Clinical Trials

Breast Neoplasms, Hyperglycemia

NCT05631795 2026-04-07

ALPINIST

Phase 4 Completed

40 enrolled

Endocrine

Multiple Endocrine Neoplasia Type 1

NCT05022342 2026-02-23

SPEAR

Completed

595 enrolled

Breast Neoplasms

NCT05101564 2026-02-12

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

19 enrolled 10 charts

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 and Neck Squamous Cell Cancer

NCT03056755 2026-01-13

BYLieve

383 enrolled 16 charts

Breast Neoplasms, Hereditary Sensory and Autonomic Neuropathies

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

NCT04300790 2025-07-29

METALLICA

572 enrolled 22 charts 1 FDA

69 enrolled

BreastEndocrine

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

NCT02437318 2025-02-13

SOLAR-1

Phase 3 Completed

BreastEndocrine

Breast Neoplasms, Neoplasms, Multiple Endocrine Neoplasia Type 1

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

NCT03439046 2024-08-01

BioItaLEE

Phase 3 Completed

287 enrolled

Breast Neoplasms, Hereditary Sensory and Autonomic Neuropathies

NCT01300962 2023-12-04

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

47 enrolled

Breast Neoplasms, Neoplasm Metastasis

NCT02273219 2023-08-15

Trial of AEB071 in Combination With BYL719 in Patients With Melanoma

57 enrolled 23 charts 1 FDA

30 enrolled

Dermatologic

Uveal Melanoma, Melanoma

NCT04285723 2023-02-09

EPIK-P1

Completed

Hereditary Sensory and Autonomic Neuropathies

NCT02506556 2022-08-16

PIKNIC

38 enrolled

Breast Neoplasms

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)

16 enrolled

Head and Neck Squamous Cell Cancer

NCT02167854 2021-07-09

Open-Label Study Evaluating the Safety and Tolerability of LJM716, BYL719 and Trastuzumab in Patients With Metastatic HER2+ Breast Cancer

23 enrolled

Breast Neoplasms

NCT01719380 2021-06-23

Study of LGX818 and Cetuximab or LGX818, BYL719, and Cetuximab in BRAF Mutant Metastatic Colorectal Cancer

156 enrolled 41 charts

Colorectal Neoplasms

NCT02537223 2021-04-19

Phase I Study of BYL719 in Combination With Cisplatin and Radiotherapy in Patients With Squamous Cell Head and Neck Cancer

9 enrolled

Squamous Cell Carcinoma of Head and Neck

NCT02155088 2021-04-08

BYL719 in Combination With Gemcitabine and (Nab)-Paclitaxel in Locally Advanced and Metastatic Pancreatic Cancer

15 enrolled

Neoplasm Metastasis, Pancreatic Neoplasms, Recurrence

NCT01623349 2021-02-10

Phase I Study of the Oral PI3kinase Inhibitor BKM120 or BYL719 and the Oral PARP Inhibitor Olaparib in Patients With Recurrent Triple Negative Breast Cancer or High Grade Serous Ovarian Cancer

118 enrolled

BreastGynecologic

Breast Neoplasms, Ovarian Neoplasms, Recurrence

NCT01735968 2020-12-21

A Dose-finding Study of a Combination of Imatinib and BYL719 in the Treatment of 3rd Line GIST Patients

56 enrolled

Sarcoma

3rd Line GIST

NCT01822613 2020-12-19

Study of Safety & Efficacy of the Combination of LJM716 & BYL719 in Patients With Previously Treated Esophageal Squamous Cell Carcinoma (ESCC)

48 enrolled

Esophageal Squamous Cell Carcinoma, Esophageal Neoplasms

NCT02088684 2020-12-17

Study of LEE011 With Fulvestrant and BYL719 or BKM120 in Advanced Breast Cancer

70 enrolled

Breast Neoplasms

NCT02144038 2020-12-17

Study of the Safety and Effectiveness of LGH447 and BYL719 in Patients With Relapsed and Refractory Multiple Myeloma

20 enrolled

Plasma cell

Multiple Myeloma, Recurrence

NCT02276027 2020-12-16

A Phase II, Open Label, Multiple Arm Study of AUY922, BYL719, INC280, LDK378 and MEK162 in Chinese Patients With Advanced Non-small Cell Lung Cancer

66 enrolled 18 charts

Thoracic

Adenocarcinoma of Lung

NCT01613950 2020-12-09

PI3K Inhibitor BYL719 in Combination With the HSP90 Inhibitor AUY922 in Patients With Advanced or Metastatic Gastric Cancer

18 enrolled

Stomach Neoplasms Esophageal Neoplasms Metastatic Gastric Cancer Mutated PI3KCA Protein Overexpressed HER2 Protein

NCT01928459 2020-12-09

Phase 1b Trial of BGJ398/BYL719 in Solid Tumors

62 enrolled

Acrocephalosyndactylia, Breast Neoplasms

NCT01387321 2020-12-08

A Study of BYL719 in Adult Patients With Advanced Solid Malignancies

33 enrolled

Other solid neoplasm

Advanced Solid Tumor

NCT02051751 2020-12-08

A Study to Evaluate the Potential Benefit of the Addition of BYL719 to Paclitaxel in the Treatment of Breast Cancer and Head-and-neck Cancer

19 enrolled

BreastHead & Neck

Breast Neoplasms, Head and Neck Neoplasms, Neoplasms

NCT02077933 2020-12-08

Study of Safety and Efficacy of Alpelisib With Everolimus or Alpelisib With Everolimus and Exemestane in Advanced Breast Cancer Patients, Renal Cell Cancer and Pancreatic Tumors

79 enrolled

BreastGenitourinary

Breast Neoplasms, Carcinoma, Renal Cell, Kidney Neoplasms, Neoplasms

NCT01219699 2020-09-22

A Study of BYL719 in Adult Patients With Advanced Solid Malignancies, Whose Tumors Have an Alteration of the PIK3CA Gene

BreastOther solid neoplasm

221 enrolled

Advanced Solid Tumors With an Alteration of the PIK3CA Gene

NCT02038010 2020-06-29

BYL719 + T-DM1 in HER2(+) Metastatic Breast Cancer Pts Who Progress on Prior Trastuzumab & Taxane Tx

17 enrolled 17 charts

Breast Neoplasms

NCT02058381 2020-03-09

B-YOND

40 enrolled

Pre-menopausal Breast Cancer

NCT01923168 2018-09-14

Study of Letrozole With or Without BYL719 or Buparlisib, for the Neoadjuvant Treatment of Postmenopausal Women

340 enrolled 39 charts

Breast Neoplasms

NCT01449058 2017-10-02

A Phase Ib Study of MEK162 Plus BYL719 in Adult Patients With Selected Advanced Solid Tumors