Clinical Trials

Phase 1/2 Active not recruiting

2,900 enrolled

Gynecologic

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

NCT05230810 2026-03-16

Clinical Trial of Alpelisb and Tucatinib in Patients With PIK3CA-Mutant HER2+ Metastatic Breast Cancer.

40 enrolled

HER2-positive Metastatic Breast Cancer

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

NCT05154487 2026-03-03

A Study of Alpelisib and Fulvestrant to Treat Endometrial Cancer

51 enrolled

Recurrence

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

NCT04251533 2026-02-13

EPIK-B3

137 enrolled 21 charts

Triple Negative Breast Neoplasms

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

Phase 2 Completed

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

NCT03138070 2026-01-28

A Window of Opportunity Study to Assess the Modulation of Biomarkers in Head and Neck Squamous Cell Cancer (HNSCC) By Preoperative Treatment With BYL719

Phase NA Completed

15 enrolled

Head & Neck

Head and Neck Squamous Cell Cancer

NCT05933395 2026-01-20

GERTRUDE

135 enrolled

Tumor-Agnostic

Neoplasm Metastasis

NCT03056755 2026-01-13

BYLieve

Phase 2 Completed

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

NCT05563220 2026-01-06

ELEVATE

Phase 1/2 Recruiting

435 enrolled

Breast Neoplasms

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

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

Head & Neck

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

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

Breast Neoplasms

NCT05090358 2025-10-27

Preventing High Blood Sugar in People Being Treated for Metastatic Breast Cancer

15 enrolled

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

NCT05063786 2025-09-08

ALPHABET

27 enrolled

Breast Neoplasms

NCT05625087 2025-08-20

SAFIR 03

162 enrolled

Breast Neoplasms

NCT04300790 2025-07-29

METALLICA

Phase 2 Completed

69 enrolled

BreastEndocrine

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

NCT04544189 2025-06-18

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

69 enrolled

Phase 1 Active not recruiting

Breast Neoplasms

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

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

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

NCT05966584 2024-08-29

A Study to Prevent Rash in People Starting Alpelisib for the Treatment of Breast Cancer

1 enrolled 5 charts

Breast Neoplasms, Exanthema

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

Head & Neck

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

NCT01300962 2023-12-04

Study of BKM120 or BYL719 and Capecitabine in Patients With Metastatic Breast Cancer

47 enrolled

BreastGastrointestinalThoracic

Breast Neoplasms, Neoplasm Metastasis

NCT04753203 2023-10-31

ALCAP

Phase 1/2 Unknown

65 enrolled

Gastrointestinal

Colorectal Neoplasms

NCT04591431 2023-10-03

ROME

Phase 2 Unknown

400 enrolled

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

NCT02273219 2023-08-15

Trial of AEB071 in Combination With BYL719 in Patients With Melanoma