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Tyrosine Kinase Inhibitor

Imatinib for Gastrointestinal Stromal Cancer

Phase 2
Recruiting
Led By Reema Patel, MD
Research Sponsored by Reema A. Patel
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will use therapeutic drug monitoring to improve quality of life for patients with gastrointestinal stromal tumors (GIST) who are taking imatinib.

Who is the study for?
Adults over 18 with a specific type of tumor called GIST and certain genetic mutations can join. They should be starting or have recently started taking Imatinib, have good performance status, and normal organ function. Those with uncontrolled illnesses, on warfarin, other cancer treatments within 6 months without disease evidence, or allergies to Imatinib cannot participate.
What is being tested?
The trial is testing if monitoring the levels of the drug Imatinib in the blood can improve life quality for patients with gastrointestinal stromal tumors (GIST) while maintaining its effectiveness. It involves checking free drug levels and how the body processes the drug.
What are the potential side effects?
Imatinib may cause side effects that affect patient comfort such as nausea, muscle cramps, rash, fatigue, abdominal pain and edema. The study aims to manage these by adjusting dosage based on individual drug level monitoring.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of Grade 3/4 adverse events attributable to imatinib per CTCAE v5.0
Secondary study objectives
Percent of patients achieving therapeutic levels of imatinib.
Quality of Life based on the EORTC QLQ-C30

Side effects data

From 2022 Phase 3 trial • 330 Patients • NCT03112603
34%
Anaemia
21%
Pyrexia
20%
Hypertension
19%
Alanine aminotransferase increased
18%
Blood creatinine increased
16%
Diarrhoea
15%
Fatigue
15%
Pneumonia
15%
Neutropenia
15%
Cough
13%
Thrombocytopenia
12%
Arthralgia
12%
Nausea
12%
Aspartate aminotransferase increased
12%
Upper respiratory tract infection
12%
Gamma-glutamyltransferase increased
12%
Platelet count decreased
12%
Dyspnoea
11%
Back pain
10%
Nasopharyngitis
10%
Influenza
10%
Myalgia
10%
Headache
10%
Hypertriglyceridaemia
9%
Vomiting
9%
Blood cholesterol increased
9%
Hypokalaemia
8%
Hyperglycaemia
8%
Oedema peripheral
8%
Conjunctivitis
8%
Constipation
8%
Hypercholesterolaemia
8%
Urinary tract infection
8%
Insomnia
7%
Blood creatine phosphokinase increased
7%
Hyperkalaemia
7%
Blood alkaline phosphatase increased
7%
Amylase increased
7%
Dry eye
6%
Pain in extremity
6%
Leukopenia
6%
Lipase increased
5%
Hyperuricaemia
5%
COVID-19
5%
Hypomagnesaemia
5%
BK virus infection
5%
Fibrin D dimer increased
5%
Cytomegalovirus infection reactivation
5%
Rhinorrhoea
4%
Bronchitis
4%
Abdominal pain
4%
Tremor
3%
Lower respiratory tract infection
2%
Dyspepsia
2%
Bronchopulmonary aspergillosis
2%
Asthenia
2%
Osteonecrosis
2%
Hypophosphataemia
2%
COVID-19 pneumonia
2%
Pneumonia bacterial
2%
Sepsis
2%
Herpes zoster
2%
Pneumothorax
2%
Pulmonary embolism
2%
Cataract
2%
Febrile neutropenia
1%
General physical health deterioration
1%
Respiratory failure
1%
Post transplant lymphoproliferative disorder
1%
Squamous cell carcinoma of skin
1%
Pneumococcal infection
1%
Tracheitis
1%
Loss of personal independence in daily activities
1%
Haemorrhage intracranial
1%
Pancreatitis acute
1%
Meningitis viral
1%
Oral candidiasis
1%
Pseudomonal sepsis
1%
Respiratory syncytial virus infection
1%
Bacterial translocation
1%
Respiratory tract infection
1%
Deep vein thrombosis
1%
Anal abscess
1%
Epilepsy
1%
Tendon disorder
1%
Decreased appetite
1%
Cytomegalovirus infection
1%
Enterococcal infection
1%
Systemic infection
1%
Fungal infection
1%
Pneumonia cytomegaloviral
1%
Spinal cord compression
1%
Cytomegalovirus test positive
1%
Meningitis cryptococcal
1%
Mycobacterial infection
1%
Muscular weakness
1%
Septic shock
1%
White blood cell count decreased
1%
Syncope
1%
Measles
1%
Dehydration
1%
Basal cell carcinoma
1%
Respiratory tract infection viral
1%
Anastomotic complication
1%
Vulvovaginal inflammation
1%
Stomatitis
1%
Catheter site haemorrhage
1%
Respiratory tract infection fungal
1%
Depressed level of consciousness
1%
Escherichia sepsis
1%
Acute respiratory distress syndrome
1%
Erysipelas
1%
Pneumocystis jirovecii pneumonia
1%
Spinal compression fracture
1%
Hypotension
1%
Tachypnoea
1%
Generalised oedema
1%
Multiple organ dysfunction syndrome
1%
Bacteraemia
1%
Lower respiratory tract infection fungal
1%
Brain abscess
1%
Infusion related reaction
1%
Adenovirus reactivation
1%
Acute kidney injury
1%
Renal impairment
1%
Alveolar proteinosis
1%
Hypoxia
1%
Organising pneumonia
1%
Pleuritic pain
1%
Pneumonitis
1%
Pulmonary oedema
1%
Upper respiratory tract inflammation
1%
Toxic epidermal necrolysis
1%
Pruritus
1%
Gastrointestinal ulcer
1%
Atrial flutter
1%
Cardiac failure congestive
1%
Haematemesis
1%
Melaena
1%
Splenic haemorrhage
1%
Corneal erosion
1%
Corneal perforation
1%
Angle closure glaucoma
1%
Ileus
1%
Pyelonephritis
1%
Respiratory tract infection bacterial
1%
SARS-CoV-2 test positive
1%
Skin squamous cell carcinoma recurrent
1%
Squamous cell carcinoma
1%
Completed suicide
1%
Confusional state
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ruxolitinib
Best Available Therapy
Ruxolitinib Cross-Over Period

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Imatinib TDMExperimental Treatment1 Intervention
Patients with diagnosed gastrointestinal stromal tumor (GIST) who are currently being treated with imatinib.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Imatinib
2011
Completed Phase 3
~3940

Find a Location

Who is running the clinical trial?

Reema A. PatelLead Sponsor
1 Previous Clinical Trials
178 Total Patients Enrolled
Reema Patel, MDPrincipal InvestigatorUniversity of Kentucky

Media Library

Imatinib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05493215 — Phase 2
Gastrointestinal Stromal Tumors Research Study Groups: Imatinib TDM
Gastrointestinal Stromal Tumors Clinical Trial 2023: Imatinib Highlights & Side Effects. Trial Name: NCT05493215 — Phase 2
Imatinib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05493215 — Phase 2
~15 spots leftby Dec 2025
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