This is a Phase 1, open-label, dose escalation study to determine the safety and preliminary efficacy of voruciclib monotherapy in subjects with relapsed/refractory B cell malignancies or AML after failure of standard therapies or voruciclib in combination with venetoclax in subjects with relapsed or refractory AML
This is a Phase 1, open-label, 3 + 3 dose escalation and expansion study to determine the safety and preliminary efficacy of voruciclib monotherapy in subjects with relapsed/refractory B cell malignancies or AML after failure of prior standard therapies or voruciclib in combination with venetoclax in subjects with relapsed or refractory AML. Escalation to the next higher dose level will depend on demonstrated safety and tolerability at each dose level.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
84
Voruciclib will be administered orally
Voruciclib and Venetoclax will be administered orally
City of Hope
Duarte, California, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
Dana Farber Cancer Institute
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
New York University
New York, New York, United States
Duke University
Durham, North Carolina, United States
Oregon Health and Science University
Portland, Oregon, United States
MD Anderson
Houston, Texas, United States
University of Virginia
Charlottesville, Virginia, United States
...and 2 more locations
Determine the safety and tolerability of voruciclib
Safety will be measured by the incidence of all AEs and SAEs, timing, grade \[CTCAE v4.03\] severity, seriousness, relatedness. Tolerability will be measured by the incidence of DLTs (dose limiting toxicities)
Time frame: 2 years
Determine the safety and tolerability of voruciclib in combination with venetoclax in subjects with AML.
Safety will be measured by the incidence of all AEs and SAEs, timing, grade \[CTCAE v4.03\] severity, seriousness, relatedness. Tolerability will be measured by the incidence of DLTs (dose limiting toxicities)
Time frame: 2 years
Overall Response Rate (ORR)
defined as the sum of complete response (CR), complete remission with incomplete marrow recovery (CRi) and partial response (PR) for B-cell malignancies, or for AML the sum of CR/CRi rate by the 2017 European LeukemiaNet (ELN) criteria
Time frame: 2 years
Duration of Response (DOR)
defined as the time from the initial determination of response to the time of disease progression or death on study, which ever occurs first
Time frame: 2 years
Progression Free Survival (PFS)
defined as the time from the first dose of study drug administration (Cycle 1 Day 1) to disease recurrence or progression as defined by IWG criteria, or death on study
Time frame: 2 years
Evaluate the PK of voruciclib
Determined by the Area Under the Concentration time curve (AUC)
Time frame: 2 years
Evaluate the PK of voruciclib Cmax in combination with venetoclax Determined by the Area Under the Concentration time curve (AUC)
Determined by the Area Under the Concentration time curve (AUC)
Time frame: 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.