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) 39 PLK1 Inhibitor 17 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
PTEN loss 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 partial response with 53% decrease of liver metastasis in a patients with head and neck squamous cell carcinoma harboring PTEN loss (Cancer Res April 15 2013 (73) (8 Supplement) LB-198). detail...
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
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
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...
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 Covered Countries Other Countries
NCT02107235 Phase I Cisplatin Rigosertib Sodium Platinum-based Chemoradiotherapy and Rigosertib in Head and Neck Cancer Completed USA 0
NCT01928537 Phase III Rigosertib Sodium Efficacy and Safety of IV Rigosertib in MDS Patients With Excess Blasts Progressing After Azacitidine or Decitabine Completed USA | ITA | FRA | ESP | DEU 3
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 USA 0
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 USA | ITA | FRA | ESP | DEU | CAN | BEL | AUT 14


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