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Tyrosine Kinase Inhibitor
Vandetanib Dosing for Thyroid Cancer
Phase 4
Waitlist Available
Research Sponsored by Genzyme, a Sanofi Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
World Health Organisation (WHO) or Eastern Cooperative Oncology Group (ECOG) Performance status 0-2
Previously confirmed histological diagnosis of unresectable, locally advanced or metastatic, hereditary or sporadic MTC
Must not have
Significant cardiac conditions or events such as reduced cardiac functions, symptomatic cardiac arrhythmia requiring treatment, congenital long QT syndrome, history of drug-induced QT prolongation, or QTcF correction unmeasurable or more than 450 ms
For women only - currently pregnant or breast feeding
Timeline
Screening 3 weeks
Treatment Varies
Follow Up randomisation to week 60 (maximum)
Awards & highlights
Summary
This trial is testing two different doses of vandetanib for patients with medullary thyroid cancer. The goal is to see how well each dose affects the cancer and what side effects result from each.
Who is the study for?
This trial is for adults over 18 with advanced medullary thyroid cancer that can't be removed by surgery or has spread. They must have had recent cancer progression or symptoms, measurable disease, and a performance status of 0-2. Those who've had recent treatments, abnormal liver tests, significant heart issues, electrolyte imbalances, or decreased kidney function cannot join.
What is being tested?
The study compares the effects of two doses of vandetanib (150mg/day vs. 300mg/day) on patients with advanced medullary thyroid cancer to see which dose better controls the disease and to understand different side effects at these doses.
What are the potential side effects?
Vandetanib may cause side effects like rash, diarrhea, high blood pressure, headache, fatigue, and stomach pain. It might also affect heart rhythm and could lead to serious conditions if not monitored.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself and perform daily activities.
Select...
My medullary thyroid cancer cannot be surgically removed and has spread.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have serious heart conditions like arrhythmia or long QT syndrome.
Select...
I am currently pregnant or breastfeeding.
Select...
My blood tests show abnormal levels of potassium, magnesium, calcium, or my kidneys are not working well.
Select...
My liver tests are abnormal, possibly due to my cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ randomisation to week 60 (maximum)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~randomisation to week 60 (maximum)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Overall Response Rate (ORR) for Vandetanib 150 and 300mg With Responses Determined by the Investigator
Trial Design
2Treatment groups
Active Control
Group I: 150mg vandetanibActive Control1 Intervention
Group II: 300mg vandetanibActive Control1 Intervention
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Who is running the clinical trial?
Genzyme, a Sanofi CompanyLead Sponsor
526 Previous Clinical Trials
260,539 Total Patients Enrolled
Clinical Sciences & OperationsStudy ChairSanofi
869 Previous Clinical Trials
2,020,551 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- The lesions can be accurately measured multiple times.I haven't had surgery, radiation, chemotherapy, or experimental drugs in the last 28 days.I do not have serious heart conditions like arrhythmia or long QT syndrome.I am 18 or older and have given my written consent.My cancer has worsened in the last 14 months or I have symptoms related to my MTC.I have a tumor that can be measured and hasn't been treated with radiation in the last 3 months.I am currently pregnant or breastfeeding.My blood tests show abnormal levels of potassium, magnesium, calcium, or my kidneys are not working well.I can take care of myself and perform daily activities.My liver tests are abnormal, possibly due to my cancer.My medullary thyroid cancer cannot be surgically removed and has spread.
Research Study Groups:
This trial has the following groups:- Group 1: 150mg vandetanib
- Group 2: 300mg vandetanib
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- 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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