Therapy Detail

Therapy Name Sapanisertib
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|sapanisertib|TAK-228|MLN0128 mTOR Inhibitor 48 Sapanisertib (MLN0128) is an ATP-competitive mTOR kinase inhibitor that induces apoptosis and inhibits growth in tumor cells (PMID: 25519700).
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
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 mut RB1 mut SMAD4 mut TP53 mut skin cancer sensitive Sapanisertib Preclinical Actionable In a preclinical study, a skin cancer cell line harboring mutations in PTEN, RB1, SMAD4 and TP53 demonstrated sensitivity to Sapanisertib (MLN0128) in culture (PMID: 25261369). 25261369
KRAS G12D STK11 inact mut lung cancer sensitive Sapanisertib Preclinical Actionable In a preclinical study, Sapanisertib (MLN0128) inhibited lung tumor growth in mouse models with KRAS G12D and inactivation of STK11 (LKB1), and demonstrated limited efficacy in tumors with KRAS G12D and wild-type STK11 (PMID: 26574479). 26574479
Unknown unknown malignant fibroxanthoma 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...
PTEN mutant TP53 mutant 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
Clinical Trial Phase Therapies Title Recruitment Status
NCT03047213 Phase II Sapanisertib Sapanisertib in Treating Patients With Locally Advanced or Metastatic Bladder Cancer With TSC1 and/or TSC2 Mutations Recruiting
NCT02244463 Phase II Sapanisertib A Phase II Study of MLN0128 in Metastatic Anaplastic Thyroid Cancer Recruiting
NCT02417701 Phase II Sapanisertib TORC1/2 Inhibitor MLN0128 in Treating Patients With Stage IV or Recurrent Lung Cancer Recruiting
NCT02133183 Phase I Sapanisertib TORC1/2 Inhibitor INK128 Before and After Surgery in Treating Patients With Recurrent Glioblastoma Recruiting
NCT02484430 Phase II Sapanisertib TORC1/2 Inhibitor INK128 in Treating Patients With Relapsed and/or Refractory Acute Lymphoblastic Leukemia Active, not recruiting
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 Recruiting
NCT03097328 Phase II Sapanisertib Study of TAK-228 In Patients With Previously Treated Metastatic Renal Cell Carcinoma Recruiting
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 Active, not recruiting
NCT02893930 Phase II Sapanisertib Sapanisertib in Treating Patients With Metastatic or Refractory Pancreatic Neuroendocrine Tumor That Cannot Be Removed by Surgery Suspended
NCT02987959 Phase II Sapanisertib Study of TAK-228 (MLN0128) in Soft Tissue Sarcomas Recruiting
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 Active, not recruiting
NCT02575339 Phase Ib/II Sorafenib Sapanisertib MLN0128 Compared to Sorafenib in Advanced or Metastatic Hepatocellular Carcinoma Active, not recruiting
NCT02465060 Phase II Dabrafenib Trametinib Crizotinib Sunitinib Sapanisertib Nivolumab AZD4547 Dasatinib Binimetinib Adavosertib Osimertinib Trastuzumab Palbociclib Afatinib Capivasertib Defactinib GSK2636771 Vismodegib trastuzumab emtansine Larotrectinib Pertuzumab Taselisib Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) Recruiting
NCT02601209 Phase Ib/II Pazopanib Sapanisertib Sapanisertib or Pazopanib Hydrochloride in Treating Patients With Locally Advanced or Metastatic Sarcoma Active, not recruiting
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
NCT02514824 Phase Ib/II Sapanisertib MLN0128 in Recurrent/Metastatic Merkel Cell Carcinoma Active, not recruiting
NCT02091531 Phase II Sapanisertib Dual mTOR Inhibitor MLN0128 in Advanced Castration-Resistant Prostate Cancer (CRPC) Patients Completed
NCT01058707 Phase I Sapanisertib Dose Escalation Study of MLN0128 in Subjects With Advanced Malignancies Completed
NCT02197572 Phase I Sapanisertib Effect of MLN0128 on the QTc Interval in Participants With Advanced Solid Tumors Active, not recruiting