Floatz Rating
B61/100
Confidence
Indicative
Sponsor
The First Affiliated Hospital of Soochow University
Modality
Small molecule
Development Phase
Phase 3
Status
Active
Evidence ledger · v0.2
Clinical Evidence
Clinical track record: trial progression, reported outcomes, safety signals, and endpoint quality.
62High confidence
Detailed axis rationale is planned and will be published soon.
| Trial | Phase | Status | N | Primary endpoint | Readout |
|---|---|---|---|---|---|
NCT07463651CT.gov MRD-guided Maintenance Post-HCT: Gilteritini vs Sorafenib | — | Recruiting | — | — | — |
NCT07572695CT.gov Salvage Haploidentical HSCT With DLI and Targeted Therapy for R/R AML | — | Not Yet Recruiting | — | — | — |
NCT07264010CT.gov Sorafenib Combined With Venetoclax as Pre-emptive Therapy Strategy for MRD+ AML: a Prospective, Single-arm, Multicenter Clinical Study | — | Not Yet Recruiting | — | — | — |
NCT06532084CT.gov Sorafenib Relapase Prophylaxis After HCT With PTBCy Regimen | — | Recruiting | — | — | — |
NCT06221683CT.gov Clinical Study of Induction Therapy Options Based on Molecular Subtyping and MRD in Children and Adolescents With AML | — | Recruiting | — | — | — |
NCT03878524CT.gov Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial | — | Terminated | — | — | — |
NCT04326439CT.gov AflacLL1901 (CHOA-AML) | — | Terminated | — | — | — |
NCT03247088CT.gov Sorafenib, Busulfan and Fludarabine in Treating Patients With Recurrent or Refractory Acute Myeloid Leukemia Undergoing Donor Stem Cell Transplant | — | Active Not Recruiting | — | — | — |
NCT03132454CT.gov Palbociclib and Sorafenib, Decitabine, or Dexamethasone in Treating Patients With Recurrent or Refractory Leukemia | — | Active Not Recruiting | — | — | — |
NCT03170895CT.gov Combination of Sorafenib and Omacetaxine Mepesuccinate in Newly Diagnosed or Relapsed/Refractory AML Carrying FLT3-ITD | — | Completed | — | — | — |
Show 23 more trialsShow fewer
NCT03164057CT.gov A Trial of Epigenetic Priming in Patients With Newly Diagnosed Acute Myeloid Leukemia | — | Active Not Recruiting | — | — | — |
NCT02728050CT.gov Filgrastim, Cladribine, Cytarabine, and Mitoxantrone With Sorafenib in Treating Patients With Newly-Diagnosed, Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndrome | — | Completed | — | — | — |
NCT02779283CT.gov Personalized Kinase Inhibitor Therapy Combined With Chemotherapy in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia and Acute Lymphoblastic Leukemia | — | Completed | — | — | — |
NCT02530476CT.gov Phase I/II, Study of Selective Inhibitor of Nuclear Export (SINE) Selinexor (KPT-330) + Sorafenib in Acute Myeloid Leukemia | — | Completed | — | — | — |
NCT02474290CT.gov Sorafenib for Prophylaxis of Leukemia Relapse in Allo-HSCT Recipients With FLT3-ITD Positive AML | — | Completed | — | — | — |
NCT02270788CT.gov Crenolanib in Combination With Sorafenib in Patients With Refractory or Relapsed Hematologic Malignancies | — | Completed | — | — | — |
NCT02412475CT.gov Epigenetic Reprogramming in Relapse AML | — | Terminated | — | — | — |
NCT01861314CT.gov Bortezomib, Sorafenib Tosylate, and Decitabine in Treating Patients With Acute Myeloid Leukemia | — | Active Not Recruiting | — | — | — |
NCT01620216CT.gov Targeted Therapy in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia or Acute Myelogenous Leukemia | — | Terminated | — | — | — |
NCT01534260CT.gov Phase I/II Study of Combination of Sorafenib, Vorinostat, and Bortezomib for the Treatment of Acute Myeloid Leukemia With Complex- or Poor-risk (Monosomy 5/7) Cytogenetics or FLT3-ITD Positive Genotype | — | Completed | — | — | — |
NCT04788420CT.gov Influence of Co-existing Mutations on Sorafenib Maintenance Therapy After Allo-HSCT for Patients With FLT3-ITD AML | — | Completed | — | — | — |
NCT01398501CT.gov Sorafenib Maintenance Therapy for Patients With AML After Allogeneic Stem Cell Transplant | — | Completed | — | — | — |
NCT01371981CT.gov Bortezomib and Sorafenib Tosylate in Treating Patients With Newly Diagnosed Acute Myeloid Leukemia | — | Completed | — | — | — |
NCT03622541CT.gov Using Sorafenib as a Salvage Treatment for Relapsed or Refractory Acute Myeloid Leukemia Carrying FLT3-ITD | — | Completed | — | — | — |
NCT00943943CT.gov Granulocyte-colony Stimulating Factor (G-CSF) and Plerixafor Plus Sorafenib for Acute Myelogenous Leukemia (AML) With FLT3 Mutations | — | Completed | — | — | — |
NCT01159301CT.gov Entinostat and Sorafenib Tosylate in Treating Patients With Advanced or Metastatic Solid Tumors or Refractory or Relapsed Acute Myeloid Leukemia | — | Terminated | — | — | — |
NCT00908167CT.gov Sorafenib in Combination With Cytarabine and Clofarabine in Patients With Refractory or Relapsed Hematologic Malignancies | — | Completed | — | — | — |
NCT00875745CT.gov Combination of Sorafenib and Vorinostat in Poor-risk Acute Myelogenous Leukemia (AML) and High Risk Myelodysplastic Syndrome (MDS) | — | Completed | — | — | — |
NCT00893373CT.gov Study Evaluating Sorafenib Added to Standard Primary Therapy in Patients With Newly Diagnosed Acute Myeloid Leukemia Less Than 60 Years of Age | — | Completed | — | — | — |
NCT00542971CT.gov Phase I-II Study of Idarubicin, Cytarabine, and Sorafenib (BAY43-9006) | — | Completed | — | — | — |
NCT00373373CT.gov Efficacy of Sorafenib Added to Standard Primary Therapy in Elderly Patients With Newly Diagnosed AML | — | Completed | — | — | — |
NCT00217646CT.gov Sorafenib in Treating Patients With Refractory or Relapsed Acute Leukemia, Myelodysplastic Syndromes, or Blastic Phase Chronic Myelogenous Leukemia | — | Completed | — | — | — |
NCT00131989CT.gov Sorafenib in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia, Acute Lymphoblastic Leukemia, or Chronic Myelogenous Leukemia | — | Completed | — | — | — |
Competitive Position
Competitive setting: how crowded the indication is, class-level failures, and timing against rivals.
59High confidence
Detailed axis rationale is planned and will be published soon.
Same indication · Acute Myeloid Leukemia
| Asset | Sponsor | Phase | Rating |
|---|---|---|---|
| Sorafenib (this asset) | The First Affiliated Hospital of Soochow University | P3 | B · 61 |
| Gemtuzumab | M.D. Anderson Cancer Center | P4 | A |
| Amsacrine | University Hospital, Toulouse | P4 | BBB |
| Posaconazole | AstraZeneca | P4 | BBB |
| (+)-Vincristine | Janssen Research & Development, LLC | P3 | BBB |
| Aclacinomycin | Chinese PLA General Hospital | P4 | BB |
| Alvocidib | M.D. Anderson Cancer Center | P2 | BB |
| Prednisone | Children's Oncology Group | P3 | BB |
| Therapeutic Allogeneic Lymphocytes | University of Southern California | P2 | BB |
+42 more in the Acute Myeloid Leukemia cohort
Other indications for Sorafenib
| Indication | Sponsor | Phase | Rating |
|---|---|---|---|
| Renal Cell Carcinoma | — | P4 | BBB · 79 |
| Portal Vein Thrombosis | — | P4 | BBB · 74 |
| Adult Hepatocellular Carcinoma | — | P3 | BBB · 73 |
Scientific Foundation
Strength of the underlying biology: target validation, tractability, modality fit, and how related mechanisms have fared.
NR
Planned for methodology v0.2.
Development Feasibility
How realistically the program can be executed, drawing on modality precedent, enrollment dynamics, and sponsor delivery.
NR
Planned for methodology v0.2.
Commercial Opportunity
Commercial prize: addressable population, unmet need, and the value case for the indication.
NR
Planned for methodology v0.2.
IP & Exclusivity
Exclusivity position, covering patent protection and freedom-to-operate runway.
NR
Planned for methodology v0.2.
Manufacturing & Supply
Manufacturing and supply readiness, driven by modality process and scale-up risk.
NR
Planned for methodology v0.2.
Related assets
Citation
Floatz Terminal. Sorafenib in Acute Myeloid Leukemia. Methodology v0.2. Rated under v0.2 effective July 8, 2026. Last refreshed July 8, 2026. Accessed July 14, 2026. https://terminal.floatz.ai/assets/sorafenib-acute-myeloid-leukemia
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