A Phase I/II, Multicenter, Open-Label, Multi-Arm Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Activity of Idasanutlin in Combination with either Chemotherapy or Venetoclax in the Treatment of Pediatric and Young Adult Patients with Relapsed/Refractory Acute Leukemias or Solid Tumors
Objective
The pharmacokinetic (PK) objectives for this study are as follows: To characterize the PK profile of idasanutlin as a single agent and in combination with chemotherapy or venetoclax on the basis of the following endpoints: Plasma concentration of idasanutlin (and M4 metabolite RO6802287, where relevant)as a single agent at specified timepoints
Plasma concentration of idasanutlin in combination with chemotherapy or venetoclax at specified time points:
To characterize the PK profile of venetoclax in combination with idasanutlin on the basis of the following endpoint: Plasma concentration of venetoclax at specified timepoints
