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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). |
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). |
Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
---|---|---|---|---|---|---|---|
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... |
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 |
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 |
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 |
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 |
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 |
Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
---|---|---|---|---|---|---|
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 |
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 |
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 |
NCT02417701 | Phase II | Sapanisertib | Sapanisertib in Treating Patients With Stage IV or Recurrent Lung Cancer | Completed | USA | 0 |
NCT02987959 | Phase II | Sapanisertib | Study of TAK-228 (MLN0128) in Soft Tissue Sarcomas | Active, not recruiting | USA | 0 |
NCT02514824 | Phase Ib/II | Sapanisertib | MLN0128 in Recurrent/Metastatic Merkel Cell Carcinoma | Completed | USA | 0 |
NCT02197572 | Phase I | Sapanisertib | Effect of MLN0128 on the QTc Interval in Participants With Advanced Solid Tumors | Completed | USA | 0 |
NCT02091531 | Phase II | Sapanisertib | Dual mTOR Inhibitor MLN0128 in Advanced Castration-Resistant Prostate Cancer (CRPC) Patients | Completed | USA | 0 |
NCT03097328 | Phase II | Sapanisertib | Study of TAK-228 In Patients With Previously Treated Metastatic Renal Cell Carcinoma | 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 |
NCT02575339 | Phase Ib/II | Sorafenib Sapanisertib | MLN0128 Compared to Sorafenib in Advanced or Metastatic Hepatocellular Carcinoma | 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 |
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 |
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 |
NCT02601209 | Phase Ib/II | Pazopanib Sapanisertib | Sapanisertib or Pazopanib Hydrochloride in Treating Patients With Locally Advanced or Metastatic Sarcoma | Active, not recruiting | USA | 0 |
NCT02244463 | Phase II | Sapanisertib | A Phase II Study of MLN0128 in Metastatic Anaplastic Thyroid Cancer | Recruiting | 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 |
NCT02484430 | Phase II | Sapanisertib | TORC1/2 Inhibitor INK128 in Treating Patients With Relapsed and/or Refractory Acute Lymphoblastic Leukemia | Active, not recruiting | USA | 0 |
NCT01058707 | Phase I | Sapanisertib | Dose Escalation Study of MLN0128 in Subjects With Advanced Malignancies | Completed | USA | 1 |