Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Atuveciclib, BAY1143572 · 1 trial · 1 indication
The MTD was defined as the highest dose that could be given such that not more than 20% of subjects experience a dose limiting toxicity (DLT) during Cycle 1. The study was terminated prior to the determination of MTD and hence no data was presented.
Maximum total observed drug concentration of BAY1143572 after single dose administration in plasma was measured.
Maximum total observed drug concentration of BAY1143572 after multiple dose administration in plasma was measured.
Area under the concentration versus time curve from zero to 24 hours of BAY1143572 in plasma after single dose administration was measured.
Area under the concentration versus time curve from zero to 24 hours of BAY1143572 in plasma after multiple dose administration was measured.
Area under the concentration versus time curve from zero to last data point greater than lower limit of quantitation of BAY1143572 in plasma after single dose administration was measured.
Time to reach maximum drug concentration of BAY1143572 in plasma after single dose administration was measured.
Time to reach maximum drug concentration of BAY1143572 in plasma after multiple dose administration was measured.
| Arm | Type | Description |
|---|---|---|
| 20 mg BAY1143572 | EXPERIMENTAL | Subjects received 20 milligram (mg) BAY1143572 tablet orally once daily from Cycle 1 Day 1 of each cycle. |
| 40 mg BAY1143572 | EXPERIMENTAL | Subjects received 40 mg BAY1143572 tablet orally once daily from Cycle 1 Day 1 of each cycle. |
| 80 mg BAY1143572 | EXPERIMENTAL | Subjects received BAY1143572 80 mg tablet orally once daily from Cycle 1 Day 1 of each cycle. |
| 120 mg BAY1143572 | EXPERIMENTAL | Subjects received BAY1143572 120 mg tablet orally once daily from Cycle 1 Day 1 of each cycle. |
| 160 mg BAY1143572 | EXPERIMENTAL | Subjects received BAY1143572 160 mg tablet orally once daily from Cycle 1 Day 1 of each cycle. |
| 200 mg BAY1143572 | EXPERIMENTAL | Subjects received BAY1143572 200 mg tablet orally once daily from Cycle 1 Day 1 of each cycle. |
| 240 mg BAY1143572 | EXPERIMENTAL | Subjects received BAY1143572 240 mg tablet orally once daily from Cycle 1 Day 1 of each cycle. |
| Name | Type | Description |
|---|---|---|
| Atuveciclib, BAY1143572 | DRUG | The starting dose was 20 mg BAY 1143572 once daily from Cycle 1 Day 1. Each cycle was defined as a period of 28 days. Dosing cycles continued until evidence of progression, unacceptable toxicity, consent withdrawal, or withdrawal from the study at the discretion of the investigator. |
Inclusion Criteria: * Male or female subjects aged \>/=18 years * Subjects with a histologically or cytologically confirmed acute leukemia who are refractory to or have exhausted all available therapies * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 * Life expectancy of at...
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Atuveciclib, also known as BAY1143572, is an investigational small molecule being studied for the treatment of leukemia. It is in Phase 1 clinical development for this oncology indication.
Atuveciclib is a small molecule developed by Bayer AG. Its specific molecular target has not been disclosed in available clinical trial information.
Atuveciclib is being developed by Bayer AG, a pharmaceutical company traded over the counter under the ticker BAYRY.
Atuveciclib is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities.
Atuveciclib has been studied in one completed Phase 1 clinical trial, NCT02345382, which was a dose escalation study in subjects with acute leukemia. The trial enrolled 42 participants and was conducted in the United States and Germany.
Yes, Atuveciclib is also known as BAY1143572. Both names refer to the same investigational drug being developed by Bayer AG for leukemia.