search
Back to results

Imatinib TDM in GIST

Primary Purpose

Gastrointestinal Stromal Tumors

Status
Not yet recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Imatinib
Sponsored by
Reema A. Patel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastrointestinal Stromal Tumors

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Markey Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Imatinib TDM

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Percent of patients achieving therapeutic levels of imatinib.
Percent of patients achieving therapeutic levels of imatinib.
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.
Average dose of imatinib required to achieve therapeutic levels and drug dose over 3 years

Full Information

First Posted
August 5, 2022
Last Updated
September 7, 2023
Sponsor
Reema A. Patel
search

1. Study Identification

Unique Protocol Identification Number
NCT05493215
Brief Title
Imatinib TDM in GIST
Official Title
A Phase 2 Study of Imatinib Therapeutic Drug Monitoring in Gastrointestinal Stromal Tumor
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Reema A. Patel

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Stromal Tumors

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Imatinib TDM
Arm Type
Experimental
Arm Description
Patients with diagnosed gastrointestinal stromal tumor (GIST) who are currently being treated with imatinib.
Intervention Type
Drug
Intervention Name(s)
Imatinib
Other Intervention Name(s)
Gleevec
Intervention Description
Therapeutic drug level monitoring with plans to increase to adjust drug dosage based on levels and patient symptoms.
Primary Outcome Measure Information:
Title
Incidence of Grade 3/4 adverse events attributable to imatinib per CTCAE v5.0
Description
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 Outcome Measure Information:
Title
Percent of patients achieving therapeutic levels of imatinib.
Description
Percent of patients achieving therapeutic levels of imatinib.
Time Frame
6 months
Title
Quality of Life based on the EORTC QLQ-C30
Description
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
Title
Average dose of imatinib required to achieve therapeutic levels and drug dose over 3 years
Time Frame
3 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yvonne A Taul, RN
Phone
859-323-2354
Email
Yvonne.Taul@uky.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reema Patel, MD
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
Markey Cancer Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yvonne Taul, RN
Phone
859-323-7628
Email
yvonne.taul@uky.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Imatinib TDM in GIST

We'll reach out to this number within 24 hrs