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SPI-2012
SPI-2012 is a selective inhibitor of polo-like kinase 1 (PLK1) that disrupts cell cycle progression and induces apoptosis in cancer cells.
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.
At a glance
| Generic name | SPI-2012 |
|---|---|
| Also known as | Rolontis®, Eflapegrastim, (HM10460A), Rolontis™, HM10460A |
| Sponsor | Spectrum Pharmaceuticals, Inc |
| Drug class | PLK1 inhibitor |
| Target | PLK1 (Polo-like kinase 1) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | Phase 3 |
Mechanism of action
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.
Approved indications
- Advanced or metastatic solid tumors
- Non-Hodgkin's lymphoma
Common side effects
- Neutropenia
- Thrombocytopenia
- Anemia
- Nausea
- Fatigue
Key clinical trials
- A Study to Evaluate the Safety and Pharmacokinetics of Eflapegrastim in Pediatric Participants With Solid Tumors or Lymphomas and Treated With Myelosuppressive Chemotherapy (PHASE2)
- Reducing Neutropenia Incidence With Pegfilgrastim Administration on Day 3 After Chemotherapy (PHASE4)
- Phase 2 Study of SPI-2012 or Pegfilgrastim for the Management of Neutropenia in Participants With Breast Cancer (PHASE2)
- SPI-2012 vs Pegfilgrastim in Management of Neutropenia in Breast Cancer Participants With Docetaxel and Cyclophosphamide (PHASE3)
- SPI-2012 vs Pegfilgrastim in the Management of Neutropenia in Participants With Breast Cancer With Docetaxel and Cyclophosphamide (ADVANCE) (PHASE3)
- Pharmacokinetics of SPI-2012 (Eflapegrastim) in Breast Cancer Patients Receiving Docetaxel and Cyclophosphamide (TC) Chemotherapy (PHASE1)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- SPI-2012 CI brief — competitive landscape report
- SPI-2012 updates RSS · CI watch RSS
- Spectrum Pharmaceuticals, Inc portfolio CI