An Open Phase I/IIa Trial to Investigate the Maximum Tolerated Dose, Safety, Pharmacokinetics, and Efficacy of Intravenous BI 6727 as Monotherapy or in Combination With Subcutaneous Cytarabine in Patients With Acute Myeloid Leukaemia

简要总结

主要结局

次要结局

• Best Overall Response(The best overall response recorded during the time period from the start of the treatment until end of the treatment period, progression or death (whichever was earlier), up to 869 days.)
• Phase I: Number of Patients With Objective Response: Complete Remission or Complete Remission With Incomplete Blood Count Recovery (CR+CRi)(The best overall response recorded during the time period from the start of the treatment until end of the treatment period, progression or death (whichever was earlier), up to 594 days.)
• Phase II: Event Free Survival(The patients that entered the trial, and measured from the date of randomization to the date of disease progression (treatment failure), relapse or death from any cause, whichever occurred first, up to 1000 days..)
• Best Eastern Co-operative Oncology Group (ECOG) Performance Score From Baseline Until End of Treatment(Baseline and End of Treatment (up to 869 days).)
• Phase II: Overall Survival(The patients that entered the trial, and measured from the date of randomisation until death from any cause, up to 1100 days..)
• Phase II: Relapse - Free Survival(The patients who achieved CR or CRi, and was measured from the date of attaining CR or CRi until the date of disease recurrence or death from any cause, whichever occurred first, up to 900 days.)
• Phase II: Remission Duration(The patients who achieved CR or CRi, and was measured from the date of attaining CR or CRi until the date of disease recurrence (relapse), up to 900 days.)
• Phase II: Time to Remission(The patients who achieved CR or CRi, and was measured from the date of attaining CR or CRi until the date of disease recurrence (relapse), up to 158 days.)
• Total Clearance (CL) of Volasertib in Plasma After i.v (Intravenous) Administration of Volasertib(Cycle 1: -0:05 hour (h), 0:30h, 1:00h, 1:30h, 2h, 3h, 4h, 24h, 96h, 216h, 335:55h, 336:30h, 337h, 337:30h, 338h, 339h, 340h, 648h after first drug administration.)
• Apparent Volume of Distribution of Volasertib at Steady State (VSS)(Cycle 1: -0:05 hour (h), 0:30h, 1:00h, 1:30h, 2h, 3h, 4h, 24h, 96h, 216h, 335:55h, 336:30h, 337h, 337:30h, 338h, 339h, 340h, 648h after first drug administration.)
• Dose Normalized Maximum Measured Concentration of Cytarabine in Plasma (Cmax, Norm)(Cycle 1: -0:05 hour (h), 0:30h, 1:00h, 1:30h, 2h, 3h, 4h, 24h, 96h, 216h, 335:55h, 336:30h, 337h, 337:30h, 338h, 339h, 340h, 648h after first drug administration.)
• Dose Normalized Area Under the Concentration-Time Curve of Cytarabine in Plasma Over the Time Interval From 0 Extrapolated up to 4 Hours(Cycle 1: -0:05 hour (h), 0:30h, 1:00h, 1:30h, 2h, 3h, 4h after first drug administration.)
• Absolute QTcF (QT Interval Corrected for Heart Rate Using Fridericia's Formula) Intervals(Baseline (Days -14 to -1) and day 1 (1 hour and 24 hours) after start of infusion.)
• QTcF (QT Interval Corrected for Heart Rate Using Fridericia's Formula) Change From Baseline at Cycle 1(Baseline (Days -14 to -1) and day 1 (1 hour and 24 hours) after start of infusion.)
• Phase I Schedule A: Number of Participants With Adverse Events (AEs) Graded According to Common Terminology Criteria for Adverse Events (CTCAE), Based on the Number of Patients With AEs With CTCAE Grade ≥3 During Cycle 1(First treatment cycle, up to 28 days.)
• Phase I Schedule B: Number of Participants With Adverse Events (AEs) Graded According to Common Terminology Criteria for Adverse Events (CTCAE), Based on the Number of Patients With AEs With CTCAE Grade ≥3 During Cycle 1(First treatment cycle, up to 28 days.)
• Phase I Schedule A: Number of Participants With Adverse Events (AEs) Graded According to Common Terminology Criteria for Adverse Events (CTCAE), Based on the Number of Patients With AEs With CTCAE Grade ≥3 During All Cycles(From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 615 days.)
• Phase I Schedule B: Number of Participants With Adverse Events (AEs) Graded According to Common Terminology Criteria for Adverse Events (CTCAE), Based on the Number of Patients With AEs With CTCAE Grade ≥3 During All Cycles(From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 597 days.)
• Phase II: Number of Participants With Adverse Events (AEs) Graded According to Common Terminology Criteria for Adverse Events (CTCAE), Based on the Number of Patients With AEs With CTCAE Grade ≥3 During All Cycles(From first drug administration until 21 days after the last trial drug administration in the last treatment cycle, up to 890 days.)