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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
Pivotal Trial
Drug Has Already Been Approved
No Placebo-Only Group

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 below
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I can take care of myself and perform daily activities.
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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:
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I do not have serious heart conditions like arrhythmia or long QT syndrome.
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I am currently pregnant or breastfeeding.
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My blood tests show abnormal levels of potassium, magnesium, calcium, or my kidneys are not working well.
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My liver tests are abnormal, possibly due to my cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~randomisation to week 60 (maximum)
This trial's timeline: 3 weeks for screening, Varies for treatment, and randomisation to week 60 (maximum) for reporting.

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

Awards & Highlights

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.

Trial Design

2Treatment groups
Active Control
Group I: 150mg vandetanibActive Control1 Intervention
Group II: 300mg vandetanibActive Control1 Intervention

Find a Location

Who is running the clinical trial?

Genzyme, a Sanofi CompanyLead Sponsor
527 Previous Clinical Trials
185,669 Total Patients Enrolled
Clinical Sciences & OperationsStudy ChairSanofi
877 Previous Clinical Trials
2,022,735 Total Patients Enrolled

Media Library

Vandetanib (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT01496313 — Phase 4
Thyroid Cancer Research Study Groups: 150mg vandetanib, 300mg vandetanib
Thyroid Cancer Clinical Trial 2023: Vandetanib Highlights & Side Effects. Trial Name: NCT01496313 — Phase 4
Vandetanib (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01496313 — Phase 4
~6 spots leftby Dec 2025
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