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Tyrosine Kinase Inhibitor
Imatinib for Advanced Thyroid Cancer
Phase 1
Recruiting
Led By Jennifer Spratlin, MD FRCPC
Research Sponsored by AHS Cancer Control Alberta
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 months
Awards & highlights
Study Summary
This trial is testing whether giving imatinib to patients with progressive thyroid cancer that has become resistant to radioactive iodine will improve the cancer.
Who is the study for?
This trial is for adults with advanced papillary thyroid cancer that has spread and no longer responds to radioiodine treatment. Participants must have a certain level of blood cell counts, normal organ function tests, and be able to follow the study plan. Pregnant or breastfeeding individuals are excluded, as well as those with other significant health issues or recent treatments that could affect safety.Check my eligibility
What is being tested?
The trial is testing Imatinib Oral Tablet's ability to restore sensitivity to radioiodine in thyroid cancer cells by blocking PDGFRα protein function. This could potentially shrink tumors and improve disease control in patients whose cancers have become resistant to standard radioactive iodine therapy.See study design
What are the potential side effects?
Imatinib may cause side effects such as fluid retention, muscle cramps, fatigue, digestive issues like nausea or diarrhea, skin rash, lowered resistance to infections due to reduced white blood cell counts, and potential liver enzyme elevations.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Restore iodine uptake
Secondary outcome measures
Decrease overall tumor burden
Side effects data
From 2022 Phase 2 trial • 54 Patients • NCT0302304626%
Febrile neutropenia
17%
Sepsis
9%
Mucositis oral
4%
Upper gastrointestinal hemorrhage
4%
Intracranial hemorrhage
4%
Hypotension
4%
Hypertension
4%
Enterocolitis
2%
Atrial fibrillation
2%
Lower gastrointestinal hemorrhage
2%
Delirium
2%
Oropharyngeal pain
2%
Gastric hemorrhage
2%
Abdominal pain
2%
Diarrhea
2%
Fungemia
2%
Typhlitis
2%
Myocardial infarction
2%
Fibrinogen decreased
2%
Endophthalmitis
2%
Multi-organ failure
2%
Kidney infection
2%
Peripheral motor neuropathy
2%
Hypoxia
2%
Sinus bradycardia
2%
Edema limbs
2%
Small intestinal obstruction
2%
Aspiration
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Chemotherapy)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Imatinib oral100mg tabletsExperimental Treatment1 Intervention
A standard 3+3 trial design will be utilized for the imatinib dosing. In general, patients will be treated in cohorts of 3-6 with escalating doses of imatinib using oral 100mg tablets.
Dose Level -1=100mg, +1=200mg (starting dose for cohort 1), +2=300mg, +3=400mg, +4=600mg (if needed).
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Who is running the clinical trial?
AHS Cancer Control AlbertaLead Sponsor
182 Previous Clinical Trials
36,194 Total Patients Enrolled
Alberta Cancer FoundationOTHER
17 Previous Clinical Trials
5,615 Total Patients Enrolled
Jennifer Spratlin, MD FRCPCPrincipal InvestigatorAlberta Health services
1 Previous Clinical Trials
45 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a medical condition that makes it very risky for you to take the study drug.You have thyroid cancer that does not respond to radioiodine treatment according to specific criteria.You have cancer that has come back, spread, or is in an advanced stage that cannot be treated with surgery or radiation to cure it.You have an autoimmune disease that affects your kidneys.Currently taking multiple medications to treat HIVYou have had or currently have other types of cancer, except for certain cases.You have a medical condition that affects how your body absorbs nutrients.You have a history of significant bleeding related to cancer.You had a serious pancreas problem in the past year or have a long-term pancreas issue.You have moderate to severe protein in your urine at the start of the study.You are currently taking strong medications that can affect how the study drug works.You should be able to perform daily activities with little to no restriction because of your health.Your levels of certain minerals in your blood (potassium, phosphorus, magnesium, and calcium) are too low, but can be fixed with supplements before starting the study drug.You have untreated cancer that has spread to your brain or the tissues covering your brain.You have high blood pressure that is not being treated or controlled.You have been diagnosed with a specific type of thyroid cancer called papillary thyroid cancer.Your white blood cell count and platelet count need to be within certain ranges.Your liver enzymes and alkaline phosphatase should not be more than 5 times the normal limit, and your creatinine levels should not be more than 1.5 times the normal limit.Your levels of amylase and lipase in the blood should not be higher than 1.5 times the upper limit of normal.You have a specific type of disease that can be measured with a CT scan.Your body does not absorb radioactive iodine well.You had a heart attack, stroke, or mini-stroke (TIA) within the last 6 months.You have a heart condition that affects how your heart works.You have a tumor in the middle of your chest near the structures that connect to your lungs.
Research Study Groups:
This trial has the following groups:- Group 1: Imatinib oral100mg tablets
Awards:
This trial has 3 awards, including:- Approved for 20 Other Conditions - This treatment demonstrated efficacy for 20 other conditions.
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
What potential risks do Imatinib Oral Tablet present for human health?
"Imatinib Oral Tablet has only been tested in a Phase 1 trial, and thus received a score of one due to the lack of evidence for both safety and efficacy."
Answered by AI
What medical ailments is Imatinib Oral Tablet used to treat?
"Imatinib Oral Tablet is the primary prescribed treatment for newly diagnosed cases of acute lymphoblastic leukaemia. Additionally, it has been shown to have efficacy in managing refractory ALL, myelodysplastic syndrome, and metastatic dermatofibrosarcoma protuberans."
Answered by AI
Is enrollment currently open for the trial?
"The clinical trial is presently in search of participants, as indicated by the data uploaded to clinicaltrials.gov. The original post for this medical study went up on September 18th 2018 and was last updated February 1st 2021"
Answered by AI
How many participants have been signed up for this research endeavor?
"Correct. Data hosted on clinicaltrials.gov reveals that this medical research, which was launched on September 18th 2018, is actively recruiting participants. A total of 18 patients need to be sourced from one particular site."
Answered by AI
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