Report on capivasertib
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 |
|---|---|---|---|---|---|---|
| Immunotherapy Plus Capivasertib for Metastatic Bladder Cancer capivasertib - Advanced Urothelial Carcinoma | Phase 1 / Phase 2 | Not yet recruiting | VA Office of Research and Development | 32 | 2027-01-01 | 2026-10-05 |
| Adding Capivasertib to Standard Treatment in HR Positive, HER2 Negative Metastatic Breast Cancer Based on ctDNA Testing NSAI + CDK4/6i, NSAI + CDK4/6i + Capivasertib, Fulvestrant + CDK4/6i + Capivasertib - HR Positive/HER-2 Negative Breast Cancer | Phase 3 | Not yet recruiting | SWOG Cancer Research Network | 1084 | 2026-10-30 | 2026-09-03 |
| HEM-iSMART E: Capivasertib + Venetoclax + Dexamethasone in Pediatric Patients With Relapsed or Refractory Hematological Malignancies Capivasertib, Venetoclax, Dexamethasone - Acute Lymphoblastic Leukemia, Lymphoblastic Lymphoma (Precursor B-Lymphoblastic Lymphoma/Leukaemia) Recurrent | Phase 1 / Phase 2 | Not yet recruiting | Princess Maxima Center for Pediatric Oncology | 42 | 2026-10-01 | 2025-09-16 |
| Rash & Diarrhea Prophylaxis With Capivasertib Capivasertib, Loperamide, Fulvestrant - Metastatic HR+/HER2- Breast Cancer | Phase 2 | Recruiting | Maryam Lustberg | 108 | 2026-08-15 | 2026-07-29 |
| Osimertinib Plus Capivasertib in NSCLC With PIK3CA/AKT1/PTEN Alterations Following Prior 1L Osimertinib Capivasertib in combination with Osimertinib - Lung Cancer (NSCLC), Lung Cancer (Non-Small Cell) | Phase 1 / Phase 2 | Not yet recruiting | Shanxi Province Cancer Hospital | 53 | 2026-05-15 | 2026-03-24 |
| A Study to Investigate the Effect of Capivasertib on the Pharmacokinetics of Oral Dextromethorphan (CYP2D6 Substrate) in Healthy Participants Dextromethorphan, Capivasertib - Healthy Participants | Phase 1 | Completed | AstraZeneca | 42 | 2026-03-19 | 2026-07-27 |
| CApivasertib, Venetoclax And Low-intensity chemotheRapY for Adults With ALL/LBL Capivasertib, Venetoclax, Rituximab - Leukemia, Lymphoma | Phase 1 / Phase 2 | Recruiting | University of Chicago | 104 | 2026-03-17 | 2026-03-04 |
| Study of AMXT 1501 and DFMO in Combination With Standard Therapies in Advanced Solid Tumors AMXT 1501 Dicaprate, DFMO, Fulvestrant - Melanoma (Skin Cancer), HER2-low Hormone Receptor Positive Breast Cancer | Phase 1 / Phase 2 | Recruiting | Aminex Therapeutics, Inc. | 92 | 2026-01-26 | 2026-10-22 |
| 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 |
| Phase III Study to Evaluate the Safety, Efficacy, and Impact on Quality of Life of Capivasertib Alongside Standard-of-care Endocrine Treatment in Patients With HR+/HER2- Advanced Breast Cancer and Progression on Prior Endocrine-based Treatment Capivasertib - Breast Cancer, HR-positive Breast Cancer | Phase 3 | Recruiting | Women's Cancer Study Group GmbH | 250 | 2025-11-27 | 2026-08-05 |
| Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer Zovegalisib, Capivasertib, Fulvestrant - PIK3CA Mutation, HER2- Negative Breast Cancer | Phase 3 | Recruiting | Relay Therapeutics, Inc. | 540 | 2025-08-26 | 2026-10-05 |
| 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 |
| Effect of Capivasertib on ctDNA in ER Positive Breast Cancer Capivasertib - Breast Cancer, Oestrogen Receptor Positive Breast Cancer | Phase 2 | Withdrawn | Imperial College London | 2025-02-01 | 2025-12-24 | |
| A Phase IIIB Study to Evaluate the Use of Capivasertib in Combination With Fulvestrant in Patients With Advanced Breast Cancer Who Have Relapsed/Progressed on ET and CDK4/6 Inhibitor Reflecting Real World Clinical Practice in Spain Fulvestrant, Capivasertib - Locally Advanced or Metastatic Breast Cancer | Phase 3 | Active not recruiting | AstraZeneca | 101 | 2025-01-07 | 2026-10-15 |
| Capivasertib Plus Fulvestrant vs. Fulvestrant in Primary High-risk Lobular Breast Cancer Capivasertib, Fulvestrant injection - CCCA Assessed by Ki67 Drop Below <2.7% From Baseline | Phase 2 | Recruiting | GBG Forschungs GmbH | 120 | 2024-12-04 | 2025-04-02 |
| 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 |
| A Single-Arm Phase II Study of Neoadjuvant Intensified Androgen Deprivation (Leuprolide and Abiraterone Acetate) in Combination With AKT Inhibition (Capivasertib) for High-Risk Localized Prostate Cancer With PTEN Loss Capivasertib, abiraterone acetate - High-Risk Prostate Cancer | Phase 2 | Recruiting | VA Office of Research and Development | 30 | 2024-05-31 | 2026-10-05 |
| Levels of Circulating Tumor DNA as a Predictive Marker for Early Switch in Treatment for Patients With Metastatic (Stage IV) Breast Cancer AI+CDK4/6i, SERD+CDK4/6i, mTOR inhibitor + AI - Breast Cancer, ER-positive Breast Cancer | Phase 2 | Active not recruiting | University of Miami | 24 | 2023-06-12 | 2026-01-13 |
| Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Participants With Metastatic Breast Cancer Elacestrant, Alpelisib, Everolimus - Breast Cancer, Metastatic Breast Cancer | Phase 1 / Phase 2 | Active not recruiting | Stemline Therapeutics, Inc. | 435 | 2023-01-24 | 2026-06-12 |
| 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 |
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Breast Neoplasms (21) · Prostatic Neoplasms (8) · Triple Negative Breast Neoplasms (6) · Neoplasm Metastasis (5) · Ovarian Neoplasms (4) · Endometrial Neoplasms (3) · Hematologic Neoplasms (3) · Lung Neoplasms (3) · Lymphoma (3) · Melanoma (3) · Carcinoma, Non-Small-Cell Lung (2) · Disease Progression (2) · Leukemia (2) · Multiple Myeloma (2) · Neoplasms (2)
AstraZeneca (23) · National Cancer Institute (NCI) (3) · Institute of Cancer Research, United Kingdom (2) · M.D. Anderson Cancer Center (2) · Samsung Medical Center (2) · UNICANCER (2) · VA Office of Research and Development (2) · Alliance for Clinical Trials in Oncology (1) · Aminex Therapeutics, Inc. (1) · GBG Forschungs GmbH (1) · Gordon Mills, MD, PhD (1) · Gustave Roussy, Cancer Campus, Grand Paris (1) · Imperial College London (1) · Joseph Paul Eder (1) · Karolinska Institutet (1)
United States (32) · United Kingdom (23) · France (14) · South Korea (13) · Spain (13) · Canada (12) · Belgium (9) · Germany (9) · Taiwan (9) · China (8) · Australia (7) · Brazil (7) · Japan (7) · Poland (7) · Argentina (6)
Udai Banerji, MD, PhD (2) · Alison Schram, MD (1) · Andrej Lissat, MD PhD (1) · Ashkan Mortezavi, MD, PhD (1) · Birgit Geoerger, MD (1) · Caner Saygin (1) · Chong-Xian Pan, MD PhD (1) · Deyaa Adib, MD (1) · Dr Farah Rehman (1) · Frances Valdes-Albini, MD (1) · Gaia Schiavon, MSD (1) · Gary W Middleton (1) · Gordon Mills, MD, PhD (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 32586393, 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 35317973, PMID 35440569, PMID 35671774, PMID 36288512, PMID 36351402, PMID 36572571, PMID 37053535, PMID 37322121, PMID 37934000, PMID 38127487, PMID 38591867, PMID 38643311, PMID 39159418, PMID 39164518, PMID 39214106, PMID 39283299, PMID 39666929, PMID 39693587, PMID 39913886, PMID 40069402, PMID 40153687, PMID 40263079
2023 (6), 2018 (3), U10CA180820 (2), U24CA196172 (2), 2014 (1), 2016 (1), 2019 (1), 2025 (1), I01CX002517 (1), P50CA083639 (1), U10CA180868 (1)