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Drug Name	Trade Name	Synonyms	Drug Classes	Drug Description
Sapanisertib		INK128\|INK-128\|TAK-228\|MLN0128\|MLN-0128	mTOR Inhibitor 51	Sapanisertib (MLN0128) is an ATP-competitive mTOR kinase inhibitor that induces apoptosis and inhibits growth in tumor cells (PMID: 25519700, PMID: 32488989).

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Molecular Profile	Indication/Tumor Type	Response Type	Therapy Name	Approval Status	Evidence Type	Efficacy Evidence	References
PIK3CA mutant	breast cancer	sensitive	Sapanisertib	Preclinical	Actionable	In a preclinical study, Sapanisertib (MLN0128) demonstrated efficacy in PIK3CA mutant breast cancer xenograft models (PMID: 23085766).	23085766
PIK3CA mutant	Advanced Solid Tumor	sensitive	Sapanisertib	Preclinical	Actionable	In a preclinical study, human cancer cell lines harboring PIK3CA mutations were sensitive to Sapanisertib (MLN0128) as demonstrated by significant growth inhibition (PMID: 25261369).	25261369
CDKN2A mut PIK3CA mut	breast cancer	sensitive	Sapanisertib	Preclinical	Actionable	In a preclinical study, a breast cancer cell line harboring mutations in PIK3CA and CDKN2A demonstrated sensitivity to Sapanisertib (MLN0128) in culture (PMID: 25261369).	25261369
PTEN mut TP53 mut	skin cancer	sensitive	Sapanisertib	Preclinical	Actionable	In a preclinical study, a skin cancer cell line harboring mutations in PTEN and TP53 demonstrated sensitivity to Sapanisertib (MLN0128) in culture (PMID: 25261369).	25261369
PTEN mutant	breast cancer	sensitive	Sapanisertib	Preclinical	Actionable	In a preclinical study, Sapanisertib (MLN0128) induced apoptosis and inhibited MTORC1 signaling in breast cancer cells harboring a PTEN mutation (PMID: 25261369).	25261369

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Clinical Trial	Phase	Therapies	Title	Recruitment Status	Covered Countries	Other Countries
NCT02244463	Phase II	Sapanisertib	A Phase II Study of MLN0128 in Metastatic Anaplastic Thyroid Cancer	Completed	USA	0
NCT01058707	Phase I	Sapanisertib	Dose Escalation Study of MLN0128 in Subjects With Advanced Malignancies	Completed	USA \| ESP	0
NCT02197572	Phase I	Sapanisertib	Effect of MLN0128 on the QTc Interval in Participants With Advanced Solid Tumors	Completed	USA	0
NCT03047213	Phase II	Sapanisertib	Sapanisertib in Treating Patients With Locally Advanced or Metastatic Bladder Cancer With TSC1 and/or TSC2 Mutations	Active, not recruiting	USA	0
NCT03097328	Phase II	Sapanisertib	Study of TAK-228 In Patients With Previously Treated Metastatic Renal Cell Carcinoma	Completed	USA	0
NCT02091531	Phase II	Sapanisertib	Dual mTOR Inhibitor MLN0128 in Advanced Castration-Resistant Prostate Cancer (CRPC) Patients	Completed	USA	0
NCT02575339	Phase Ib/II	Sorafenib Sapanisertib	MLN0128 Compared to Sorafenib in Advanced or Metastatic Hepatocellular Carcinoma	Terminated	USA	0
NCT02601209	Phase Ib/II	Pazopanib Sapanisertib	Sapanisertib or Pazopanib Hydrochloride in Treating Patients With Locally Advanced or Metastatic Sarcoma	Terminated	USA	0
NCT02619669	Phase I	Sapanisertib Letrozole	Neoadjuvant Run-In Study With TAK-228 (MLN0128) Followed by Letrozole/TAK-228 (MLN0128) in Women With High-Risk ER+/HER2- Breast Cancer	Withdrawn	USA	0
NCT02514824	Phase Ib/II	Sapanisertib	MLN0128 in Recurrent/Metastatic Merkel Cell Carcinoma	Completed	USA	0
NCT02724020	Phase II	Sapanisertib + Serabelisib Sapanisertib Everolimus	MLN0128 and MLN0128 + MLN1117 Compared With Everolimus in the Treatment of Adults With Advanced or Metastatic Clear-Cell Renal Cell Carcinoma	Completed	USA \| POL \| ITA \| GBR \| FRA \| ESP \| CZE \| CAN	0
NCT02465060	Phase II	Erdafitinib Trametinib Crizotinib Sapanisertib Fexagratinib Dasatinib Osimertinib Palbociclib Capivasertib Larotrectinib Ulixertinib Nivolumab + Relatlimab Copanlisib Sunitinib Nivolumab Pertuzumab + Trastuzumab Ipatasertib Dabrafenib + Trametinib Binimetinib Adavosertib Afatinib Defactinib GSK2636771 Vismodegib Ado-trastuzumab emtansine Taselisib	Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)	Active, not recruiting	USA	2
NCT02893930	Phase II	Sapanisertib	Sapanisertib in Treating Patients With Metastatic or Refractory Pancreatic Neuroendocrine Tumor That Cannot Be Removed by Surgery	Completed	USA	0
NCT02987959	Phase II	Sapanisertib	Study of TAK-228 (MLN0128) in Soft Tissue Sarcomas	Terminated	USA	0
NCT05275673	Phase II	Sapanisertib	A Study of Sapanisertib in Relapsed/Refractory NFE2L2-Mutated and Wild-Type Squamous Non-Small Cell Lung Cancer	Terminated	USA	0
NCT02417701	Phase II	Sapanisertib	Sapanisertib in Treating Patients With Stage IV or Recurrent Lung Cancer	Completed	USA	0
NCT02133183	Phase I	Sapanisertib	TORC1/2 Inhibitor INK128 Before and After Surgery in Treating Patients With Recurrent Glioblastoma	Terminated	USA	0
NCT02484430	Phase II	Sapanisertib	TORC1/2 Inhibitor INK128 in Treating Patients With Relapsed and/or Refractory Acute Lymphoblastic Leukemia	Completed	USA	0
NCT02725268	Phase II	Paclitaxel Sapanisertib Sapanisertib + Serabelisib	Phase 2 Study of MLN0128, Combination of MLN0128 With MLN1117, Paclitaxel and Combination of MLN0128 With Paclitaxel in Women With Endometrial Cancer	Completed	USA \| NOR \| NLD \| ITA \| GBR \| ESP \| DEU \| CAN \| BEL \| AUS	0
NCT02412722	Phase I	Sapanisertib Paclitaxel	Safety, Tolerability, and Pharmacokinetics of MLN0128 as a Single Agent and in Combination With Paclitaxel in Adults With Advanced Nonhematologic Malignancies	Completed	USA	0

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