Therapy Detail

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Therapy Name Sapanisertib
Synonyms
Therapy Description

Sapanisertib (MLN0128) is an ATP-competitive mTOR kinase inhibitor that induces apoptosis and inhibits growth in tumor cells (PMID: 25519700).

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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
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
Unknown unknown prostate cancer not applicable Sapanisertib Phase II Actionable In a Phase II trial, Sapanisertib (MLN0128) treatment demonstrated limited efficacy, with a median time on treatment of 11 weeks and stable disease as best response (PMID: 29508246). 29508246
Unknown unknown prostate cancer not applicable Sapanisertib Preclinical Actionable In a preclinical study, Sapanisertib (MLN0128) inhibited cell proliferation, induced apoptosis, and prevented metastasis in xenograft models with prostate cancer (PMID: 22367541). 22367541
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
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
Unknown unknown malignant fibrous histiocytoma not applicable Sapanisertib Preclinical - Cell line xenograft Actionable In a preclinical study, treatment with Sapanisertib (MLN0128) resulted in growth suppression and arrest in a myxofibrosarcoma cell line in culture, and inhibited tumor growth in myxofibrosarcoma cell line xenograft models (PMID: 27577794). 27577794
Unknown unknown Advanced Solid Tumor not applicable Sapanisertib Phase I Actionable In a Phase I trial, Sapanisertib (MLN0128) demonstrated safety and some efficacy in patients with advanced solid tumors (Mol Cancer Ther 2013;12(11 Suppl):C252). detail...
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

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT02893930 Phase II Sapanisertib Sapanisertib in Treating Patients With Metastatic or Refractory Pancreatic Neuroendocrine Tumor That Cannot Be Removed by Surgery Active, not recruiting USA 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
NCT02465060 Phase II Erdafitinib Copanlisib Trametinib Crizotinib Sunitinib Sapanisertib Nivolumab AZD4547 Dasatinib Pertuzumab + Trastuzumab Dabrafenib + Trametinib Binimetinib Adavosertib Osimertinib Palbociclib Afatinib Capivasertib Defactinib GSK2636771 Vismodegib Ado-trastuzumab emtansine Larotrectinib Taselisib Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) Recruiting USA 2
NCT02725268 Phase II Paclitaxel Sapanisertib MLN1117 + Sapanisertib Phase 2 Study of MLN0128, Combination of MLN0128 With MLN1117, Paclitaxel and Combination of MLN0128 With Paclitaxel in Women With Endometrial Cancer Completed USA | CAN 8
NCT02514824 Phase Ib/II Sapanisertib MLN0128 in Recurrent/Metastatic Merkel Cell Carcinoma Completed USA 0
NCT02987959 Phase II Sapanisertib Study of TAK-228 (MLN0128) in Soft Tissue Sarcomas Active, not recruiting USA 0
NCT01058707 Phase I Sapanisertib Dose Escalation Study of MLN0128 in Subjects With Advanced Malignancies Completed USA 1
NCT02601209 Phase Ib/II Pazopanib Sapanisertib Sapanisertib or Pazopanib Hydrochloride in Treating Patients With Locally Advanced or Metastatic Sarcoma Active, not recruiting USA 0
NCT02091531 Phase II Sapanisertib Dual mTOR Inhibitor MLN0128 in Advanced Castration-Resistant Prostate Cancer (CRPC) Patients 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
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
NCT02417701 Phase II Sapanisertib Sapanisertib in Treating Patients With Stage IV or Recurrent Lung Cancer Completed USA 0
NCT02575339 Phase Ib/II Sorafenib Sapanisertib MLN0128 Compared to Sorafenib in Advanced or Metastatic Hepatocellular Carcinoma Active, not recruiting USA 0
NCT02133183 Phase I Sapanisertib TORC1/2 Inhibitor INK128 Before and After Surgery in Treating Patients With Recurrent Glioblastoma Active, not recruiting USA 0
NCT02724020 Phase II MLN1117 + Sapanisertib 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 | CAN 6
NCT02244463 Phase II Sapanisertib A Phase II Study of MLN0128 in Metastatic Anaplastic Thyroid Cancer Recruiting USA 0
NCT02484430 Phase II Sapanisertib TORC1/2 Inhibitor INK128 in Treating Patients With Relapsed and/or Refractory Acute Lymphoblastic Leukemia Active, not recruiting USA 0
NCT02197572 Phase I Sapanisertib Effect of MLN0128 on the QTc Interval in Participants With Advanced Solid Tumors Completed USA 0
NCT03097328 Phase II Sapanisertib Study of TAK-228 In Patients With Previously Treated Metastatic Renal Cell Carcinoma Recruiting USA 0


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