A Phase 1 interventional study of Atuveciclib, BAY1143572 in Leukemia, sponsored by Bayer. Completed at 7 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-06-25.
Sponsored by Bayer · Phase 1, Interventional, and Treatment
To determine the safety, tolerability, pharmacokinetics, maximum tolerated dose, and recommended Phase II dose of BAY1143572 in a once-daily or an intermittent dosing schedule in subjects with advanced acute leukemia
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's enrollment of 42 is above the median of 38 across 4,247 interventional studies indexed under Leukemia.
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Adequate liver and renal functions as assessed by the following laboratory requirements to be conducted within 14 days before the first dose of study drug:
Exclusion Criteria:
Subjects received 20 milligram (mg) BAY1143572 tablet orally once daily from Cycle 1 Day 1 of each cycle.
Drug: Atuveciclib, BAY1143572
Subjects received 40 mg BAY1143572 tablet orally once daily from Cycle 1 Day 1 of each cycle.
Drug: Atuveciclib, BAY1143572
Subjects received BAY1143572 80 mg tablet orally once daily from Cycle 1 Day 1 of each cycle.
Drug: Atuveciclib, BAY1143572
Subjects received BAY1143572 120 mg tablet orally once daily from Cycle 1 Day 1 of each cycle.
Drug: Atuveciclib, BAY1143572
Subjects received BAY1143572 160 mg tablet orally once daily from Cycle 1 Day 1 of each cycle.
Drug: Atuveciclib, BAY1143572
Subjects received BAY1143572 200 mg tablet orally once daily from Cycle 1 Day 1 of each cycle.
Drug: Atuveciclib, BAY1143572
Subjects received BAY1143572 240 mg tablet orally once daily from Cycle 1 Day 1 of each cycle.
Drug: Atuveciclib, BAY1143572
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.
Maximum Tolerated Dose (MTD) of BAY1143572 in Advanced Acute Leukemia Subjects
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.
Time frame: After the first 28 days of treatment (cycle 1)
Maximum Total Observed Drug Concentration (Cmax) of BAY1143572 after Single Dose Administration in Plasma
Maximum total observed drug concentration of BAY1143572 after single dose administration in plasma was measured.
Time frame: Pre-dose up to 24 hours post-dose on Cycle1 Day 1
Maximum Total Observed Drug Concentration of BAY1143572 after Multiple Dose Administration in Plasma (Cmax,md)
Maximum total observed drug concentration of BAY1143572 after multiple dose administration in plasma was measured.
Time frame: Pre-dose up to 24 hours post-dose on Cycle 1 Day 15
Area Under the Concentration Versus Time Curve from Zero to 24 hours (AUC[0-24h]) of BAY1143572 in Plasma After Single Dose Administration
Area under the concentration versus time curve from zero to 24 hours of BAY1143572 in plasma after single dose administration was measured.
Time frame: Pre-dose up to 24 hours post-dose on Cycle1 Day 1
Area Under the Concentration Versus Time Curve from Zero to 24 hours of BAY1143572 in Plasma after Multiple Dose Administration (AUC[O-24h]md)
Area under the concentration versus time curve from zero to 24 hours of BAY1143572 in plasma after multiple dose administration was measured.
Time frame: Pre-dose up to 24 hours post-dose on Cycle 1 Day 15
Area Under the Concentration Versus Time Curve from Zero to Last Data Point Greater than Lower Limit of Quantitation (LLOQ) of BAY1143572 in Plasma (AUC[0-tlast]) after Single Dose Administration
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 frame: Pre-dose up to 24 hours post-dose on Cycle 1 Day 1
Time to Reach Maximum Drug Concentration (tmax) of BAY1143572 in Plasma after Single Dose Administration
Time to reach maximum drug concentration of BAY1143572 in plasma after single dose administration was measured.
Time frame: pre-dose up to 24 hours post-dose on Cycle 1 Day 1
Time to Reach Maximum Drug Concentration of BAY1143572 in Plasma after Multiple Dose Administration (tmax,md)
Time to reach maximum drug concentration of BAY1143572 in plasma after multiple dose administration was measured.
Time frame: Pre-dose up to 24 hours post-dose on Cycle 1 Day 15
Number of Subjects With Leukemia Response
Bone marrow aspirates / biopsies / peripheral whole blood were taken and assessed for leukemia response evaluation. Assessment of response was made based on the revised recommendations of the International Working Group (Cheson 2003 criteria). Criteria proposed by Cheson 2003 for leukemia: complete remission (CR), morphological CR with incomplete blood count recovery (CRi), partial remission (PR), no response / treatment failure, relapse from CR, CRi, or PR.
Time frame: From start of treatment of the first subject until 28 days
Number of Subjects with Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
An adverse event (AE) was any untoward medical occurrence in subject who received study drug without regard to possibility of causal relationship. AEs that started or worsened after first administration of study medication up to 30 days after end of treatment with study medication were considered to be treatment emergent (TE). A serious adverse event (SAE) was an AE resulting in any of following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly and another medical important serious event as judged by investigator. SAEs that started or worsened after study drug treatment were recorded as TESAEs.
Time frame: From start of study drug administration up to 30 days after the last dose of study drug administration (approximately 2.5 years)
Area Under the Concentration Versus Time Curve from Zero to Infinity (AUC) of BAY1143572 after Single Dose Administration in Plasma
Area under the concentration versus time curve from zero to infinity of BAY1143572 after single dose administration in plasma was measured.
Time frame: Pre-dose up to 24 hours post-dose on C1D1
This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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