A Phase 1, Open-Label, Study of Voruciclib in Subjects with Relapsed and/or Refractory B Cell Malignancies or Acute Myeloid Leukemia After Failure of Prior Standard Therapies and Voruciclib in Combination with Venetoclax in Subjects with Relapsed and/or Refractory Acute Myeloid Leukemia
Categories (click each to see list of all clinical trials associated with that category): Lymphoma/CLL (ONC)
Current Status: Open
Phase: I
Principal Investigator: Bhatt, Vijaya
Contact Information:
Sarah Snook
sarah.snook@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT03547115?term=NCT03547115&rank=1
Summary
STUDY OBJECTIVES
Primary Objectives
Determine the safety and tolerability of voruciclib and identify a safe and minimum biologically
effective dose (mBED) of voruciclib monotherapy in subjects with relapsed or refractory B-cell
malignancies and relapsed or refractory AML
Determine the safety and tolerability, and identify the safe and mBED of voruciclib in
combination with venetoclax in subjects with relapsed or refractory AML
Secondary Objectives
Evaluate the potential efficacy of voruciclib monotherapy based on:
- International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria for
CLL/SLL or the Lugano classification of response assessment for lymphoma, as appropriate, for subjects with B-cell malignancies
- The 2017 European LeukemiaNet (ELN) criteria for subjects with AML
Evaluate the potential efficacy of voruciclib in combination with venetoclax in subjects with
AML based on the 2017 ELN criteria
Evaluate the pharmacokinetics (PK) of voruciclib administered as monotherapy, and the PK of
voruciclib and venetoclax when administered in combination
Exploratory Objectives
Determine the effect of voruciclib monotherapy and voruciclib in combination with venetoclax
(AML only) on biomarkers and functional activities of proteins in the apoptotic pathway
Correlate anti-tumor activity with baseline tumor characteristics