THERAPY DOSSIER · th-b639f2a9ac1c

Sorafenib (with or without chronic pretreatment with the Rho-kinase inhibitor fasudil)

Drug · Multikinase inhibitor: direct inhibition of RAF/BRAF, VEGFR, PDGFR-beta, KIT, FLT3 and RET. ATC L01EX02.

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Evidence & regulatory context

Mechanism: Multikinase inhibitor: direct inhibition of RAF/BRAF, VEGFR, PDGFR-beta, KIT, FLT3 and RET. ATC L01EX02.
Target: RAF1/BRAF; VEGFR; PDGFRB; KIT; FLT3; RET
Injury models: Ischaemia-reperfusion
Reported indication: Not recorded
First approval: 2005
Development stage: Not recorded
ChEMBL record: CHEMBL1336 ↗
ChEMBL max phase: 4 / 4 (development scale, not regulatory approval)
Synonyms: BAY 43-9006; Nexavar; Sorafenib tosylate; BAY 54-9085
Note: Not recorded

Clinical trials 10

0 linked trials carry an injury-indication flag. These flags support record-level exploration and sit alongside the stringent aggregate counts described in Methods.

NCT00494299 ↗PHASE3completed

Phase III Study of BAY43-9006 in Patients With Advanced Hepatocellular Carcinoma Treated After Transcatheter Arterial Chemoembolization

Carcinoma, Hepatocellular

Enrolment: 458 · Results not recorded

NCT01320111 ↗PHASE2completed

Paclitaxel Alone Versus Paclitaxel Plus Sorafenib in Second- or Third-line Treatment of Metastatic Breast Cancer

Metastatic Breast Cancer

Enrolment: 59 · Results not recorded

NCT00390611 ↗PHASE2completed

Paclitaxel/Carboplatin With or Without Sorafenib in First-Line Treatment of Stage III/IV Epithelial Ovarian Cancer

Ovarian Cancer

Enrolment: 85 · Results not recorded

NCT01444807 ↗PHASE2unknown

Sorafenib in Patients With Advanced Renal Cell Carcinoma After Radical Resection of Metastases

Metastatic Renal Cell Carcinoma

Enrolment: 132 · Results not recorded

NCT00096200 ↗PHASE2completed

BAY 43-9006 Plus Paclitaxel/Carboplatin in Recurrent Platinum Sensitive Epithelial Ovarian, Peritoneal or Fallopian Tube Cancer

Recurrent Ovarian Carcinoma · Recurrent Fallopian Tube Carcinoma

Enrolment: 44 · Results not recorded

NCT00390325 ↗PHASE2completed

Phase II Study of Sorafenib in Patients With Metastatic Medullary Thyroid Carcinoma

Thyroid Gland Medullary Carcinoma

Enrolment: 21 · Results not recorded

NCT01189370 ↗PHASE2completed

Efficacy and Tolerability of Dose Escalation of Sorafenib in Advanced Renal Cell Cancer

Renal Cell Cancer

Enrolment: 25 · Results not recorded

NCT01217034 ↗PHASE2unknown

Transcatheter Arterial Chemoembolization Therapy In Combination With Sorafenib (TACTICS)

Hepatocellular Carcinoma

Enrolment: 228 · Results not recorded

NCT02616692 ↗Phase not recordedcompleted

Patient Preferences for Treatments for Hepatocellular Cancer in Japan

Hepatocellular Cancer

Enrolment: 120 · Results not recorded

NCT01195649 ↗Phase not recordedterminated

Advanced Renal Cell Carcinoma With Failure or Unsuitable on Prior Interferon-alpha or Interleukin-2 Based Therapy

Carcinoma, Renal Cell

Enrolment: 11 · Results not recorded

Preclinical evidence 1

1 studies reported at therapy level; 1 evidence entries itemised.

PMID 22847887 ↗2012Reported benefit

Rho-kinase-dependent pathway mediates the hepatoprotective effects of sorafenib against ischemia/reperfusion liver injury in rats with nonalcoholic steatohepatitis.

RatIschaemia-reperfusionHepaticSprague-DawleyMaleAcute administration in the setting of ischaemia/reperfusion liver injury; fasu…

Model: Hepatic ischaemia/reperfusion injury in rats with nonalcoholic steatohepatitis

Acute sorafenib significantly attenuated hepatic inflammation, necrosis, apoptosis, leukocyte infiltration and microcirculatory dysfunction, with reduced macrophage inflammatory protein 2, keratinocyte chemoattractant and GM-CSF release, reduced caspase-3 and caspase-9 and DNA fragmentation, and de…

Extraction: extract · Subtype source: rule · Supplied extraction confidence: 0.6. Machine-extracted fields require source verification.

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