An open-label, dose-escalation study to assess the safety and pharmacokinetics (PK), to determine the dose limiting toxicity (DLT) and the recommended Phase 2 dose (RPTD), and to assess the preliminary efficacy of alvocidib with venetoclax when co-administered in participants with relapsed or refractory (R/R) acute myeloid leukemia (AML).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
tablet, oral
Intravenous
USC Norris Cancer Center /ID# 170844
Los Angeles, California, United States
UC Irvine /ID# 201093
Orange, California, United States
Tmax of venetoclax
Time to maximum plasma concentration (Tmax) of venetoclax
Time frame: Approximately 32 days after first dose of study drug
Clearance of Alvocidib
Clearance (CL) of alvocidib
Time frame: Approximately 32 days after first dose of study drug
AUC0-∞ of Alvocidib
Area under the plasma concentration-time curve from 0 to infinity (AUC0-∞) post-dose of alvocidib
Time frame: Approximately 32 days after first dose of study drug
Cmax of Venetoclax
Maximum plasma concentration (Cmax) of venetoclax
Time frame: Approximately 32 days after first dose of study drug
Half-life (t1/2) of Alvocidib
Half-life (t1/2) of alvocidib
Time frame: Approximately 32 days after first dose of study drug
AUC0-24 Post-dose of Venetoclax
Area under the plasma concentration-time curve from 0 to 24 hours (AUC24) post-dose of venetoclax.
Time frame: Approximately 32 days after first dose of study drug
Cmax of Alvocidib
Maximum plasma concentration (Cmax) of alvocidib.
Time frame: Approximately 32 days after first dose of study drug
AUCt Post-dose of Alvocidib
Area under the plasma concentration-time curve from time zero to time t (AUCt) post-dose alvocidib.
Time frame: Approximately 32 days after first dose of study drug
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University of California, Davis Comprehensive Cancer Center /ID# 170799
Sacramento, California, United States
Sylvester Comprehensive Cancer /ID# 170761
Miami, Florida, United States
Indiana Blood & Marrow Transpl /ID# 170793
Indianapolis, Indiana, United States
NYU Langone Medical Center /ID# 201559
New York, New York, United States
Weill Cornell Medical College /ID# 170800
New York, New York, United States
Duke University Medical Center /ID# 170842
Durham, North Carolina, United States
University of Pittsburgh Medic /ID# 170790
Pittsburgh, Pennsylvania, United States
Universitaetsklinikum Dresden /ID# 168636
Dresden, Germany
...and 4 more locations
Dose Escalation Phase: Recommended Phase 2 dose (RPTD) for Venetoclax and Alvocidib
RPTD will be determined using available safety and pharmacokinetics data upon completion of the dose escalation phase.
Time frame: Minimum first cycle of dosing (up to 28 days)
Complete Response (CR) Rate
CR is defined as the proportion of participants with documented complete response (CR) based on International Working Group (IWG) criteria.
Time frame: Up to approximately 8 months
Combined CR Rate
Combined CR rate is defined as CR + CRi (CR with incomplete blood count recovery) based on IWG criteria.
Time frame: Up to approximately 8 months
Objective Response Rate (ORR)
ORR is defined as the proportion of participants with documented partial response (PR) or better based on IWG criteria.
Time frame: Up to approximately 18 months