Imatinib TDM in GIST

Part of paid clinical trials in Lexington, Kentucky.

Sponsor
Reema A. Patel
Study ID
NCT05493215
Phase
PHASE2
Status
Recruiting
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Conditions

  • Gastrointestinal Stromal Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Mar 26, 2024
Status verified
May 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
28 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Imatinib TDM
    Patients with diagnosed gastrointestinal stromal tumor (GIST) who are currently being treated with imatinib.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Markey Cancer CenterLexingtonKentucky40536
Yvonne Taul, RN
[email protected]
859-323-7628

Find similar trials in Lexington, KY

By research site
Markey Cancer Center· Lexington, KY

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