Pharmacokinetic Study of Venetoclax Tablets Crushed and Dissolved Into a Solution
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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. PO vs NG tube vs G-tube) * To determine the concentration of venetoclax in cerebral spinal fluid when administered as an oral solution
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Dzieci w wieku poniżej 39 lat.
- •Pacjenci z chorobami krwi (hematologicznymi nowotworami).
- •Dzieci ważące co najmniej 5,5 kg.
- •Pacjenci przyjmujący lek Wenetoclax w postaci płynnej, przygotowanej z rozgniecionych tabletek (doustnie lub przez sondę).
- •Pacjenci, którzy mogą otrzymywać inne leki chemioterapeutyczne jednocześnie z Wenetoclaxem.
✗ Disqualifies
- •Kobiety w ciąży.
- •Kobiety karmiące piersią (karmienie powinno zostać przerwane).
- •Mężczyźni i kobiety w wieku rozrodczym, którzy nie stosują skutecznej antykoncepcji.
Simplified criteria — AI translation
Trial details
- Minimum age
- 0 Years
- Maximum age
- 38 Years
- Last updated (source)
- October 1, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (6)
Children's Hospital Colorado
Aurora, United States
Children's Healthcare of Atlanta - Arthur M. Blank Hospital
Atlanta, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, United States
Children's Hospital of Philadelphia
Philadelphia, United States
Texas Children's Hospital
Houston, United States
Children's Hospital of Wisconsin
Milwaukee, United States
Trial contact
Site Public Contact
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 10/2/2026.
You can help another person
We fund the Radar, this site, and the development of our Grosz dla Życia fundraising platform from donations and our own resources. Every contribution, even a small one, really helps.