Success Metrics

Clinical Success Rate
66.7%

Based on 2 completed trials

Completion Rate
67%(2/3)
Active Trials
4(36%)
Results Posted
50%(1 trials)
Terminated
1(9%)

Phase Distribution

Ph phase_1
8
73%
Ph phase_2
1
9%
Ph phase_3
1
9%

Phase Distribution

8

Early Stage

1

Mid Stage

1

Late Stage

Phase Distribution10 total trials
Phase 1Safety & dosage
8(80.0%)
Phase 2Efficacy & side effects
1(10.0%)
Phase 3Large-scale testing
1(10.0%)

Highest Phase Reached

Phase 3

Trial Status & Enrollment

Completion Rate

50.0%

2 of 4 finished

Non-Completion Rate

50.0%

2 ended early

Currently Active

4

trials recruiting

Total Trials

11

all time

Status Distribution
Active(4)
Completed(2)
Terminated(2)
Other(3)

Detailed Status

Recruiting2
unknown2
Completed2
Active, not recruiting2
Suspended1
Terminated1

Development Timeline

Analytics

Development Status

Total Trials
11
Active
4
Success Rate
66.7%
Most Advanced
Phase 3

Trials by Phase

Phase 18 (80.0%)
Phase 21 (10.0%)
Phase 31 (10.0%)

Trials by Status

recruiting218%
suspended19%
terminated19%
unknown218%
completed218%
active_not_recruiting218%
withdrawn19%

Recent Activity

4 active trials
Showing 5 of 11
recruitingphase_1

Gedatolisib in Combination With Darolutamide in Metastatic Castration-Resistant Prostate Cancer

NCT06190899
suspendedphase_1

Study of the CDK4/6 Inhibitor Palbociclib (PD-0332991) in Combination With the PI3K/mTOR Inhibitor Gedatolisib (PF-05212384) for Patients With Advanced Squamous Cell Lung, Pancreatic, Head & Neck and Other Solid Tumors

NCT03065062
active_not_recruitingphase_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)

NCT05501886
recruitingphase_2

RESOLVE: Abemaciclib + Letrozole +/- Metformin, Zotatifin, or Gedatolisib in Endometrial or Low-Grade Serous Ovarian Cancer

NCT03675893
unknown

Expanded Access Protocol for Subjects Previously Treated With Gedatolisib in B2151009

NCT05134922
View all 11 trials

Clinical Trials (11)

Showing 11 of 11 trials
NCT06190899Phase 1

Gedatolisib in Combination With Darolutamide in Metastatic Castration-Resistant Prostate Cancer

Recruiting
NCT03065062Phase 1

Study of the CDK4/6 Inhibitor Palbociclib (PD-0332991) in Combination With the PI3K/mTOR Inhibitor Gedatolisib (PF-05212384) for Patients With Advanced Squamous Cell Lung, Pancreatic, Head & Neck and Other Solid Tumors

Suspended
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
NCT03675893Phase 2

RESOLVE: Abemaciclib + Letrozole +/- Metformin, Zotatifin, or Gedatolisib in Endometrial or Low-Grade Serous Ovarian Cancer

Recruiting
NCT05134922

Expanded Access Protocol for Subjects Previously Treated With Gedatolisib in B2151009

Unknown
NCT03911973Phase 1

Gedatolisib Plus Talazoparib in Advanced Triple Negative or BRCA1/2 Positive, HER2 Negative Breast Cancers

Active Not Recruiting
NCT02684032Phase 1

A Study To Assess The Tolerability And Clinical Activity Of Gedatolisib In Combination With Palbociclib/Letrozole Or Palbociclib/Fulvestrant In Women With Metastatic Breast Cancer

Completed
NCT02626507Phase 1

Phase I Study of Combination of Gedatolisib With Palbociclib and Faslodex in Patients With ER+/HER2- Breast Cancer

Unknown
NCT03243331Phase 1

An Initial Safety Study of Gedatolisib Plus PTK7-ADC for Metastatic Triple-negative Breast Cancer

Completed
NCT03400254Phase 1

Gedatolisib, Hydroxychloroquine or the Combination for Prevention of Recurrent Breast Cancer ("GLACIER")

Withdrawn
NCT02920450Phase 1

Study of Paclitaxel, Carboplatin, and PF-05212384 in Advanced or Metastatic NSCLC (UF-STO-LUNG-002)

Terminated

All 11 trials loaded

Drug Details

Intervention Type
DRUG
Total Trials
11