Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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 being studied for the treatment of hepatocellular carcinoma and solid cancer. It is in Phase 2 clinical development and is not approved by the FDA. The drug is being evaluated in patients with these conditions.
BAY73-4506 is being developed by Bayer AG, a pharmaceutical company traded under the ticker BAYRY. The drug is currently in Phase 2 clinical trials for hepatocellular carcinoma and solid cancer.
BAY73-4506 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials are ongoing to evaluate its safety and efficacy in patients with hepatocellular carcinoma and solid cancer.
BAY73-4506 has been studied in two completed Phase 2 trials. NCT01003015 enrolled 36 patients with hepatocellular carcinoma across Germany, Italy, South Korea, and Spain. NCT03890731 enrolled 6 patients with solid cancer in the United States, Germany, Italy, Japan, and the United Kingdom.
BAY73-4506 is also known as regorafenib. The drug is being developed by Bayer AG and is in Phase 2 clinical trials for hepatocellular carcinoma and solid cancer. It is an investigational small molecule and has not been approved by the FDA.