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Imatinib TDM in GIST

Sponsor
Reema A. Patel (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05493215
Collaborator
(none)
28
Enrollment
1
Location
1
Arm
39
Anticipated Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
28 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase 2 Study of Imatinib Therapeutic Drug Monitoring in Gastrointestinal Stromal Tumor
Anticipated Study Start Date :
Sep 1, 2022
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Dec 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Imatinib TDM

Patients with diagnosed gastrointestinal stromal tumor (GIST) who are currently being treated with imatinib.

Drug: Imatinib
Therapeutic drug level monitoring with plans to increase to adjust drug dosage based on levels and patient symptoms.
Other Names:
  • Gleevec

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of Grade 3/4 adverse events attributable to imatinib per CTCAE v5.0 [6 months]

      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.

    Secondary Outcome Measures

    1. Percent of patients achieving therapeutic levels of imatinib. [6 months]

      Percent of patients achieving therapeutic levels of imatinib.

    2. Quality of Life based on the EORTC QLQ-C30 [6 months]

      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.

    3. Average dose of imatinib required to achieve therapeutic levels and drug dose over 3 years [3 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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

    • ECOG performance status of 0 or 1

    • Normal organ function

    Exclusion Criteria:

    • 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

    • Uncontrolled intercurrent illness

    • Concurrent malignancy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Markey Cancer Center Lexington Kentucky United States 40536

    Sponsors and Collaborators

    • Reema A. Patel

    Investigators

    • Principal Investigator: Reema Patel, MD, University of Kentucky

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Reema A. Patel, Assistant Professor, University of Kentucky
    ClinicalTrials.gov Identifier:
    NCT05493215
    Other Study ID Numbers:
    • MCC-22-GI-123
    First Posted:
    Aug 9, 2022
    Last Update Posted:
    Aug 9, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Gastrointestinal Stromal Tumors
    Imatinib Mesylate

    Study Results

    No Results Posted as of Aug 9, 2022