Therapy Detail

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Therapy Name Rigosertib Sodium
Synonyms
Therapy Description

Estybon (rigosertib) inhibits polo-like kinase 1 (Plk1) and PI3K pathways, which induces selective G2/M arrest and apoptosis in tumor cells (PMID: 24777753).

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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).

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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

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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


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