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Tyrosine Kinase Inhibitor

Vandetanib for Thyroid Cancer

Phase 3
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
Confirmed diagnosis of unresectable, locally advanced or metastatic hereditary or sporadic Medullary Thyroid Cancer
Presence of measurable tumor
Must not have
Major surgery within 4 weeks before randomization
Previous ZD6474 treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up number of deaths since randomisation
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial is investigating the effects of the drug ZD6474 on patients with medullary thyroid cancer, in order to learn more about the drug's efficacy, side effects, and how it works in the human body.

Who is the study for?
This trial is for people with advanced or metastatic hereditary or sporadic medullary thyroid cancer that can't be removed by surgery. Participants must have tumors that can be measured and should be able to take oral medication. They shouldn't have had major surgery, chemotherapy, radiation therapy (except palliative care), or treatment with ZD6474 recently.
What is being tested?
The study tests the effects of ZD6474 (Vandetanib) on patients with medullary thyroid cancer. It aims to understand how patients respond to the drug, its side effects, how it's processed in the body, and if it can slow down or stop tumor growth.
What are the potential side effects?
Possible side effects of ZD6474 include diarrhea, rash, nausea, high blood pressure, headache, fatigue and stomach pain. Some may experience changes in heart rhythm or other serious conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My thyroid cancer cannot be removed by surgery and has spread.
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My tumor can be measured.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have not had major surgery in the last 4 weeks.
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I have been treated with ZD6474 before.
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I haven't had radiation therapy in the last 4 weeks, except for palliative care.
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I received my last chemotherapy dose less than 4 weeks ago.
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I have had major heart problems.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~blood samples for analysis of cea were taken at screening baseline (average of 0, 1, 4 and 8 hours), then every 4 weeks until discontinuation and 60 day follow up
This trial's timeline: 3 weeks for screening, Varies for treatment, and blood samples for analysis of cea were taken at screening baseline (average of 0, 1, 4 and 8 hours), then every 4 weeks until discontinuation and 60 day follow up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Progression-Free Survival(PFS)
Secondary study objectives
Biochemical Response Calcitonin (CTN)
Carcinoembryonic Antigen
Disease Control Rate (DCR)
+4 more

Side effects data

From 2011 Phase 2 trial • 95 Patients • NCT00659438
44%
Diarrhoea
42%
Asthenia
29%
Hypertension
23%
Hot flush
19%
Nausea
17%
Constipation
17%
Electrocardiogram QT prolonged
15%
Gynaecomastia
15%
Back pain
10%
Photosensitivity reaction
10%
Dizziness
10%
Weight decreased
8%
Abdominal pain
8%
Cough
8%
Rash
8%
Insomnia
8%
Dry Skin
8%
Urinary tra ct infection
8%
Depression
8%
Pruritus
8%
Cytolytic hepatitis
6%
Abdominal pain upper
6%
Arthralgia
6%
Epistaxis
6%
Erythema
6%
Skin fissures
6%
Musculoskeletal pain
6%
Headache
6%
Sciatica
6%
Rash erythematous
4%
Anxiety
4%
Myalgia
4%
Bone pain
4%
Pollakiuria
4%
Haematuria
4%
Fatigue
4%
Cerebrovascular accident
2%
Pneumonia
2%
Spondylitis
2%
Pain in extremity
2%
Death
2%
Ileus
2%
Torsade de pointes
2%
Anaemia
2%
Hypertensive crisis
2%
Ventricular extrasystoles
2%
Chronic lymphocytic leukaemia
2%
Dysuria
2%
Sepsis
2%
Rhinitis
2%
Pulmonary embolism
2%
Drug eruption
2%
Toxic skin eruption
2%
Anal fissure
2%
Bronchopneumonia
2%
Disease progression
2%
Cerebral haemorrhage
2%
Stent placement
2%
Performance status decrease
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vandetanib
Placebo

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: 2Experimental Treatment1 Intervention
Vandetanib
Group II: 1Active Control1 Intervention
Placebo vandetanib
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ZD6474 (Vandetanib)
2008
Completed Phase 2
~210

Find a Location

Who is running the clinical trial?

Genzyme, a Sanofi CompanyLead Sponsor
527 Previous Clinical Trials
185,313 Total Patients Enrolled
Clinical Sciences & OperationsStudy DirectorSanofi
877 Previous Clinical Trials
2,022,379 Total Patients Enrolled

Media Library

ZD6474 (Vandetanib) (Tyrosine Kinase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT00410761 — Phase 3
Thyroid Cancer Research Study Groups: 1, 2
Thyroid Cancer Clinical Trial 2023: ZD6474 (Vandetanib) Highlights & Side Effects. Trial Name: NCT00410761 — Phase 3
ZD6474 (Vandetanib) (Tyrosine Kinase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00410761 — Phase 3
~23 spots leftby Dec 2025
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