Therapy Detail
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| Therapy Name | Rigosertib Sodium |
| Synonyms | |
| Therapy Description |
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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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Rigosertib Sodium | ON 01910.Na|SyB L-1101 | PI3K Inhibitor (Pan) 42 PLK1 Inhibitor 18 | 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 |
|---|---|---|---|---|---|---|---|
| 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... |
| 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 |
| 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... |
| 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 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 |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT01928537 | Phase III | Rigosertib Sodium | Efficacy and Safety of IV Rigosertib in MDS Patients With Excess Blasts Progressing After Azacitidine or Decitabine | Completed | USA | SWE | ITA | FRA | ESP | DNK | DEU | AUS | 0 |
| NCT02107235 | Phase I | Cisplatin Rigosertib Sodium | Platinum-based Chemoradiotherapy and Rigosertib in Head and Neck Cancer | 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) | Terminated | USA | SWE | POL | ITA | ISR | IRL | HUN | HRV | GBR | FRA | EST | ESP | DEU | CZE | CHE | CAN | BEL | AUT | AUS | 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 |
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