Clinical Trials Browser

Interventional × gedatolisib × Clear all

Genital Diseases, Male, Prostatic Diseases, Prostatic Neoplasms, Male Urogenital Diseases, Prostatic Neoplasms, Castration-Resistant

NCT03065062 2026-02-13

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

Phase 1 Suspended

75 enrolled

GastrointestinalGynecologicHead & Neck

Head and Neck Neoplasms, Neoplasms, Pancreatic Neoplasms, Endometrial Neoplasms

NCT05501886 2026-02-10

VIKTORIA-1

Phase 3 Active not recruiting

701 enrolled

Breast

Breast Neoplasms, Neoplasm Metastasis

NCT06757634 2026-02-05

Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2)

Phase 3 Recruiting

674 enrolled

Breast

Breast Neoplasms, Neoplasm Metastasis

NCT02438761 2025-09-08

5

Phase 2 Terminated

10 enrolled

MyeloidOther hematologic neoplasm

Myelodysplastic Syndromes, Leukemia, Myeloid, Acute

NCT03675893 2025-06-15

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

Phase 2 Recruiting

180 enrolled

Gynecologic

Ovarian Neoplasms, Endometrial Neoplasms

NCT03911973 2024-06-07

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

Phase 1/2 Active not recruiting

37 enrolled

Breast

Triple Negative Breast Neoplasms

NCT01920061 2022-09-13

A Study Of PF-05212384 In Combination With Other Anti-Tumor Agents and in Combination With Cisplatin in Patients With Triple Negative Breast Cancer in an Expansion Arm (TNBC)

Phase 1 Completed

110 enrolled 80 charts

Breast

Neoplasm Metastasis, Neoplasms, Triple Negative Breast Neoplasms

NCT02684032 2022-07-27

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

Phase 1 Completed

141 enrolled

Breast

Breast Neoplasms, Hereditary Sensory and Autonomic Neuropathies

NCT02626507 2022-02-09

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

Phase 1 Unknown

18 enrolled

Breast

Breast Neoplasms

NCT03698383 2021-02-18

Phase II Study of Herzuma® Plus Gedatolisib in Patients With HER-2 Positive Metastatic Breast Cancer

Phase 2 Unknown

15 enrolled

Breast

Breast Neoplasms

NCT03243331 2021-01-07

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

Phase 1 Completed

18 enrolled

Breast

Breast Neoplasms, Triple Negative Breast Neoplasms

NCT03400254 2020-04-28

GLACIER

Phase 1/2 Withdrawn

Breast

Breast Neoplasms

NCT02920450 2019-10-04

UF-STO-LUNG-002

Phase 1/2 Terminated

3 enrolled 8 charts

Thoracic

Carcinoma, Carcinoma, Non-Small-Cell Lung

NCT02069158 2019-05-21

IOSI-NDU-001

Phase 1 Completed

17 enrolled

BreastGynecologicHead & NeckThoracic

Squamous Cell Carcinoma of Head and Neck, Breast Neoplasms, Ovarian Neoplasms, Endometrial Neoplasms, Small Cell Lung Carcinoma

NCT01420081 2019-01-08

A Study Of Two Dual PI3K/mTOR Inhibitors, PF-04691502 And PF-05212384 In Patients With Recurrent Endometrial Cancer

Phase 2 Terminated

67 enrolled 37 charts

Gynecologic

Neoplasm Metastasis, Neoplasms, Recurrence, Uterine Neoplasms, Endometrial Neoplasms

NCT01925274 2019-01-08

A Study Of PF-05212384 Plus Irinotecan Vs Cetuximab Plus Irinotecan In Patients With KRAS And NRAS Wild Type Metastatic Colorectal Cancer

Phase 2 Terminated

19 enrolled 32 charts

Gastrointestinal

Colonic Neoplasms, Colorectal Neoplasms

NCT00940498 2018-11-02

B2151001

Phase 1 Completed

78 enrolled 26 charts

Tumor-Agnostic

Neoplasms

NCT01347866 2018-10-29

Clinical Study Of PI3K/mTOR Inhibitors In Combination With An Oral MEK Inhibitor Or Irinotecan In Patients With Advanced Cancer

Phase 1 Terminated

105 enrolled 64 charts

Advanced Cancer

NCT01937715 2016-08-18

A Study Of PF-05212384 Plus FOLFIRI Versus Bevacizumab Plus FOLFIRI In Metastatic Colorectal Cancer

Phase 1/2 Terminated

18 enrolled 23 charts

Gastrointestinal

Colorectal Neoplasms

Clinical Trials

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

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

VIKTORIA-1

Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2)

5

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

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

A Study Of PF-05212384 In Combination With Other Anti-Tumor Agents and in Combination With Cisplatin in Patients With Triple Negative Breast Cancer in an Expansion Arm (TNBC)

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

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

Phase II Study of Herzuma® Plus Gedatolisib in Patients With HER-2 Positive Metastatic Breast Cancer

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

GLACIER

UF-STO-LUNG-002

IOSI-NDU-001

A Study Of Two Dual PI3K/mTOR Inhibitors, PF-04691502 And PF-05212384 In Patients With Recurrent Endometrial Cancer

A Study Of PF-05212384 Plus Irinotecan Vs Cetuximab Plus Irinotecan In Patients With KRAS And NRAS Wild Type Metastatic Colorectal Cancer

B2151001

Clinical Study Of PI3K/mTOR Inhibitors In Combination With An Oral MEK Inhibitor Or Irinotecan In Patients With Advanced Cancer

A Study Of PF-05212384 Plus FOLFIRI Versus Bevacizumab Plus FOLFIRI In Metastatic Colorectal Cancer