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Also known as Sorafenib
Nexavar · 8 trials · 9 indications
Disease recurrence of HCC (intra or extra hepatic) was defined as the appearance of a new intrahepatic lesions fulfilling the American Association for the Study of Liver Diseases (AASLD) criteria of diagnosis of HCC or a new extra-hepatic lesions according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria version 1.0. In addition to investigator assessment, all images were reviewed by an independent panel of radiologists. The calculation of the RFS was based on the independent evaluation of the scans. RFS was defined as the time from randomization to the first documented disease recurrence by independent radiological assessment or death due to any cause whichever occurred first. For subjects who had not recurred or died at the time of analysis, RFS was censored at their last date of evaluable scan before drop-out for any other reason than recurrence or death.
| Arm | Type | Description |
|---|---|---|
| Sorafenib (Nexavar, BAY43-9006) | EXPERIMENTAL | Participants received 2 tablets of Sorafenib (2×200 mg) orally twice daily (BID) |
| Placebo | PLACEBO_COMPARATOR | Participants received 2 tablets of placebo orally twice daily (BID) |
| Arm 1 | EXPERIMENTAL | - |
| Arm 2 | EXPERIMENTAL | - |
| Arm 3 | EXPERIMENTAL | - |
| Arm 4 | EXPERIMENTAL | - |
| Arm 5 | EXPERIMENTAL | - |
| Arm 6 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Nexavar (Sorafenib, BAY43-9006) | DRUG | Sorafenib 400 mg twice daily (BID) |
| Placebo | DRUG | Placebo 2 tablets twice daily (BID) |
| Bevacizumab | DRUG | Bevacizumab 2.5 mg/kg intravenously |
| Paclitaxel | DRUG | Paclitaxel 200 mg/m² intravenously |
| Carboplatin | DRUG | Carboplatin AUC 6 intravenously |
Inclusion Criteria: * Subjects who have undergone surgical resection or local ablation (PEI or percutaneous or intraoperative RFA) for treatment of HCC with curative intent within 4 months from staging to potentially curative treatment. A maximum of 2 local ablation courses may be administered duri...
Nexavar (sorafenib) is an investigational small molecule oncology drug being studied for use in hepatocellular carcinoma, renal cell carcinoma, chronic myelogenous leukemia, and non-small-cell lung cancer. It is a kinase inhibitor in the -nib class. Nexavar is not FDA approved and remains in clinical development.
Nexavar is a kinase inhibitor, belonging to the -nib class of drugs. It targets kinases involved in cancer cell signaling and tumor growth. The drug is being investigated for its activity against several cancer types, including hepatocellular carcinoma and renal cell carcinoma.
Nexavar is being developed by Bayer AG, a German pharmaceutical company traded on the OTC market under the ticker BAYRY. Bayer is conducting clinical trials of Nexavar across multiple oncology indications, including renal cell carcinoma and hepatocellular carcinoma.
Nexavar is in Phase 1 clinical development. While some completed trials were Phase 2 and Phase 3, the drug's current development stage is Phase 1. Nexavar is investigational and has not received FDA approval. It is being studied for several cancers, including renal cell carcinoma and hepatocellular carcinoma.
Nexavar has been studied in clinical trials including NCT00492986, a Phase 3 study in advanced renal cell carcinoma with 1,150 participants, and NCT00661375, a Phase 2 study in renal cell carcinoma with 131 participants. Additional trials include NCT00692770 in hepatocellular carcinoma and NCT01069328 in non-small-cell lung cancer.
Yes, Nexavar is the same as sorafenib. Sorafenib is the generic name for the drug, while Nexavar is the brand name. Both names refer to the same investigational kinase inhibitor being developed by Bayer AG for oncology indications.