Success Metrics

Clinical Success Rate
52.0%

Based on 13 completed trials

Completion Rate
52%(13/25)
Active Trials
24(41%)
Results Posted
115%(15 trials)
Terminated
12(20%)

Phase Distribution

Ph not_applicable
1
2%
Ph phase_1
14
24%
Ph early_phase_1
1
2%
Ph phase_3
9
15%
Ph phase_2
25
42%
Ph phase_4
1
2%

Phase Distribution

15

Early Stage

25

Mid Stage

10

Late Stage

Phase Distribution51 total trials
Early Phase 1First-in-human
1(2.0%)
Phase 1Safety & dosage
14(27.5%)
Phase 2Efficacy & side effects
25(49.0%)
Phase 3Large-scale testing
9(17.6%)
Phase 4Post-market surveillance
1(2.0%)
N/ANon-phased studies
1(2.0%)

Highest Phase Reached

Phase 4

Trial Status & Enrollment

Completion Rate

46.4%

13 of 28 finished

Non-Completion Rate

53.6%

15 ended early

Currently Active

24

trials recruiting

Total Trials

59

all time

Status Distribution
Active(25)
Completed(13)
Terminated(15)
Other(6)

Detailed Status

Active, not recruiting16
Completed13
Terminated12
Recruiting8
unknown6
Withdrawn3

Development Timeline

Analytics

Development Status

Total Trials
59
Active
24
Success Rate
52.0%
Most Advanced
Phase 4

Trials by Phase

Early Phase 11 (2.0%)
Phase 114 (27.5%)
Phase 225 (49.0%)
Phase 39 (17.6%)
Phase 41 (2.0%)
N/A1 (2.0%)

Trials by Status

not_yet_recruiting12%
recruiting814%
terminated1220%
completed1322%
active_not_recruiting1627%
unknown610%
withdrawn35%

Recent Activity

Clinical Trials (59)

Showing 20 of 59 trialsScroll for more
NCT05090358Phase 2

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

Active Not Recruiting
NCT05564377Phase 2

Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial

Recruiting
NCT05038735Phase 3

Study to Assess the Efficacy and Safety of Alpelisib Plus Fulvestrant in Participants With HR-positive (HR+), HER2-negative, Advanced Breast Cancer After Treatment With a CDK4/6 Inhibitor and an Aromatase Inhibitor.

Active Not Recruiting
NCT04251533Phase 3

Study Assessing the Efficacy and Safety of Alpelisib + Nab-paclitaxel in Subjects With Advanced TNBC Who Carry Either a PIK3CA Mutation or Have PTEN Loss

Terminated
NCT05948943Phase 2

Alpelisib in Pediatric and Adult Patients With Lymphatic Malformations Associated With a PIK3CA Mutation.

Recruiting
NCT03439046Phase 3

Study of the Molecular Features of Postmenopausal Women With HR+ HER2-negative aBC on First-line Treatment With Ribociclib and Letrozole and, in Patients With a PIK3CA Mutation, on Second-line Treatment With Alpelisib Plus Fulvestrant

Terminated
NCT05631795Phase 4

Study to Assess the Safety of Alpelisib Plus Fulvestrant, in Men and Post-menopausal Women With HR-positive, HER2-negative, Advanced Breast Cancer (aBC) With PIK3CA Mutation, Whose Disease Progressed on or After Endocrine Treatment

Completed
NCT06997588Phase 2

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)

Recruiting
NCT04524000Phase 2

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

Active Not Recruiting
NCT04216472Phase 2

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

Terminated
NCT07679269Phase 2

Roll-Over Study of Alpelisib (BYL719) for Continued Access and Long-Term Safety.

Not Yet Recruiting
NCT05646862Phase 3

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

Active Not Recruiting
NCT04188548Phase 1

A Study of LY3484356 in Participants With Advanced or Metastatic Breast Cancer or Endometrial Cancer

Active Not Recruiting
NCT05563220Phase 1

Open-Label Umbrella Study To Evaluate Safety And Efficacy Of Elacestrant In Various Combination In Participants With Metastatic Breast Cancer

Active Not Recruiting
NCT04544189Phase 2

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

Active Not Recruiting
NCT04208178Phase 3

Study of Alpelisib (BYL719) in Combination With Trastuzumab and Pertuzumab as Maintenance Therapy in Patients With HER2-positive Advanced Breast Cancer With a PIK3CA Mutation

Active Not Recruiting
NCT04997902Phase 1

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

Completed
NCT04729387Phase 3

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

Terminated
NCT06083038

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

Completed
NCT05983159Phase 2

A Trial of Targeted Therapies for Patients With Slow-Flow or Fast-Flow Vascular Malformations

Recruiting

Drug Details

Intervention Type
DRUG
Total Trials
59