Health TrialsbyHealthPanel

Pharmacokinetic Study of Venetoclax Tablets Crushed and Dissolved Into a Solution

ConditionsHematologic MalignancyLeukemiaLymphomaAcute Lymphocytic LeukemiaALLAcute Myelogenous LeukemiaAMLChronic Myelogenous LeukemiaCMLMyeloproliferative NeoplasmNon Hodgkin LymphomaHodgkin LymphomaDiffuse Large B Cell LymphomaFollicular LymphomaBurkitt LymphomaT-cell LymphomaB Cell LymphomaPeripheral T Cell LymphomaCutaneous B-Cell Lymphoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-38
SponsorChildren's Hospital Medical Center, Cincinnati

About this 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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial population

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. Patients must be \<39 years of age at time of study enrollment.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • 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.

    Other intervention

    Participants will receive Venetoclax as prescribed by their treating provider as part of their clinical care.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Children and Young Adults1 intervention

Trial outcomes

Primary outcomes

1

Clearance (CL) as measured by PK sampling (Peripheral Blood; Required)

PK parameters of venetoclax will be described in peripheral blood including: the observed peak plasma concentration (Cmax)

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.
2

Clearance (CL) as measured by PK sampling (Peripheral Blood; Required)

PK parameters of venetoclax will be described in peripheral blood including: the time to peak (Tmax)

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.
3

Clearance (CL) as measured by PK sampling (Peripheral Blood; Required)

PK parameters of venetoclax will be described in peripheral blood including: the apparent terminal phase elimination rate constant (β)

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.
4

Clearance (CL) as measured by PK sampling (Peripheral Blood; Required)

PK parameters of venetoclax will be described in peripheral blood including: the terminal-phase elimination half-life (T1/2)

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.

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Children's Hospital Medical Center, Cincinnati

Lead sponsor

Source ClinicalTrials.gov
Apply now