Success Metrics

Clinical Success Rate
56.0%

Based on 14 completed trials

Completion Rate
56%(14/25)
Active Trials
24(41%)
Results Posted
79%(11 trials)
Terminated
11(19%)

Phase Distribution

Ph not_applicable
1
2%
Ph phase_4
1
2%
Ph phase_2
24
41%
Ph phase_3
9
16%
Ph phase_1
14
24%
Ph early_phase_1
1
2%

Phase Distribution

15

Early Stage

24

Mid Stage

10

Late Stage

Phase Distribution50 total trials
Early Phase 1First-in-human
1(2.0%)
Phase 1Safety & dosage
14(28.0%)
Phase 2Efficacy & side effects
24(48.0%)
Phase 3Large-scale testing
9(18.0%)
Phase 4Post-market surveillance
1(2.0%)
N/ANon-phased studies
1(2.0%)

Highest Phase Reached

Phase 4

Trial Status & Enrollment

Completion Rate

50.0%

14 of 28 finished

Non-Completion Rate

50.0%

14 ended early

Currently Active

24

trials recruiting

Total Trials

58

all time

Status Distribution
Active(24)
Completed(14)
Terminated(14)
Other(6)

Detailed Status

Active, not recruiting15
Completed14
Terminated11
Recruiting9
unknown6
Withdrawn3

Development Timeline

Analytics

Development Status

Total Trials
58
Active
24
Success Rate
56.0%
Most Advanced
Phase 4

Trials by Phase

Early Phase 11 (2.0%)
Phase 114 (28.0%)
Phase 224 (48.0%)
Phase 39 (18.0%)
Phase 41 (2.0%)
N/A1 (2.0%)

Trials by Status

withdrawn35%
recruiting916%
active_not_recruiting1526%
unknown610%
terminated1119%
completed1424%

Recent Activity

Clinical Trials (58)

Showing 20 of 58 trialsScroll for more
NCT05948943Phase 2

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

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
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
NCT05564377Phase 2

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

Recruiting
NCT05143229Phase 1

Alpelisib And Sacituzumab Govitecan For Treatment Of Breast Cancer

Active Not Recruiting
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
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
NCT04589650Phase 2

Study Assessing the Efficacy, Safety and PK of Alpelisib (BYL719) in Pediatric and Adult Patients With PIK3CA-related Overgrowth Spectrum

Active Not Recruiting
NCT04085653

Managed Access Programs for BYL719, Alpelisib

Unknown
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
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
NCT04980833Phase 2

Study Assessing Long-term Safety and Efficacy of Alpelisib in Patients With PIK3CA-Related Overgrowth Spectrum (PROS) Who Previously Participated in Study CBYL719F12002 (EPIK-P1)

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
NCT05230810Phase 1

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

Active Not Recruiting
NCT04729387Phase 3

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

Terminated
NCT05101564Phase 2

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

Completed
NCT05501886Phase 3

Gedatolisib Plus Fulvestrant With or Without Palbociclib vs Standard-of-Care for the Treatment of Patients With Advanced or Metastatic HR+/HER2- Breast Cancer (VIKTORIA-1)

Active Not Recruiting
NCT05933395Phase 2

Genetically-informed Therapy for ER+ Breast Cancer Post-CDK4/6 Inhibitor

Recruiting

Drug Details

Intervention Type
DRUG
Total Trials
58