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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 3 year
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of Grade 3/4 adverse events attributable to imatinib per CTCAE v5.0
Secondary outcome measures
Average dose of imatinib required to achieve therapeutic levels and drug dose over 3 years
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 • NCT0311260334%
Anaemia
21%
Pyrexia
20%
Hypertension
19%
Alanine aminotransferase increased
18%
Blood creatinine increased
16%
Diarrhoea
15%
Pneumonia
15%
Neutropenia
15%
Fatigue
15%
Cough
13%
Thrombocytopenia
12%
Nausea
12%
Gamma-glutamyltransferase increased
12%
Aspartate aminotransferase increased
12%
Platelet count decreased
12%
Arthralgia
12%
Dyspnoea
12%
Upper respiratory tract infection
11%
Back pain
10%
Influenza
10%
Headache
10%
Nasopharyngitis
10%
Hypertriglyceridaemia
10%
Myalgia
9%
Vomiting
9%
Blood cholesterol increased
9%
Hypokalaemia
8%
Constipation
8%
Oedema peripheral
8%
Hypercholesterolaemia
8%
Conjunctivitis
8%
Insomnia
8%
Urinary tract infection
8%
Hyperglycaemia
7%
Dry eye
7%
Amylase increased
7%
Blood alkaline phosphatase increased
7%
Blood creatine phosphokinase increased
7%
Hyperkalaemia
6%
Leukopenia
6%
Lipase increased
6%
Pain in extremity
5%
COVID-19
5%
BK virus infection
5%
Fibrin D dimer increased
5%
Rhinorrhoea
5%
Hyperuricaemia
5%
Cytomegalovirus infection reactivation
5%
Hypomagnesaemia
4%
Bronchitis
4%
Tremor
4%
Abdominal pain
3%
Lower respiratory tract infection
2%
Sepsis
2%
Febrile neutropenia
2%
Bronchopulmonary aspergillosis
2%
COVID-19 pneumonia
2%
Herpes zoster
2%
Pneumonia bacterial
2%
Osteonecrosis
2%
Dyspepsia
2%
Cataract
2%
Pulmonary embolism
2%
Pneumothorax
2%
Asthenia
2%
Hypophosphataemia
1%
Generalised oedema
1%
Pancreatitis acute
1%
Oral candidiasis
1%
Mycobacterial infection
1%
Pseudomonal sepsis
1%
Respiratory tract infection fungal
1%
Gastrointestinal ulcer
1%
Ileus
1%
Atrial flutter
1%
Completed suicide
1%
Pulmonary oedema
1%
Hypotension
1%
Splenic haemorrhage
1%
Cardiac failure congestive
1%
Haematemesis
1%
Stomatitis
1%
Catheter site haemorrhage
1%
Angle closure glaucoma
1%
Bacterial translocation
1%
Melaena
1%
Meningitis cryptococcal
1%
General physical health deterioration
1%
Fungal infection
1%
Multiple organ dysfunction syndrome
1%
Squamous cell carcinoma
1%
Confusional state
1%
Brain abscess
1%
Cytomegalovirus infection
1%
Bacteraemia
1%
Systemic infection
1%
Enterococcal infection
1%
Erysipelas
1%
Meningitis viral
1%
Escherichia sepsis
1%
Pyelonephritis
1%
Pneumocystis jirovecii pneumonia
1%
Spinal compression fracture
1%
Respiratory tract infection viral
1%
Pneumonia cytomegaloviral
1%
Septic shock
1%
Lower respiratory tract infection fungal
1%
Respiratory tract infection
1%
Measles
1%
Pneumococcal infection
1%
Infusion related reaction
1%
Cytomegalovirus test positive
1%
Respiratory syncytial virus infection
1%
Respiratory tract infection bacterial
1%
Renal impairment
1%
Tracheitis
1%
Depressed level of consciousness
1%
SARS-CoV-2 test positive
1%
Anastomotic complication
1%
Decreased appetite
1%
Acute kidney injury
1%
Pleuritic pain
1%
Squamous cell carcinoma of skin
1%
White blood cell count decreased
1%
Syncope
1%
Dehydration
1%
Tendon disorder
1%
Skin squamous cell carcinoma recurrent
1%
Organising pneumonia
1%
Epilepsy
1%
Basal cell carcinoma
1%
Alveolar proteinosis
1%
Vulvovaginal inflammation
1%
Hypoxia
1%
Pneumonitis
1%
Post transplant lymphoproliferative disorder
1%
Spinal cord compression
1%
Acute respiratory distress syndrome
1%
Haemorrhage intracranial
1%
Tachypnoea
1%
Deep vein thrombosis
1%
Loss of personal independence in daily activities
1%
Respiratory failure
1%
Upper respiratory tract inflammation
1%
Toxic epidermal necrolysis
1%
Pruritus
1%
Anal abscess
1%
Corneal erosion
1%
Corneal perforation
1%
Adenovirus reactivation
1%
Muscular weakness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Ruxolitinib
Best Available Therapy
Ruxolitinib Cross-Over Period
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.My organs are functioning normally.My GIST tumor has a KIT or PDGFRA mutation, but not D842V.I have another type of cancer besides the one being treated.I am not taking medication that strongly affects certain liver enzymes.I am allergic to imatinib or similar drugs.My cancer has the PDGFRA D842V mutation.I am fully active or can carry out light work.I do not have any unmanaged ongoing illnesses.I am currently taking warfarin as a blood thinner.I started taking imatinib less than 3 months ago or will start within a month.I had chemotherapy for another cancer, finished within the last 6 months, and currently show no signs of that cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Imatinib TDM
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research endeavor still welcoming new participants?
"Clinicaltrials.gov's data reveals that this trial, which was originally published on November 1st 2022 and last updated October 13th 2022, is no longer recruiting patients. However, there are 41 other trials searching for volunteers presently."
Answered by AI
To what extent is Imatinib hazardous to patients?
"Although Phase 2 clinical trials have provided evidence that imatinib is safe, it has not been proven to be efficacious. Thus, our team at Power gave Imatinib a score of two on the safety scale."
Answered by AI
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