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Therapy Name | Trifluridine-tipiracil hydrochloride |
Synonyms | |
Therapy Description |
Lonsurf (trifluridine/tipiracil hydrochloride) is an oral combination comprised of TFT and a thymidine phosphorylase inhibitor, which can result in DNA fragmentation thereby preventing angiogenesis and tumor growth (NCI Drug Dictionary). Lonsurf (TAS-102) is FDA approved for use in patients with colorectal cancer, gastric or gastroesophageal junction adenocarcinoma (FDA.gov). |
Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
---|---|---|---|---|
Trifluridine-tipiracil hydrochloride | Lonsurf | TAS-102|TAS102|TAS 102|S 95005|S95005|S-95005 | Lonsurf (trifluridine/tipiracil hydrochloride) is an oral combination comprised of TFT and a thymidine phosphorylase inhibitor, which can result in DNA fragmentation thereby preventing angiogenesis and tumor growth and is FDA approved for use in patients with colorectal cancer, gastric or gastroesophageal junction adenocarcinoma (FDA.gov). |
Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
---|---|---|---|---|---|---|---|
Unknown unknown | stomach cancer | not applicable | Trifluridine-tipiracil hydrochloride | Phase III | Actionable | In a Phase III trial (TAGS) that supproted FDA approval, Lonsurf (trifluridine/tipiracil hydrochloride) treatment resulted in improved overall survival (5.7 vs 3.6 months, HR=0.69, p=0.00029) compared to placebo in patients with heavily pretreated metastatic or advanced gastric cancer or gastroesophageal junction adenocarcinoma (PMID: 30355453; NCT02500043). | 30355453 detail... |
Unknown unknown | colorectal cancer | not applicable | Trifluridine-tipiracil hydrochloride | FDA approved | Actionable | In a Phase III trial supporting FDA approval, Lonsurf (trifluridine/tipiracil hydrochloride) demonstrated improved median overall survival (7.1 vs 5.3 months), median progression free survival (2.0 vs 1.7 months), and 32% reduction of death risk compared to placebo in treatment-refractory metastatic colorectal cancer patients (PMID: 27126991). | 27126991 detail... |
Unknown unknown | gastroesophageal junction adenocarcinoma | not applicable | Trifluridine-tipiracil hydrochloride | FDA approved | Actionable | In a Phase III trial (TAGS) that supproted FDA approval, Lonsurf (trifluridine/tipiracil hydrochloride) treatment resulted in improved overall survival (5.7 vs 3.6 months, HR=0.69, p=0.00029) compared to placebo in patients with heavily pretreated metastatic or advanced gastric cancer or gastroesophageal junction adenocarcinoma (PMID: 30355453; NCT02500043). | detail... 30355453 |
Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
---|---|---|---|---|---|---|
NCT01916447 | Phase I | Bevacizumab Trifluridine-tipiracil hydrochloride Irinotecan | A Phase I Study of TAS-102 in Patients With Advanced Gastrointestinal Tumors. | Completed | USA | 0 |
NCT02301117 | Phase I | Trifluridine-tipiracil hydrochloride | A Phase I Study of TAS-102 in Patients With Advanced Solid Tumors With Renal Impairment | Active, not recruiting | USA | 2 |
NCT04042714 | Phase II | Trifluridine-tipiracil hydrochloride | TAS-102 in Extrapulmonary Neuroendocrine Carcinoma (TAS-102 NEC) | Recruiting | USA | 0 |
NCT03992456 | Phase II | Panitumumab Regorafenib Trifluridine-tipiracil hydrochloride | Panitumumab, Regorafenib, or TAS-102, in Treating Patients With Metastatic and/or Unresectable RAS Wild-Type Colorectal Cancer | Recruiting | USA | 0 |
NCT04073615 | Phase Ib/II | Rivoceranib + Trifluridine-tipiracil hydrochloride Rivoceranib Trifluridine-tipiracil hydrochloride | Phase 1b/2 Study of Rivoceranib and Trifluridine/Tipiracil for Metastatic Colorectal Cancer | Recruiting | USA | 0 |
NCT03981614 | Phase II | Trifluridine-tipiracil hydrochloride Binimetinib + Palbociclib | Binimetinib and Palbociclib or TAS-102 in Treating Patients With KRAS and NRAS Mutant Metastatic or Unresectable Colorectal Cancer | Recruiting | USA | 0 |
NCT02500043 | Phase III | Trifluridine-tipiracil hydrochloride | Study of TAS-102 or Placebo Plus BSC in Patients With Metastatic Gastric Cancer | Completed | USA | CAN | 16 |
NCT03762161 | Phase II | Trifluridine-tipiracil hydrochloride | A Phase II Study of Lonsurf (TAS-102) in Metastatic Platinum and Checkpoint Inhibitor-resistant Bladder Cancer | Recruiting | USA | 0 |
NCT04737187 | Phase III | Bevacizumab + Trifluridine-tipiracil hydrochloride Trifluridine-tipiracil hydrochloride | Phase III Study of Trifluridine/Tipiracil in Combination With Bevacizumab vs Trifluridine/Tipiracil Single Agent in Patients With Refractory Metastatic Colorectal Cancer (SUNLIGHT) | Recruiting | USA | 1 |
NCT02602327 | Phase I | Trifluridine-tipiracil hydrochloride | Tas-102 and Radioembolization With 90Y Resin Microspheres for Chemo-refractory Colorectal Liver Metastases | Active, not recruiting | USA | 0 |
NCT03844620 | Phase II | Regorafenib Trifluridine-tipiracil hydrochloride Regorafenib + Trifluridine-tipiracil hydrochloride | Circulating Cell-Free Tumor DNA Testing in Guiding Treatment for Patients With Advanced or Metastatic Colorectal Cancer | Recruiting | USA | 0 |