42 completed, 19 terminated, 18 active not recruiting, 14 recruiting. 48 Phase 2, 47 Phase 1, 10 Phase 3, 2 Not applicable, 1 Early Phase 1.
Follow Alpelisib: new trials by email Literature Review of Alpelisib trials Research Report on Alpelisib
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 |
|---|---|---|---|---|---|---|
| Roll-Over Study of Alpelisib (BYL719) for Continued Access and Long-Term Safety. Alpelisib, Fulvestrant, Trastuzumab - PIK3CA-Related Overgrowth Spectrum (PROS), Breast Neoplasms (Including Advanced or Metastatic Breast Cancer With PIK3CA Mutation) | Phase 2 | Not yet recruiting | Novartis Pharmaceuticals | 51 | 2026-12-15 | 2026-09-18 |
| Alpelisib Challenge Test (ACT) Alpelisib 300 mg, Alpelisib Challenge Test (ACT): Mixed Meal Tolerance Test (MMTT) after taking alpelisib, Hyperglycemic clamp - Insulin Resistance, Type 2 Diabetes | Phase 1 | Recruiting | Columbia University | 15 | 2026-09-02 | 2026-09-03 |
| EPIK-P4: A Phase II Single-arm Study to Assess the Efficacy, Safety and Pharmacokinetics of Alpelisib (BYL719) in Pediatric and Adult Patients With PIK3CA-related Overgrowth Spectrum (PROS) Alpelisib - PIK3CA-related Overgrowth Spectrum (PROS) | Phase 2 | Recruiting | Novartis Pharmaceuticals | 140 | 2025-10-09 | 2026-10-09 |
| 24VA022; VATCH Alpelisib for TIE2/PIK3CA Pathway VAs alpelisib (BYL719) - Vascular Anomalies, Vascular Anomaly | Phase 2 | Recruiting | Children's Hospital of Philadelphia | 61 | 2025-08-27 | 2026-10-19 |
| Precision Medicine Trial Based on Molecular Matching Therapy for Patients With Standard Treatment Exhaustion Olaparib tablet, Temozolomide capsule, Anlotinib - Solid Tumor, Precision Medicine | Phase 2 | Recruiting | Tianjin Medical University Second Hospital | 300 | 2024-11-01 | 2024-12-18 |
| Phase Ib Study of AlpeliSib With PEmbroLizumab in Patients With mEtastatic Breast caNcer or melanomA (SELENA) Alpelisib + Pembrolizumab - Melanoma (Skin Cancer), Breast Cancer | Phase 1 | Recruiting | M.D. Anderson Cancer Center | 50 | 2024-10-15 | 2026-10-06 |
| Genetically-informed Therapy for ER+ Breast Cancer Post-CDK4/6 Inhibitor Fulvestrant, Neratinib, Alpelisib - Advanced Breast Cancer | Phase 2 | Recruiting | Dartmouth-Hitchcock Medical Center | 135 | 2024-09-23 | 2026-01-20 |
| A Trial of Targeted Therapies for Patients With Slow-Flow or Fast-Flow Vascular Malformations Alpelisib, Mirdametinib - Slow-Flow Vascular Malformation, Fast-Flow Vascular Malformation | Phase 2 | Recruiting | Murdoch Childrens Research Institute | 50 | 2024-09-13 | 2026-05-05 |
| A Study of Alpelisib and Fulvestrant to Treat Endometrial Cancer Alpelisib Pill, Fulvestrant injection - Endometroid Endometrial Cancer | Phase 2 | Active not recruiting | GOG Foundation | 51 | 2024-09-11 | 2026-07-30 |
| Human Models of Selective Insulin Resistance: Alpelisib, Part I Alpelisib 300 mg, Placebo, [1-13C] sodium acetate - Insulin Resistance, Prediabetic State | Phase 1 | Recruiting | Columbia University | 32 | 2024-04-24 | 2026-08-24 |
| Alpelisib in Pediatric and Adult Patients With Lymphatic Malformations Associated With a PIK3CA Mutation. Alpelisib, Placebo - Lymphatic Malformations | Phase 2 / Phase 3 | Recruiting | Novartis Pharmaceuticals | 232 | 2023-11-24 | 2026-10-09 |
| Olaparib and Alpelisib for Treatment of Metastatic Breast Cancer, A ComboMATCH Treatment Trial Alpelisib, Biopsy, Biospecimen Collection - Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IV Breast Cancer AJCC v8 | Phase 2 | Withdrawn | National Cancer Institute (NCI) | 2023-10-23 | 2024-03-20 | |
| Detection of Tumor DNA in the Blood of Patients Receiving Standard Therapy for Hormone Receptor-positive (HR+) Non-HER2 Expressing (HER2-) Metastatic Breast Cancer as a Tool to Select Those Who May Benefit From the Next Course of Fulvestrant in Combination With Alpelisib or Ribociclib Alpelisib, Ribociclib - Breast Cancer Stage IV | Phase 2 | Terminated | UNICANCER | 4 | 2023-10-19 | 2026-10-14 |
| Utilizing Continuous Glucose Monitoring to Characterize and Manage Hyperglycemia in Patients Initiating Alpelisib Alpelisib, FreeStyle Libre 2 Continuous Glucose Monitor - Metastatic Breast Cancer | Completed | HealthPartners Institute | 8 | 2023-10-05 | 2026-05-06 | |
| A Study to Prevent Rash in People Starting Alpelisib for the Treatment of Breast Cancer Benralizumab, fulvestrant or AIs) and PI3K inhibition (alpelisib) - Breast Cancer | Phase 2 | Terminated | Memorial Sloan Kettering Cancer Center | 1 | 2023-07-06 | 2024-08-29 |
| A NIS of Alpelisib in Combination With Fulvestrant in Postmenopausal Women, and Men, With HR+,HER2- , Locally Advanced or Metastatic Breast Cancer With a PIK3CA Mutation, After Disease Progression Following Endocrine Therapy as Monotherapy, in the Real-world Setting Alpelisib, Fulvestrant - Hormone Receptor Positive HER2 Negative Breast Cancer With a PIK3CA Mutation | Terminated | Novartis Pharmaceuticals | 4 | 2023-06-21 | 2025-12-04 | |
| 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 |
| A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy Inavolisib, Fulvestrant, Alpelisib - Breast Cancer | Phase 3 | Recruiting | Hoffmann-La Roche | 420 | 2023-06-07 | 2026-09-28 |
| Effect of Alpelisib in Healthy Volunteers Alpelisib 150 mg [Piqray], 2 overencapsulated tablets (total: 300 mg), Placebo (microcrystalline cellulose), 2 capsules, FreeStyle Libre Pro - Insulin Resistance, Hyperinsulinemia | Phase 1 | Completed | Columbia University | 23 | 2023-05-09 | 2023-12-21 |
| Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial Alpelisib, Binimetinib, Biopsy Procedure - Advanced Malignant Solid Neoplasm, Anatomic Stage III Breast Cancer AJCC v8 | Phase 2 | Recruiting | National Cancer Institute (NCI) | 2900 | 2023-04-07 | 2026-10-15 |
Showing 20 of 107. Sign in to see all of them.
Breast Neoplasms (49) · Neoplasm Metastasis (11) · Hereditary Sensory and Autonomic Neuropathies (9) · Recurrence (6) · Neoplasms (5) · Ovarian Neoplasms (5) · Squamous Cell Carcinoma of Head and Neck (5) · Head and Neck Neoplasms (3) · Hyperglycemia (3) · Hyperinsulinism (3) · Insulin Resistance (3) · Lymphangioma (3) · Multiple Endocrine Neoplasia Type 1 (3) · Triple Negative Breast Neoplasms (3) · Colorectal Neoplasms (2)
Novartis Pharmaceuticals (42) · Memorial Sloan Kettering Cancer Center (5) · Columbia University (4) · M.D. Anderson Cancer Center (3) · National Cancer Institute (NCI) (2) · Pamela Munster (2) · Peter MacCallum Cancer Centre, Australia (2) · UNICANCER (2) · Array BioPharma (1) · Assistance Publique Hopitaux De Marseille (1) · Blokhin's Russian Cancer Research Center (1) · Borstkanker Onderzoek Groep (1) · Celcuity Inc (1) · Centre Hospitalier Universitaire Dijon (1) · Children's Hospital of Philadelphia (1)
United States (68) · France (31) · Spain (30) · Italy (27) · Australia (21) · South Korea (21) · Belgium (19) · Germany (19) · United Kingdom (18) · Canada (16) · Netherlands (16) · Taiwan (12) · Japan (9) · Singapore (9) · Switzerland (9)
Joshua R Cook, MD, PhD (3) · Pamela Munster, MD (2) · Priyanka Sharma, MD (2) · Aaron Hansen, M.D. (1) · Alina Markova, MD (1) · Andrea Botticelli (1) · Anthony Nichols (1) · Antonio Llombart (1) · Array BioPharma (1) · Claire Dees (1) · David Pfister, MD (1)
PMID 38439079, PMID 38112724, PMID 39177931, PMID 25002028, PMID 29401002, PMID 30167089, PMID 30468243, PMID 30543347, PMID 30723140, PMID 30880072, PMID 31091374, PMID 31322702, PMID 32164626, PMID 32416251, PMID 32718997, PMID 32864625, PMID 32887722, PMID 33246021, PMID 33602685, PMID 33780274, PMID 33794206, PMID 34012367, PMID 34433648, PMID 35086719, PMID 35110417, PMID 35149538, PMID 35272946, PMID 35465733, PMID 35524239, PMID 35598186, PMID 35787784, PMID 35840573, PMID 36066851, PMID 36800111, PMID 36870947, PMID 37424386, PMID 37624421, PMID 37634128, PMID 37699162, PMID 37875771, PMID 38630551, PMID 39241211, PMID 39637900, PMID 39806603, PMID 40603171, PMID 40700681, PMID 41023484, PMID 41423595, PMID 41527715, PMID 41802242
2023 (6), 2019 (3), 2015 (2), 2017 (2), K23DK140614 (2), 2018 (1), K12DK133995 (1), P30CA023074 (1), P30CA060553 (1), U10CA180820 (1), U10CA180821 (1)