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BAY73-4506 · 2 trials · 2 indications
An AE was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An SAE was defined as any untoward medical occurrence that, at any dose: 1. results in death 2. is life-threatening 3. requires inpatient hospitalization or prolongation of existing hospitalization, etc.
AEs were categorized by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
A drug-related adverse event was any AE judged by investigator as having a reasonable suspected causal relationship to study drug.
A drug-related adverse event was any AE judged by investigator as having a reasonable suspected causal relationship to study drug. AEs were categorized by Common Terminology Criteria for Adverse Events (CTCAE) v5.0
| Arm | Type | Description |
|---|---|---|
| Adult patients | OTHER | Adult patients from completed Bayer-sponsored regorafenib trials who are benefitting from regorafenib treatment. |
| Arm 1 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| BAY73-4506 (Regorafenib, Stivarga) | DRUG | Regorafenib is administered orally as 20 or 40 mg tablets at the dose that each patient received during the last cycle of the feeder trial. The dose may be either 60, 80, 120 or 160 mg once daily for 3 weeks of every 4-week cycle (3 weeks on, 1 week off). |
| BAY73-4506 | DRUG | 160 mg BAY73-4506 |
Inclusion Criteria: * Participant must be age-eligible in the feeder study at the time of signing the informed consent. * Participant is currently participating in any Bayer-sponsored regorafenib study and is receiving study treatment. * Participant is currently benefiting from treatment with regor...
BAY73-4506 is an investigational small molecule oncology drug also known as regorafenib, or by the brand name Stivarga. It is being studied in hepatocellular carcinoma and solid cancers. Bayer AG, which trades under the ticker BAYRY, is the developer. The compound is a small molecule modality being evaluated in Phase 2 clinical development.
BAY73-4506, also called regorafenib, is being studied for the treatment of hepatocellular carcinoma, a form of liver cancer. It is also being evaluated in solid cancers more broadly. These uses remain investigational, and the drug is in Phase 2 clinical development rather than approved for these indications.
Bayer AG develops BAY73-4506, which is also known as regorafenib or Stivarga. Bayer is a German pharmaceutical and life sciences company whose shares trade over the counter in the United States under the ticker BAYRY. The company sponsors the clinical studies evaluating the drug in hepatocellular carcinoma and solid cancers.
BAY73-4506, also known as regorafenib, is in Phase 2 clinical development. It is an investigational small molecule and is not described as approved for the hepatocellular carcinoma and solid cancer indications being studied. The Phase 2 program includes completed studies, with no active trials currently listed.
Two completed Phase 2 trials are registered for BAY73-4506. NCT01003015 was a safety study in patients with hepatocellular carcinoma that enrolled 36 participants across Germany, Italy, South Korea, and Spain. NCT03890731 studied regorafenib in participants previously treated in completed Bayer-sponsored regorafenib studies, enrolling 6 patients with solid cancer across the United States, Germany, Italy, Japan, and the United Kingdom.
Yes. BAY73-4506 is the same compound as regorafenib, which is also marketed under the brand name Stivarga. The three names refer to the same small molecule developed by Bayer AG. Readers searching for regorafenib or Stivarga are looking at the same drug asset described here as BAY73-4506.