Pharmacokinetic Study of Venetoclax Tablets Crushed and Dissolved Into a Solution

Launched by CHILDREN'S HOSPITAL MEDICAL CENTER, CINCINNATI · Nov 8, 2023

Keywords

ClinConnect Summary

This clinical trial is studying how well venetoclax, a medication used to treat certain types of blood cancers like leukemia and lymphoma, works when the tablets are crushed and dissolved in liquid. This is important because some patients, especially children, may have trouble swallowing pills. The trial aims to understand how the body absorbs this medication when taken as a liquid solution, and it will also look into the safety of this method of administration.

To be eligible for the study, participants need to be children or young adults under 39 years old who are diagnosed with a blood cancer and weigh at least 5.5 kg. They should already be receiving venetoclax in liquid form, either by mouth or through feeding tubes. Throughout the study, participants will have blood tests to monitor how the medication is processed in their bodies. It's important to note that pregnant or breastfeeding women cannot join the trial due to potential risks to the baby. Overall, this research aims to ensure that patients can safely and effectively receive their treatment in a way that works best for them.

Gender

ALL

Eligibility criteria

• 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.