Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BAY1217389 · 1 trial · 1 indication
The MTD is defined as the highest dose that can be given such that the dose-limiting toxicity (DLT) rate of the combination treatment is not more than 10% higher than the cumulative DLT rate of the standard single-agent treatment across all previous and the current cohort.
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | Experimental Treatment (combination of BAY1217389 with paclitaxel in an intermittent dosing schedule) Expansion Cohort - Maximum tolerated dose of BAY1217389 and Paclitaxel |
| Arm 2 | PLACEBO_COMPARATOR | Standard Treatment (Single-agent Paclitaxel ) |
| Name | Type | Description |
|---|---|---|
| BAY1217389 | DRUG | BAY1217389 will be given orally, with a starting dose of 0.25 mg twice daily, on D1, D2, D8, D9, D15 and D16 of a 28 day cycle. BAY1217389 will be dosed in combination with paclitaxel in Arm 1 (Experimental Treatment) and from Cycle 2 onwards in Arm 2 (Standard Treatment). After Maximum tolerated dose (MTD) has been defined, expansion cohorts will be conducted at the MTD dose of BAY1217389 and paclitaxel following an intermittent dosing schedule as defined in the dose escalation phase. Up to 12 to 15 breast cancer (triple negative) subjects are planned to be enrolled in the expansion cohort. In a higher dose level Cohort 4 \> (or equal to) a relative bioavailability assessment of BAY1217389 liquid capsule formulation compared to BAY1217389 oral solution will be performed. |
| Paclitaxel | DRUG | Paclitaxel will be given once per week IV at 90 mg/m\^2 on D1, D8, and D15 of a 28 day cycle. Paclitaxel will be dosed as a single-agent in Cycle 1 of Arm 2 (Standard Treatment Arm), and in combination with BAY1217389 in Arm 1 (Experimental Treatment Arm) and from Cycle 2 onwards in Arm 2 (Standard Treatment Arm). After Maximum tolerated dose (MTD) has been defined, expansion cohorts will be conducted at the MTD dose of BAY1217389 and paclitaxel following an intermittent dosing schedule as defined in the dose escalation phase. Up to 12 to 15 breast cancer (triple negative) subjects are planned to be enrolled in the expansion cohort. |
Inclusion Criteria: * Male or female subjects aged \>/= 18 years. * Study population: * For the dose-escalation cohorts: Subjects with histologically or cytologically confirmed advanced malignancies (solid tumors), refractory to any standard therapy, have no standard therapy available * For th...
BAY1217389 is an investigational small molecule being developed by Bayer AG for medical oncology. It is currently in Phase 1 clinical development. The drug is being studied in combination with intravenous paclitaxel for the treatment of cancer. As of now, it remains investigational and has not been approved by regulatory authorities.
The specific molecular target of BAY1217389 has not been disclosed in available information. It is being studied as a potential cancer treatment in combination with paclitaxel. The drug's mechanism of action is not publicly detailed in the current clinical trial data.
BAY1217389 is being developed by Bayer AG, a multinational pharmaceutical company. Bayer's stock is traded under the ticker symbol BAYRY on the over-the-counter market. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug in oncology.
BAY1217389 is in Phase 1 clinical development. A Phase 1 study of the drug in combination with intravenous paclitaxel has been completed. The drug is still in the investigational stage and has not received regulatory approval for any indication.
BAY1217389 has been studied in one clinical trial with the identifier NCT02366949. This was a Phase 1 study of oral BAY 1217389 in combination with intravenous paclitaxel, conducted in the United States and Netherlands. The trial enrolled 75 participants and has been completed.
Yes, BAY1217389 and BAY 1217389 refer to the same investigational drug. The clinical trial record for the Phase 1 study uses the name 'BAY 1217389' with a space, while the drug is commonly referred to as BAY1217389 without a space. Both names identify the same compound.