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|Drug Name||Trade Name||Synonyms||Drug Classes||Drug Description|
|Rigosertib Sodium||ON 01910.Na|SyB L-1101||PI3K Inhibitor (Pan) 37 PLK1 Inhibitor 16||Rigosertib (ON 01910.Na) inhibits polo-like kinase 1 (Plk1) and PI3K pathways, which induces selective G2/M arrest and apoptosis in tumor cells (PMID: 24777753).|
|Molecular Profile||Indication/Tumor Type||Response Type||Therapy Name||Approval Status||Evidence Type||Efficacy Evidence||References|
|PIK3CA E545K||Advanced Solid Tumor||sensitive||Rigosertib Sodium||Preclinical - Cell culture||Actionable||In a preclinical study, Rigosertib (ON 01910.Na) inhibited oncogenic transformation in fibroblast cells over-expressing PIK3CA E545K in culture (PMID: 27104980).||27104980|
|PIK3CA H1047R||Advanced Solid Tumor||sensitive||Rigosertib Sodium||Preclinical - Cell culture||Actionable||In a preclinical study, Rigosertib (ON 01910.Na) inhibited oncogenic transformation in fibroblast cells over-expressing Pik3ca H1047R in culture (PMID: 27104980).||27104980|
|HRAS G12V||Advanced Solid Tumor||sensitive||Rigosertib Sodium||Preclinical - Cell culture||Actionable||In a preclinical study, Rigosertib (ON 01910.Na) inhibited oncogenic transformation in fibroblast cells over-expressing HRAS G12V in culture (PMID: 27104980).||27104980|
|Unknown unknown||Advanced Solid Tumor||not applicable||Rigosertib Sodium||Phase I||Actionable||In a Phase I study, Rigosertib (ON 01910.Na) demonstrated both safety and preliminary efficacy, resulted in a best overall response of stable disease in 41% (9/22) of patients with advanced solid tumors (PMID: 23841031; NCT01538537).||23841031|
|PIK3CA amp||head and neck squamous cell carcinoma||predicted - sensitive||Rigosertib Sodium||Case Reports/Case Series||Actionable||In a Phase I trial, Rigosertib (ON 01910.Na) treatment resulted in a complete response with disappearance of mediastinal and lung disease in a patients with head and neck squamous cell carcinoma harboring PIK3CA amplification (Cancer Res April 15 2013 (73) (8 Supplement) LB-198).||detail...|
|Unknown unknown||myelodysplastic syndrome||no benefit||Rigosertib Sodium||Phase III||Actionable||In a Phase III trial (ONTIME), Rigosertib (ON 01910.Na) did not improve median overall survival compared to best supportive care (8.2 vs 5.9 months, HR=0.87, p=0.33) in patients with myelodysplastic syndrome (PMID: 26968357; NCT01241500).||26968357|
|PIK3CA E545K||head and neck squamous cell carcinoma||sensitive||Rigosertib Sodium||Preclinical - Pdx||Actionable||In a preclinical study, head and neck squamous cell carcinoma patient-derived xenograft models harboring a PIK3CA E545K mutation demonstrated increased sensitivity to Rigosertib (ON 01910.Na) (PMID: 23873848).||23873848|
|Clinical Trial||Phase||Therapies||Title||Recruitment Status|
|NCT01928537||Phase III||Rigosertib Sodium||Efficacy and Safety of IV Rigosertib in MDS Patients With Excess Blasts Progressing After Azacitidine or Decitabine||Completed|
|NCT01584531||Phase II||Rigosertib Sodium||Efficacy and Safety of Oral Rigosertib in Transfusion-dependent, Low or Int-1 or Trisomy 8 Int-2 Myelodysplastic Syndrome||Completed|
|NCT02107235||Phase I||Cisplatin Rigosertib Sodium||Platinum-based Chemoradiotherapy and Rigosertib in Head and Neck Cancer||Completed|
|NCT02562443||Phase III||Rigosertib Sodium||Controlled Study of Rigosertib Versus Physician's Choice of Treatment in MDS Patients After Failure of an HMA (INSPIRE)||Active, not recruiting|