Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BAY86-9766 · 3 trials · 3 indications
| Arm | Type | Description |
|---|---|---|
| BAY86-9766 | EXPERIMENTAL | The study will be conducted in two parts and study treatments will be administered as follows: •Part A: Three subjects will be enrolled and will receive 10 mg of refametinib on Day 1. Once daily dosing of ketoconazole 400 mg will be initiated on Day 5 and will continue until Day 12 with 10 mg of refametinib administered concomitantly on Day 8 •Part B: Fifteen subjects will be enrolled and will receive refametinib doses of 10 mg, 20 mg or 30 mg on Days 1 and 8 with the same dose administered on both days. Refametinib dose for Part B will be based on safety and refametinib pharmacokinetics in Part A. Ketoconazole 400 mg will be administered once daily on Days 5 to 12. Subjects will stay in the investigational site for a total period of 15 consecutive days |
| Arm 1 | EXPERIMENTAL | - |
| Arm 2 | EXPERIMENTAL | - |
| Arm 3 | EXPERIMENTAL | - |
| Arm 4 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| BAY86-9766 | DRUG | - |
| Ketoconazole | DRUG | - |
| BAY86-9766+Gemcitabine | DRUG | Phase I: 40 mg/day (20 mg twice daily), 60 mg/day (30 mg twice daily, 100 mg/day (50 mg bid) dependent on safety/tolerability Phase II: Recommended Phase II dose (RP2D) dependent on the results of the Phase I part of this study Route of administration: Oral, twice daily (bid) in combination with gemcitabine 1000 mg/m2 Intravenous infusion over 30 minutes weekly for seven out of eight weeks (Cycle 1); followed by 1000 mg/m2 Intravenous infusion over 30 minutes weekly for three out of four weeks (Cycle 2 and subsequent) |
Inclusion Criteria: * Healthy male subject * Age: 18 to 45 years (inclusive) at the first screening examination / visit * Body mass index (BMI): 18.5 to 32 kg/m² (inclusive) * Ability to understand and follow study-related instructions. Subject, who is a sexually active man and has not been surgica...
BAY86-9766 is an investigational small molecule developed by Bayer AG. It has been studied in Phase 1 clinical trials for drug interactions, neoplasms, and pancreatic neoplasms, including a combination study with gemcitabine in advanced pancreatic cancer. It is not approved and remains in clinical development.
BAY86-9766 has been studied in a Phase 1 trial in combination with gemcitabine for advanced pancreatic cancer. This completed study enrolled 90 patients across the United States, Belgium, Czechia, France, Germany, Italy, Norway, Poland, and the United Kingdom. It is investigational and not approved for any use.
BAY86-9766 is developed by Bayer AG, which trades on the OTC market under the ticker BAYRY. Bayer sponsored the Phase 1 trials of the compound, including studies in pancreatic cancer, Japanese monotherapy, and a drug interaction study with ketoconazole.
BAY86-9766 is in Phase 1 clinical development. All three completed trials were Phase 1 studies, and no later-phase trials are listed. The drug is investigational and has not been approved by the FDA or any other regulatory agency for commercial use.
BAY86-9766 has been evaluated in three completed Phase 1 trials: NCT01925638, a drug interaction study with ketoconazole in healthy male volunteers; NCT01251640, a combination with gemcitabine in advanced pancreatic cancer; and NCT01179295, a Japanese monotherapy study in neoplasms.