NCT06131801 · Children's Hospital Medical Center, Cincinnati
Pharmacokinetic Study of Venetoclax Tablets Crushed and Dissolved Into a Solution
What this study is about
The use of venetoclax-based therapies for pediatric patients with relapsed or refractory malignancies is increasingly common outside of the clinical trial setting. For patients who cannot swallow tablets, it is common to crush the tablets and dissolve them in liquid to create a solution.
View original scientific description
The use of venetoclax-based therapies for pediatric patients with relapsed or refractory malignancies is increasingly common outside of the clinical trial setting. For patients who cannot swallow tablets, it is common to crush the tablets and dissolve them in liquid to create a solution. However, no PK data exists in adults or children using crushed tablets dissolved in liquid in this manner, and as a result, the venetoclax exposure with this solution is unknown. Primary Objectives • To determine the pharmacokinetics of venetoclax when commercially available tablets are crushed and dissolved into a solution Secondary Objectives * To evaluate the safety of crushed venetoclax tablets administered as an oral solution * To determine the pharmacokinetics of venetoclax solution in patients receiving concomitant strong and moderate CYP3A inhibitors * To determine potential pharmacokinetic differences based on route of venetoclax solution administration (ie.
Interventions
OTHER
1. Drug: The Venetoclax PK study is collecting bodily fluid samples (ie., whole blood and optional cerebrospinal fluid) of patients prescribed venetoclax as crushed tablets per standard of care.
Participants will receive Venetoclax as prescribed by their treating provider as part of their clinical care.
Primary outcome measures
Clearance (CL) as measured by PK sampling (Peripheral Blood; Required)
Time frame: Blood will be collected on one PK day between Days 5-12 after completion of the venetoclax dose ramp-up : within 1hr prior to the administration of venetoclax, then 2hrs, 5hrs, 12hrs, 18hrs and 24hrs after the administration of venetoclax.
PK parameters of venetoclax will be described in peripheral blood including: the observed peak plasma concentration (Cmax)
Clearance (CL) as measured by PK sampling (Peripheral Blood; Required)
Time frame: Blood will be collected on one PK day between Days 5-12 after completion of the venetoclax dose ramp-up : within 1hr prior to the administration of venetoclax, then 2hrs, 5hrs, 12hrs, 18hrs and 24hrs after the administration of venetoclax.
PK parameters of venetoclax will be described in peripheral blood including: the time to peak (Tmax)
Clearance (CL) as measured by PK sampling (Peripheral Blood; Required)
Time frame: Blood will be collected on one PK day between Days 5-12 after completion of the venetoclax dose ramp-up : within 1hr prior to the administration of venetoclax, then 2hrs, 5hrs, 12hrs, 18hrs and 24hrs after the administration of venetoclax.
PK parameters of venetoclax will be described in peripheral blood including: the apparent terminal phase elimination rate constant (β)
Clearance (CL) as measured by PK sampling (Peripheral Blood; Required)
Time frame: Blood will be collected on one PK day between Days 5-12 after completion of the venetoclax dose ramp-up : within 1hr prior to the administration of venetoclax, then 2hrs, 5hrs, 12hrs, 18hrs and 24hrs after the administration of venetoclax.
PK parameters of venetoclax will be described in peripheral blood including: the terminal-phase elimination half-life (T1/2)
Clearance (CL) as measured by PK sampling (Peripheral Blood; Required)
Time frame: Blood will be collected on one PK day between Days 5-12 after completion of the venetoclax dose ramp-up : within 1hr prior to the administration of venetoclax, then 2hrs, 5hrs, 12hrs, 18hrs and 24hrs after the administration of venetoclax.
PK parameters of venetoclax will be described in peripheral blood including: the areas under plasma concentration curve (AUC) over a 24-hour dose interval (AUC0-24) or for infinite time (AUC0-∞)
Clearance (CL) as measured by PK sampling (Peripheral Blood; Required)
Time frame: Blood will be collected on one PK day between Days 5-12 after completion of the venetoclax dose ramp-up : within 1hr prior to the administration of venetoclax, then 2hrs, 5hrs, 12hrs, 18hrs and 24hrs after the administration of venetoclax.
PK parameters of venetoclax will be described in peripheral blood including: oral clearance (CL/F) of venetoclax
Clearance (CL) as measured by PK sampling (Cerebrospinal Fluid; Optional)
Time frame: Around Days 8, 15, 22, and/or 28, all +/- 3 days. Not all patients will have CSF collected at these time points.
PK parameters of venetoclax will be described in cerebral spinal fluid including: the observed peak plasma concentration (Cmax)
Clearance (CL) as measured by PK sampling (Cerebrospinal Fluid; Optional)
Time frame: Around Days 8, 15, 22, and/or 28, all +/- 3 days. Not all patients will have CSF collected at these time points.
PK parameters of venetoclax will be described in cerebral spinal fluid including: the time to peak (Tmax)
Clearance (CL) as measured by PK sampling (Cerebrospinal Fluid; Optional)
Time frame: Around Days 8, 15, 22, and/or 28, all +/- 3 days. Not all patients will have CSF collected at these time points.
PK parameters of venetoclax will be described in cerebral spinal fluid including: the apparent terminal phase elimination rate constant (β)
Clearance (CL) as measured by PK sampling (Cerebrospinal Fluid; Optional)
Time frame: Around Days 8, 15, 22, and/or 28, all +/- 3 days. Not all patients will have CSF collected at these time points.
PK parameters of venetoclax will be described in cerebral spinal fluid including: the terminal-phase elimination half-life (T1/2)
Clearance (CL) as measured by PK sampling (Cerebrospinal Fluid; Optional)
Time frame: Around Days 8, 15, 22, and/or 28, all +/- 3 days. Not all patients will have CSF collected at these time points.
PK parameters of venetoclax will be described in cerebral spinal fluid including: the areas under plasma concentration curve (AUC) over a 24-hour dose interval (AUC0-24) or for infinite time (AUC0-∞)
Clearance (CL) as measured by PK sampling (Cerebrospinal Fluid; Optional)
Time frame: Around Days 8, 15, 22, and/or 28, all +/- 3 days. Not all patients will have CSF collected at these time points.
PK parameters of venetoclax will be described in cerebral spinal fluid including: oral clearance (CL/F)
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Age: Patients must be \<39 years of age at time of study enrollment
- Diagnosis: Patients may have a diagnosis of any hematologic malignancy
- Central access: Patients must have an existing venous or arterial access line for PK blood draws
- Weight requirement: Patients must weigh at least 5.5 kg at the time of enrollment
- Venetoclax: Patients must be receiving any dose of venetoclax given as a solution made from crushed tablets by mouth (PO) or via nasogastric (NG), or G-tube as prescribed by their treating oncologist.
- Concurrent chemotherapy medications: Patients may receive venetoclax as a single agent or in combination with any other chemotherapeutic agents.
Exclusion criteria
- Pregnant women are excluded from this study because venetoclax has the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with venetoclax, breastfeeding should be discontinued if the mother is treated with venetoclax.
- Males or females of reproductive potential may not participate unless they have agreed to use an effective contraceptive method while on study treatment and for six months following completion.
Where
- Aurora, Colorado
- Cincinnati, Ohio
- Philadelphia, Pennsylvania
- Houston, Texas
- Milwaukee, Wisconsin
Related conditions & keywords
Frequently asked questions
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A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
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Will I receive a placebo instead of treatment?
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Data: ClinicalTrials.gov · synced Jun 4, 2026 · Source of record for eligibility and locations