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Last Updated: April 9, 2025

CLINICAL TRIALS PROFILE FOR SAPANISERTIB

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Clinical Trials for Sapanisertib

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Trial ID	Title	Status	Sponsor	Phase	Summary

NCT01899053 ↗	A Safety and Pharmacokinetic Study of TAK-228 in Combination With TAK-117 in Adult Participants With Advanced Nonhematologic Malignancies	Completed	Millennium Pharmaceuticals, Inc.	Phase 1	The purpose of this study was to evaluate the safety and to determine dose-limiting toxicities (DLTs), maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D), and dosing schedules of oral TAK-228+TAK-117. It also evaluated the single- and multiple-dose plasma pharmacokinetics (PK) of TAK-228+TAK-117 in participants with advanced nonhematologic malignancies.
NCT02049957 ↗	Safety and Efficacy Study of Sapanisertib in Combination With Exemestane or Fulvestrant in Postmenopausal Women With Estrogen Receptor Positive/Human Epidermal Growth Factor Receptor 2 Negative (ER+/HER2-) Metastatic Breast Cancer	Completed	Millennium Pharmaceuticals, Inc.	Phase 2	This is a phase 1b/2 study of the safety and efficacy of sapanisertib (MLN0128) in combination with exemestane or fulvestrant therapy in women with estrogen receptor positive/human epidermal growth factor receptor 2 negative (ER+/HER2-) advanced or metastatic breast cancer who progressed on treatment with everolimus in combination with exemestane or fulvestrant.
NCT02133183 ↗	Sapanisertib Before and After Surgery in Treating Patients With Recurrent Glioblastoma	Active, not recruiting	National Cancer Institute (NCI)	Phase 1	This partially randomized pilot phase I trial studies how much sapanisertib reaches the brain tumor and how well it works when given before and after surgery in treating patients with glioblastoma that has grown or come back and requires surgery. Sapanisertib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
>Trial ID	>Title	>Status	>Sponsor	>Phase	>Summary

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Clinical Trial Conditions for Sapanisertib

Condition Name

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Condition Name
Intervention	Trials
Stage IVA Lung Cancer AJCC v8	4
Recurrent Lung Non-Small Cell Carcinoma	4
Stage IV Lung Cancer AJCC v8	4
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Condition MeSH

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Condition MeSH
Intervention	Trials
Carcinoma	11
Neoplasms	9
Lung Neoplasms	8
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Clinical Trial Locations for Sapanisertib

Trials by Country

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Trials by Country
Location	Trials
United States	237
United Kingdom	9
Spain	9
Germany	7
Canada	5
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Trials by US State

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Trials by US State
Location	Trials
Texas	13
California	10
New York	9
Florida	9
Tennessee	8
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Clinical Trial Progress for Sapanisertib

Clinical Trial Phase

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Clinical Trial Phase
Clinical Trial Phase	Trials
Phase 2	10
Phase 1/Phase 2	3
Phase 1	11
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Clinical Trial Status

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Clinical Trial Status
Clinical Trial Phase	Trials
Active, not recruiting	8
Completed	7
Recruiting	6
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Clinical Trial Sponsors for Sapanisertib

Sponsor Name

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Sponsor Name
Sponsor	Trials
National Cancer Institute (NCI)	16
Millennium Pharmaceuticals, Inc.	7
M.D. Anderson Cancer Center	4
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Sponsor Type

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Sponsor Type
Sponsor	Trials
NIH	16
Other	11
Industry	10
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