Pharmacokinetic Study of Venetoclax Tablets Crushed and Dissolved Into a Solution
NCT ID: NCT06131801
Last Updated: 2025-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
30 participants
OBSERVATIONAL
2023-11-15
2027-12-01
Brief Summary
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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. PO vs NG tube vs G-tube)
* To determine the concentration of venetoclax in cerebral spinal fluid when administered as an oral solution
Detailed Description
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Conditions
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Keywords
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Children and Young Adults
Children and Young Adults who are prescribed venetoclax made from crushed tablets as part of their clinical care.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
0 Years
38 Years
ALL
No
Sponsors
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Children's Hospital Medical Center, Cincinnati
OTHER
Responsible Party
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Principal Investigators
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Lauren Pommert, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
Locations
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Children's Hospital Colorado
Aurora, Colorado, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Central Contacts
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Facility Contacts
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Kelly Faulk, MD
Role: primary
Tasleema Patel
Role: primary
Kira Mielke
Role: primary
Kara Nelson
Role: backup
Other Identifiers
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Venetoclax PK
Identifier Type: -
Identifier Source: org_study_id