Therapy Detail

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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).

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Drug Name Trade Name Synonyms Drug Classes Drug Description
trifluridine/tipiracil hydrochloride Lonsurf TAS-102 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).

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
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
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...

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Clinical Trial Phase Therapies Title Recruitment Status
NCT03762161 Phase II trifluridine/tipiracil hydrochloride A Phase II Study of Lonsurf (TAS-102) in Metastatic Platinum and Checkpoint Inhibitor-resistant Bladder Cancer Recruiting
NCT04042714 Phase II trifluridine/tipiracil hydrochloride TAS-102 in Extrapulmonary Neuroendocrine Carcinoma (TAS-102 NEC) Recruiting
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
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
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
NCT01916447 Phase I Bevacizumab trifluridine/tipiracil hydrochloride Irinotecan A Phase I Study of TAS-102 in Patients With Advanced Gastrointestinal Tumors. Completed
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
NCT02602327 Phase I trifluridine/tipiracil hydrochloride Tas-102 and Radioembolization With 90Y Resin Microspheres for Chemo-refractory Colorectal Liver Metastases Recruiting
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
NCT02500043 Phase III trifluridine/tipiracil hydrochloride Study of TAS-102 or Placebo Plus BSC in Patients With Metastatic Gastric Cancer Completed


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