{"id":"spi-2012","safety":{"commonSideEffects":[{"rate":null,"effect":"Neutropenia"},{"rate":null,"effect":"Thrombocytopenia"},{"rate":null,"effect":"Anemia"},{"rate":null,"effect":"Nausea"},{"rate":null,"effect":"Fatigue"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"anthropic-haiku","explanation":"PLK1 is a serine/threonine kinase essential for mitotic progression and cell cycle checkpoint control. By inhibiting PLK1, SPI-2012 prevents proper mitotic spindle formation and cytokinesis, leading to mitotic arrest and apoptosis in rapidly dividing cancer cells. This mechanism is particularly effective in tumors with dysregulated cell cycle control.","oneSentence":"SPI-2012 is a selective inhibitor of polo-like kinase 1 (PLK1) that disrupts cell cycle progression and induces apoptosis in cancer cells.","_ai_confidence":"medium"},"_scrapedAt":"2026-03-28T01:35:52.674Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"Advanced or metastatic solid tumors"},{"name":"Non-Hodgkin's lymphoma"}]},"trialDetails":[{"nctId":"NCT04570423","phase":"PHASE2","title":"A Study to Evaluate the Safety and Pharmacokinetics of Eflapegrastim in Pediatric Participants With Solid Tumors or Lymphomas and Treated With Myelosuppressive Chemotherapy","status":"RECRUITING","sponsor":"Spectrum Pharmaceuticals, Inc","startDate":"2021-05-20","conditions":"Solid Tumors, Lymphoma","enrollment":40},{"nctId":"NCT05949333","phase":"PHASE4","title":"Reducing Neutropenia Incidence With Pegfilgrastim Administration on Day 3 After Chemotherapy","status":"UNKNOWN","sponsor":"Eunseong Medical Foundation Good GANG-AN HOSPITAL","startDate":"2023-11-07","conditions":"Breast Neoplasms","enrollment":100},{"nctId":"NCT01724866","phase":"PHASE2","title":"Phase 2 Study of SPI-2012 or Pegfilgrastim for the Management of Neutropenia in Participants With Breast Cancer","status":"COMPLETED","sponsor":"Spectrum Pharmaceuticals, Inc","startDate":"2013-03-25","conditions":"Neutropenia","enrollment":148},{"nctId":"NCT02953340","phase":"PHASE3","title":"SPI-2012 vs Pegfilgrastim in Management of Neutropenia in Breast Cancer Participants With Docetaxel and Cyclophosphamide","status":"COMPLETED","sponsor":"Spectrum Pharmaceuticals, Inc","startDate":"2017-05-10","conditions":"Neutropenia, Breast Cancer","enrollment":237},{"nctId":"NCT02643420","phase":"PHASE3","title":"SPI-2012 vs Pegfilgrastim in the Management of Neutropenia in Participants With Breast Cancer With Docetaxel and Cyclophosphamide (ADVANCE)","status":"COMPLETED","sponsor":"Spectrum Pharmaceuticals, Inc","startDate":"2016-01-19","conditions":"Neutropenia, Breast Cancer","enrollment":406},{"nctId":"NCT03135951","phase":"PHASE1","title":"Pharmacokinetics of SPI-2012 (Eflapegrastim) in Breast Cancer Patients Receiving Docetaxel and Cyclophosphamide (TC) Chemotherapy","status":"COMPLETED","sponsor":"Spectrum Pharmaceuticals, Inc","startDate":"2017-05-11","conditions":"Breast Cancer, Pharmacokinetics","enrollment":26}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Rolontis®","Eflapegrastim","(HM10460A)","Rolontis™","HM10460A"],"phase":"phase_3","status":"active","brandName":"SPI-2012","genericName":"SPI-2012","companyName":"Spectrum Pharmaceuticals, Inc","companyId":"spectrum-pharmaceuticals-inc","modality":"Small molecule","firstApprovalDate":"","aiSummary":"SPI-2012 is a selective inhibitor of polo-like kinase 1 (PLK1) that disrupts cell cycle progression and induces apoptosis in cancer cells. Used for Advanced or metastatic solid tumors, Non-Hodgkin's lymphoma.","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":4,"withResults":3},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}