The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 116 of 350 for:    Gastrointestinal Stromal Tumors
Previous Study | Return to List | Next Study

Imatinib TDM in GIST

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05493215
Recruitment Status : Recruiting
First Posted : August 9, 2022
Last Update Posted : April 1, 2024
Sponsor:
Information provided by (Responsible Party):
Reema A. Patel, University of Kentucky

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Gastrointestinal Stromal Tumors Drug: Imatinib Phase 2

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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
Actual Study Start Date : March 26, 2024
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Name: Gleevec


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Incidence of Grade 3/4 adverse events attributable to imatinib per CTCAE v5.0 [ Time Frame: 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. [ Time Frame: 6 months ]
    Percent of patients achieving therapeutic levels of imatinib.

  2. Quality of Life based on the EORTC QLQ-C30 [ Time Frame: 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 [ Time Frame: 3 year ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05493215


Contacts
Layout table for location contacts
Contact: Yvonne A Taul, RN 859-323-2354 Yvonne.Taul@uky.edu

Locations
Layout table for location information
United States, Kentucky
Markey Cancer Center Recruiting
Lexington, Kentucky, United States, 40536
Contact: Yvonne Taul, RN    859-323-7628    yvonne.taul@uky.edu   
Sponsors and Collaborators
Reema A. Patel
Investigators
Layout table for investigator information
Principal Investigator: Reema Patel, MD University of Kentucky
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Reema A. Patel, Assistant Professor, University of Kentucky
ClinicalTrials.gov Identifier: NCT05493215    
Other Study ID Numbers: MCC-23-GI-131
First Posted: August 9, 2022    Key Record Dates
Last Update Posted: April 1, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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:
Layout table for MeSH terms
Gastrointestinal Stromal Tumors
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
 Gastrointestinal Diseases
Imatinib Mesylate
Tyrosine Kinase Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents