Clinical Trials

2,900 enrolled

Gynecologic

Fallopian Tube Neoplasms, Neoplasm Metastasis, Ovarian Neoplasms, Endometrial Neoplasms

NCT04729387 2026-03-13

Alpelisib Plus Olaparib in Platinum-resistant/Refractory, High-grade Serous Ovarian Cancer, With no Germline BRCA Mutation Detected

Phase 3 Terminated

358 enrolled

Gynecologic

Ovarian Neoplasms

NCT05022342 2026-02-23

SPEAR

Completed

595 enrolled

Breast Neoplasms

NCT05038735 2026-02-20

EPIK-B5

212 enrolled

Breast Neoplasms

NCT05983159 2026-02-19

TARGET-VM

50 enrolled

Arteriovenous Malformations, Lymphangioma, Skin Diseases, Vascular, Lymphangioma, Cystic, Lymphatic Abnormalities, Vascular Malformations

NCT05948943 2026-02-13

EPIK-L1

Phase 2/3 Recruiting

232 enrolled

Lymphangioma, Lymphangioma, Cystic, Lymphatic Abnormalities

NCT05101564 2026-02-12

Umbrella Trial of Subtype-Targeted Therapies in ER+/HER2- Breast Cancer

19 enrolled 10 charts

Breast Neoplasms

NCT05501886 2026-02-10

VIKTORIA-1

701 enrolled

Breast Neoplasms, Neoplasm Metastasis

NCT05646862 2026-02-05

INAVO121

420 enrolled

Breast Neoplasms

NCT04208178 2026-02-02

EPIK-B2

19 enrolled

Phase 1/2 Active not recruiting

Advanced HER2+Breast Cancer

NCT01872260 2026-01-30

Study of LEE011, BYL719 and Letrozole in Advanced ER+ Breast Cancer

255 enrolled

Breast Neoplasms

NCT05933395 2026-01-20

GERTRUDE

135 enrolled

Tumor-Agnostic

Neoplasm Metastasis

NCT03056755 2026-01-13

BYLieve

383 enrolled 16 charts

Breast Neoplasms, Hereditary Sensory and Autonomic Neuropathies

NCT05826964 2026-01-13

Levels of Circulating Tumor DNA as a Predictive Marker for Early Switch in Treatment for Patients With Metastatic (Stage IV) Breast Cancer

24 enrolled

Breast Neoplasms

NCT04524000 2026-01-12

Study Assessing the Efficacy and Safety of Treatment With Alpelisib Plus Fulvestrant in Japanese Men and Postmenopausal Women With Advanced Breast Cancer

24 enrolled

Advanced Breast Cancer

NCT04762979 2026-01-02

Alpelisib (BYL719) in Combination With Continued Endocrine Therapy Following Progression on Endocrine Therapy in Hormone Receptor Positive, HER2 Negative, PIK3CA Mutant Metastatic Breast Cancer

44 enrolled

Hormone Receptor Positive Breast Carcinoma

NCT06083038 2025-12-31

Utilizing Continuous Glucose Monitoring to Characterize and Manage Hyperglycemia in Patients Initiating Alpelisib

Active not recruiting

15 enrolled

Breast Neoplasms, Hyperglycemia

NCT04997902 2025-12-23

Combination Trial of Tipifarnib and Alpelisib in Adult Recurrent/ Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC)

Phase 1/2 Completed

45 enrolled

Squamous Cell Carcinoma of Head and Neck, Head and Neck Neoplasms, Hereditary Sensory and Autonomic Neuropathies, Recurrence

NCT04967248 2025-12-04

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

Terminated

4 enrolled

Breast Neoplasms

NCT05631795 2025-12-03

ALPINIST

Phase 4 Completed

40 enrolled

Endocrine

Multiple Endocrine Neoplasia Type 1

NCT03284957 2025-11-24

AMEERA-1

Phase 1/2 Terminated

136 enrolled 60 charts

Phase 1 Active not recruiting

Breast Neoplasms

NCT05143229 2025-10-06

ASSET

18 enrolled

Breast Neoplasms, Neoplasm Metastasis

NCT04216472 2025-09-30

Nab-paclitaxel and Alpelisib for the Treatment of Anthracycline Refractory Triple Negative Breast Cancer With PIK3CA or PTEN Alterations

6 enrolled

Breast Neoplasms, Triple Negative Breast Neoplasms

NCT05392608 2025-09-17

SEQUEL-Breast

130 enrolled

Breast Neoplasms, Genetic Diseases, Inborn

NCT05625087 2025-08-20

SAFIR 03

162 enrolled

Breast Neoplasms

NCT04300790 2025-07-29

METALLICA

Phase 1 Active not recruiting

69 enrolled

BreastEndocrine

Breast Neoplasms, Hyperglycemia, Neoplasm Metastasis, Multiple Endocrine Neoplasia Type 1

NCT04188548 2025-06-04

EMBER

500 enrolled

BreastGynecologic

Breast Neoplasms, Endometrial Neoplasms

NCT02437318 2025-02-13

SOLAR-1

Phase 3 Completed

572 enrolled 22 charts 1 FDA

BreastEndocrine

Breast Neoplasms, Neoplasms, Multiple Endocrine Neoplasia Type 1

NCT06739395 2024-12-18

Precision Medicine Trial Based on Molecular Matching Therapy for Patients With Standard Treatment Exhaustion

300 enrolled

Other solid neoplasm

Solid Tumor

NCT01870505 2024-12-09

BYL719 Plus Letrozole or Exemestane for Patients With Hormone-Receptor Positive Locally-Advanced Unresectable or Metastatic Breast Cancer

Phase 1 Completed

52 enrolled 19 charts

Tumor-Agnostic

Neoplasm Metastasis

NCT03207529 2024-10-10

Alpelisib and Enzalutamide in Treating Patients With Androgen Receptor and PTEN Positive Metastatic Breast Cancer

Phase 1 Completed

18 enrolled

Breast Neoplasms, Triple Negative Breast Neoplasms

NCT04899349 2024-10-09

EPIK-B4

2 enrolled 8 charts

Breast Neoplasms, Hyperglycemia, Hereditary Sensory and Autonomic Neuropathies

NCT03631953 2024-08-06

ALTREM

Phase 1 Recruiting

25 enrolled

CNS

Meningioma

NCT03439046 2024-08-01

BioItaLEE

Phase 3 Completed

287 enrolled

Phase 1 Active not recruiting

Breast Neoplasms, Hereditary Sensory and Autonomic Neuropathies

NCT01791478 2024-07-23

BYL719 and Letrozole in Post-Menopausal Patients With Hormone Receptor-Positive Metastatic Breast Cancer

46 enrolled

Breast Neoplasms, Carcinoma, Ductal, Breast

NCT04862143 2024-06-20

TELEPIK

2 enrolled 10 charts

Advanced Breast Cancer

NCT03601507 2024-04-17

Alpelisib in Treating Participants With Transorally Resectable HPV-Associated Stage I-IVA Oropharyngeal Cancer

9 enrolled 10 charts

Squamous Cell Carcinoma of Head and Neck

NCT05967286 2024-03-20

Olaparib and Alpelisib for Treatment of Metastatic Breast Cancer, A ComboMATCH Treatment Trial

Phase 2 Withdrawn

Phase EARLY_PHASE1 Withdrawn

Anatomic Stage III Breast Cancer AJCC v8

NCT05238831 2024-01-23

SMMART Adaptive Clinical Treatment (ACT) Trial

BreastGastrointestinalGenitourinaryGynecologicSarcoma

Breast Neoplasms, Ovarian Neoplasms, Pancreatic Neoplasms, Prostatic Neoplasms, Sarcoma

NCT03941782 2024-01-11

Compassionate Use of BYL 719 Alpelisib

No longer available

Lymphangioma

NCT04753203 2023-10-31

ALCAP

Phase 1/2 Unknown

65 enrolled

Gastrointestinal

Colorectal Neoplasms

NCT04591431 2023-10-03

ROME

Phase 2 Unknown

400 enrolled

BreastGastrointestinalThoracic

Breast Neoplasms, Carcinoma, Non-Small-Cell Lung, Gastrointestinal Neoplasms

NCT04801966 2023-05-10

TAILOR

Phase NA Terminated

3 enrolled

Tumor-Agnostic

Neoplasms

NCT04285723 2023-02-09

EPIK-P1

Completed

57 enrolled 23 charts 1 FDA

Hereditary Sensory and Autonomic Neuropathies

NCT03386162 2022-11-28

SAFIR-PI3K

31 enrolled

Breast Neoplasms, Hereditary Sensory and Autonomic Neuropathies

NCT02506556 2022-08-16

PIKNIC

38 enrolled

Breast Neoplasms

NCT02734615 2022-08-01

Phase I/Ib Trial of LSZ102 Single Agent or LSZ102 + LEE011 or LSZ102 + BYL719 in ER+ Breast Cancers

Phase 1 Terminated

199 enrolled

Advanced or Metastatic ER+ Breast Cancer

NCT02379247 2022-06-07

BYL719 and Nab-Paclitaxel in Locally Recurrent or Metastatic HER-2 Negative Breast Cancer

Phase 1/2 Completed

43 enrolled 18 charts

Breast Neoplasms

NCT03292250 2022-03-29

Korean Cancer Study Group: Translational bIomarker Driven UMbrella Project for Head and Neck (TRIUMPH), Esophageal Squamous Cell Carcinoma- Part 1 (HNSCC)]

180 enrolled

Squamous Cell Carcinoma of Head and Neck, Head and Neck Neoplasms

NCT02282371 2021-10-26

Cetuximab + BYL719 + IMRT (Intensity-Modulated Radiation Therapy) in Stage III/IVB Head and Neck Squamous Cell Cancer (HNSCC)

Phase 1 Completed

16 enrolled