Health TrialsbyHealthPanel

Imatinib TDM in GIST

ConditionGastrointestinal Stromal Tumors
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorReema A. Patel

About this trial

Imatinib can lead to long recurrence free survival in patients diagnosed with gastrointestinal stromal tumors (GIST); however side effects can significantly hinder quality of life for our patients. This study will use therapeutic drug monitoring to improve quality of life and symptoms and assess how many patients maintain therapeutic levels. Free drug levels and pharmokinetics of imatinib will also be monitored.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically or cytologically confirmed GIST with KIT mutation or PDGFRA mutation (non-D842V)

Currently receiving imatinib initiated within the last 3 months or to be started in the next 1 month

Prior systemic chemotherapy for other malignancy is allowed as long as it was completed within the past 6 months and there is no evidence of disease

Age ≥18 years

Disqualifiers

Presence of PDGFRA D842V mutation

Known allergy to imatinib or allergic reactions to compounds of similar chemical or biologic composition to the study drug

Concomitant anticoagulation with oral warfarin.

Use of strong inhibitors or inducers of CYP3A or CYP3A4, drugs metabolized by CYP3A4 or CYP2D6

Trial design

Design model

Single group

Treatments tested in this trial

  • Imatinib

    Drug

    Therapeutic drug level monitoring with plans to increase to adjust drug dosage based on levels and patient symptoms.

Treatment groups

28 Participants
are divided into 1 treatment group
Group A: Imatinib TDMExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of Grade 3/4 adverse events attributable to imatinib per CTCAE v5.0

To compare the incidence of Grade 3/4 adverse events attributable to imatinib per CTCAE v5.0 in patients who receive therapeutic drug monitoring (TDM) with imatinib to a historical control.

Time frame
6 months

Secondary outcomes

1

Percent of patients achieving therapeutic levels of imatinib.

Percent of patients achieving therapeutic levels of imatinib.

Time frame
6 months
2

Quality of Life based on the EORTC QLQ-C30

Quality of Life will be assessed using the EORTC Core Quality of Life questionnaire (EORTC QLQ-C30). The EORTC QLQ-C30 is designed to measure cancer patients' physical, psychological and social functions. It incorporates five functional scales, three symptom scales, a global health status, financial impact, and single items assessing additional symptoms. All scales and single-item measures are transformed so that scores range from 0-100; higher scores represent a higher response level.

Time frame
6 months
3

Average dose of imatinib required to achieve therapeutic levels and drug dose over 3 years

Time frame
3 year

Other outcomes

Sponsors and contacts

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

Reema A. Patel

Lead sponsor

University of Kentucky

Sponsor institution

Source ClinicalTrials.gov
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