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Tyrosine Kinase Inhibitor
Imatinib for Advanced Thyroid Cancer
Phase 1
Recruiting
Led By Todd McMullen
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
All Individual Drugs Already Approved
Approved for 20 Other Conditions
No Placebo-Only Group
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.
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.
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
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Restore iodine uptake
Secondary study objectives
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%
Hypotension
4%
Hypertension
4%
Intracranial hemorrhage
4%
Enterocolitis
2%
Small intestinal obstruction
2%
Lower gastrointestinal hemorrhage
2%
Fungemia
2%
Peripheral motor neuropathy
2%
Typhlitis
2%
Oropharyngeal pain
2%
Multi-organ failure
2%
Abdominal pain
2%
Hypoxia
2%
Kidney infection
2%
Edema limbs
2%
Sinus bradycardia
2%
Gastric hemorrhage
2%
Myocardial infarction
2%
Diarrhea
2%
Fibrinogen decreased
2%
Aspiration
2%
Atrial fibrillation
2%
Delirium
2%
Endophthalmitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Chemotherapy)
Awards & Highlights
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 20 Other Conditions
This treatment demonstrated efficacy for 20 other conditions.
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 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).
Find a Location
Who is running the clinical trial?
AHS Cancer Control AlbertaLead Sponsor
182 Previous Clinical Trials
26,813 Total Patients Enrolled
Alberta Cancer FoundationOTHER
17 Previous Clinical Trials
5,601 Total Patients Enrolled
Todd McMullenPrincipal InvestigatorAlberta Health services
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:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 20 Other Conditions - This treatment demonstrated efficacy for 20 other conditions.
- 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.
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