Success Metrics

Clinical Success Rate
87.5%

Based on 21 completed trials

Completion Rate
88%(21/24)
Active Trials
1(4%)
Results Posted
24%(5 trials)
Terminated
3(11%)

Phase Distribution

Ph phase_2
5
19%
Ph not_applicable
1
4%
Ph phase_1
21
78%

Phase Distribution

21

Early Stage

5

Mid Stage

0

Late Stage

Phase Distribution27 total trials
Phase 1Safety & dosage
21(77.8%)
Phase 2Efficacy & side effects
5(18.5%)
N/ANon-phased studies
1(3.7%)

Highest Phase Reached

Phase 2

Trial Status & Enrollment

Completion Rate

84.0%

21 of 25 finished

Non-Completion Rate

16.0%

4 ended early

Currently Active

1

trials recruiting

Total Trials

27

all time

Status Distribution
Active(1)
Completed(21)
Terminated(4)
Other(1)

Detailed Status

Completed21
Terminated3
Active, not recruiting1
unknown1
Withdrawn1

Development Timeline

Analytics

Development Status

Total Trials
27
Active
1
Success Rate
87.5%
Most Advanced
Phase 2

Trials by Phase

Phase 121 (77.8%)
Phase 25 (18.5%)
N/A1 (3.7%)

Trials by Status

terminated311%
active_not_recruiting14%
completed2178%
unknown14%
withdrawn14%

Recent Activity

1 active trials
Showing 5 of 27
active_not_recruitingphase_1

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

NCT01872260
completednot_applicable

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

NCT03138070
completedphase_1

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

NCT01870505
completedphase_1

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

NCT01300962
completedphase_1

Trial of AEB071 in Combination With BYL719 in Patients With Melanoma

NCT02273219
View all 27 trials

Clinical Trials (27)

Showing 20 of 27 trialsScroll for more
NCT01872260Phase 1

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

Active Not Recruiting
NCT03138070Not Applicable

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

Completed
NCT01870505Phase 1

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

Completed
NCT01300962Phase 1

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

Completed
NCT02273219Phase 1

Trial of AEB071 in Combination With BYL719 in Patients With Melanoma

Completed
NCT02506556Phase 2

Phosphatidylinositol 3-kinase (PI3K) Alpha iNhibition In Advanced Breast Cancer

Completed
NCT02734615Phase 1

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

Terminated
NCT03292250Phase 2

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

Completed
NCT02282371Phase 1

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

Completed
NCT02167854Phase 1

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

Completed
NCT01719380Phase 2

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

Completed
NCT02537223Phase 1

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

Completed
NCT02155088Phase 1

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

Completed
NCT02550743Phase 1

BrUOG 302:BYL719, Capecitabine and Radiation for Rectal Cancer: A Brown University Oncology Research Group Study

Terminated
NCT01822613Phase 1

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

Completed
NCT02088684Phase 1

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

Completed
NCT02144038Phase 1

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

Completed
NCT02276027Phase 2

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

Completed
NCT01613950Phase 1

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

Completed
NCT01928459Phase 1

Phase 1b Trial of BGJ398/BYL719 in Solid Tumors

Completed

Drug Details

Intervention Type
DRUG
Total Trials
27