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Pharmacokinetic Study of Venetoclax Tablets Crushed and Dissolved Into a Solution

A Pharmacokinetic Study of Venetoclax Tablets Crushed and Dissolved Into a Solution in Children and Young Adults With Hematologic Malignancies

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
0 Years to 38 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Pills

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "For patients who cannot swallow tablets, it is common to crush the tablets and dissolve them in liquid to create a solution."
  • "Peripheral blood will be drawn at multiple time points to evaluate venetoclax pharmacokinetics in patients who are receiving venetoclax solution made from crushed tablets as part of their oncology treatment."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how the body takes in and processes venetoclax when tablets are crushed and mixed into liquid. It also checks the safety of this liquid form. It is for people younger than 39 with blood cancer who are already receiving venetoclax this way.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Must be younger than 39 when joining the study.
  • May have any type of blood cancer.
  • Must already have a line in a vein or artery for blood draws.
  • Must weigh at least 5.5 kilograms (about 12 pounds).
  • Must be taking venetoclax liquid made from crushed tablets, as prescribed by their cancer doctor. It can be given by mouth, through a tube from the nose to the stomach, or through a tube placed directly into the stomach.
  • May take venetoclax alone or with other cancer medicines.

Who can't join

  • Cannot join if pregnant because venetoclax may harm an unborn baby or cause pregnancy loss.
  • Must stop breastfeeding while being treated with venetoclax because it may harm a nursing baby.
  • People who could become pregnant or cause a pregnancy cannot join unless they agree to use effective birth control during study treatment and for six months after it ends.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (6)

CO

GA

OH

PA

TX

WI