Sapanisertib

Generic Name: Sapanisertib

Drug Type: Small Molecule

Chemical Formula: C_₁₅H_₁₅N_₇O

CAS Number: 1224844-38-5

Unique Ingredient Identifier: JGH0DF1U03

Background: Sapanisertib has been used in trials studying the treatment of HCC, Solid Tumor, Gliosarcoma, Liver Cancer, and Glioblastoma, among others.

Clinical Trials

Testing the Addition of an Anti-cancer Drug, Sapanisertib, to the Usual Chemotherapy Treatment (Cabozantinib) in Metastatic Liver Cell Cancer With a Change in Genes for the Protein β-Catenin

Phase 1

Not yet recruiting

Conditions: Advanced Hepatocellular Carcinoma
Metastatic Hepatocellular Carcinoma
Stage III Hepatocellular Carcinoma AJCC v8
Stage IV Hepatocellular Carcinoma AJCC v8

Interventions: Procedure: Biospecimen Collection
Drug: Cabozantinib S-malate
Procedure: Imaging Procedure
Drug: Sapanisertib

First Posted Date: 2025-02-06

Last Posted Date: 2025-05-20

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 92

Registration Number: NCT06811116

Sapanisertib and Serabelisib (PIKTOR) With Paclitaxel and a Substudy With Diet in Patients With Advanced/Recurrent Endometrial Cancer

Phase 2

Recruiting

Conditions: Endometrial Cancer

Interventions: Drug: Sapanisertib
Drug: Serabelisib
Drug: Paclitaxel

First Posted Date: 2024-06-17

Last Posted Date: 2025-03-17

Lead Sponsor: Faeth Therapeutics

Target Recruit Count: 40

Registration Number: NCT06463028

Locations: 🇺🇸
UC San Diego Moores Cancer Center, La Jolla, California, United States
🇺🇸
Mount Sinai Comprehensive Cancer Center, Miami Beach, Florida, United States
🇺🇸
Florida Cancer Specialists, North, Saint Petersburg, Florida, United States

and more 7 locations

Testing MLN0128 (TAK-228) as Potentially Targeted Treatment in Cancers With TSC1 or TSC2 Genetic Changes (MATCH - Subprotocol M)

Phase 2

Active, not recruiting

Conditions: Advanced Lymphoma
Advanced Malignant Solid Neoplasm
Refractory Lymphoma
Refractory Malignant Solid Neoplasm
Refractory Multiple Myeloma

Interventions: Procedure: Biopsy Procedure
Procedure: Biospecimen Collection
Procedure: Computed Tomography
Procedure: Magnetic Resonance Imaging
Drug: Sapanisertib

First Posted Date: 2024-04-30

Last Posted Date: 2025-05-06

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 49

Registration Number: NCT06390865

Locations: 🇺🇸
ECOG-ACRIN Cancer Research Group, Philadelphia, Pennsylvania, United States

Testing MLN0128 (TAK-228) as Potentially Targeted Treatment in Cancers With mTOR Genetic Changes (MATCH - Subprotocol L)

Phase 2

Active, not recruiting

Conditions: Advanced Malignant Solid Neoplasm
Refractory Lymphoma
Refractory Multiple Myeloma
Advanced Lymphoma
Refractory Malignant Solid Neoplasm

Interventions: Procedure: Biopsy Procedure
Procedure: Biospecimen Collection
Procedure: Computed Tomography
Procedure: Magnetic Resonance Imaging
Drug: Sapanisertib

First Posted Date: 2024-04-26

Last Posted Date: 2025-05-01

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 35

Registration Number: NCT06385496

Locations: 🇺🇸
ECOG-ACRIN Cancer Research Group, Philadelphia, Pennsylvania, United States

A Study of Sapanisertib in Relapsed/Refractory NFE2L2-Mutated and Wild-Type Squamous Non-Small Cell Lung Cancer

Phase 2

Terminated

Conditions: NFE2L2 Gene Mutation
Squamous Non-Small Cell Neoplasm of Lung
Non-Small Cell Lung Cancer
Squamous Non-small-cell Lung Cancer

Interventions: Drug: sapanisertib

First Posted Date: 2022-03-11

Last Posted Date: 2025-04-24

Lead Sponsor: Faeth Therapeutics

Target Recruit Count: 7

Registration Number: NCT05275673

Locations: 🇺🇸
Memorial Sloan Kettering Cancer Center - Thoracic, New York, New York, United States
🇺🇸
UC Davis Comprehensive Cancer Center, Davis, California, United States
🇺🇸
Providence Medical Group Santa Rosa - Cancer Center, Santa Rosa, California, United States

and more 10 locations

Sapanisertib and Nivolumab for the Treatment of Stage I-IV Non-small Cell Lung Cancer in Patients Who Have Progressed on Prior PD-1/PD-L1 Inhibitor Therapy, I-OVERCOME Study

Phase 1

Withdrawn

Conditions: Lung Non-Small Cell Carcinoma
Stage I Lung Cancer AJCC v8
Stage II Lung Cancer AJCC v8
Stage IIA Lung Cancer AJCC v8
Recurrent Lung Non-Small Cell Carcinoma
Stage III Lung Cancer AJCC v8
Stage IIIA Lung Cancer AJCC v8
Stage IV Lung Cancer AJCC v8
Stage IVA Lung Cancer AJCC v8
Stage IIB Lung Cancer AJCC v8

Interventions: Biological: Nivolumab
Drug: Sapanisertib

First Posted Date: 2021-08-26

Last Posted Date: 2022-05-27

Lead Sponsor: M.D. Anderson Cancer Center

Registration Number: NCT05022394

Osimertinib in Combination With Alisertib or Sapanisertib for the Treatment of Osimertinib-Resistant EGFR Mutant Stage IIIB or IV Non-Small Cell Lung Cancer

Phase 1

Completed

Conditions: Stage IIIB Lung Cancer AJCC v8
Stage IV Lung Cancer AJCC v8
Stage IVB Lung Cancer AJCC v8
Recurrent Lung Non-Small Cell Carcinoma
Stage IVA Lung Cancer AJCC v8

Interventions: Drug: Alisertib
Drug: Osimertinib
Drug: Sapanisertib

First Posted Date: 2020-07-21

Last Posted Date: 2024-06-04

Lead Sponsor: M.D. Anderson Cancer Center

Target Recruit Count: 37

Registration Number: NCT04479306

Locations: 🇺🇸
M D Anderson Cancer Center, Houston, Texas, United States

Testing of TAK228 (MLN0128, Sapanisertib) Plus Docetaxel to the Usual Standard of Care for Advanced Squamous Cell Lung Cancer (A Lung-MAP Treatment Trial)

Phase 2

Withdrawn

Conditions: Lung Squamous Cell Carcinoma
Recurrent Lung Carcinoma
Stage IV Lung Cancer AJCC v8
Stage IVA Lung Cancer AJCC v8
Stage IVB Lung Cancer AJCC v8

Interventions: Drug: Dexamethasone
Drug: Docetaxel
Biological: Ramucirumab
Drug: Sapanisertib

First Posted Date: 2020-02-13

Last Posted Date: 2020-11-20

Lead Sponsor: SWOG Cancer Research Network

Registration Number: NCT04267913

Testing of the Anti Cancer Drugs CB-839 HCl (Telaglenastat) and MLN0128 (Sapanisertib) in Advanced Stage Non-small Cell Lung Cancer

Phase 1

Active, not recruiting

Conditions: Metastatic Lung Non-Small Cell Carcinoma
Stage IVA Lung Cancer AJCC v8
Metastatic Malignant Neoplasm in the Brain
Stage IV Lung Cancer AJCC v8
Leptomeningeal Neoplasm
Stage IVB Lung Cancer AJCC v8
Recurrent Lung Non-Small Cell Carcinoma

Interventions: Drug: Sapanisertib
Drug: Telaglenastat Hydrochloride

First Posted Date: 2020-01-31

Last Posted Date: 2025-05-21

Lead Sponsor: National Cancer Institute (NCI)

Target Recruit Count: 85

Registration Number: NCT04250545

Locations: 🇺🇸
City of Hope at Irvine Lennar, Irvine, California, United States
🇺🇸
Los Angeles General Medical Center, Los Angeles, California, United States
🇺🇸
Keck Medicine of USC Koreatown, Los Angeles, California, United States

and more 4 locations

Dual mTorc Inhibition in advanCed/Recurrent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer (of Clear Cell, Endometrioid and High Grade Serous Type, and Carcinosarcoma)

Phase 2

Conditions: Ovarian Cancer
Ovarian Neoplasms
Ovarian Carcinosarcoma
Ovarian Serous Adenocarcinoma
Ovarian Endometrioid Adenocarcinoma
Ovarian Clear Cell Adenocarcinoma
Fallopian Tube Cancer
Fallopian Tube Neoplasms
Primary Peritoneal Carcinoma
Primary Peritoneal Serous Adenocarcinoma

Interventions: Drug: Paclitaxel
Drug: TAK228

First Posted Date: 2018-08-27

Last Posted Date: 2022-03-11

Lead Sponsor: Imperial College London

Target Recruit Count: 134

Registration Number: NCT03648489

Locations: 🇩🇪
KEM Kliniken Essen-Mitte, Essen, Germany
🇬🇧
Southampton General Hospital, Southampton, United Kingdom
🇬🇧
Imperial College Healthcare NHS Trust, London, Greater London, United Kingdom

and more 11 locations

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