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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up number of deaths since randomisation
Awards & highlights

Study 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.Check my eligibility
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.See study design
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
Select...
My thyroid cancer cannot be removed by surgery and has spread.
Select...
My tumor can be measured.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Progression-Free Survival(PFS)
Secondary outcome measures
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%
Electrocardiogram QT prolonged
17%
Constipation
15%
Back pain
15%
Gynaecomastia
10%
Photosensitivity reaction
10%
Dizziness
10%
Weight decreased
8%
Dry Skin
8%
Cough
8%
Rash
8%
Abdominal pain
8%
Insomnia
8%
Urinary tra ct infection
8%
Depression
8%
Pruritus
8%
Cytolytic hepatitis
6%
Erythema
6%
Skin fissures
6%
Epistaxis
6%
Arthralgia
6%
Abdominal pain upper
6%
Musculoskeletal pain
6%
Headache
6%
Sciatica
6%
Rash erythematous
4%
Myalgia
4%
Haematuria
4%
Bone pain
4%
Pollakiuria
4%
Anxiety
4%
Fatigue
4%
Cerebrovascular accident
2%
Death
2%
Ventricular extrasystoles
2%
Hypertensive crisis
2%
Pneumonia
2%
Spondylitis
2%
Torsade de pointes
2%
Dysuria
2%
Pain in extremity
2%
Sepsis
2%
Rhinitis
2%
Pulmonary embolism
2%
Drug eruption
2%
Toxic skin eruption
2%
Anal fissure
2%
Bronchopneumonia
2%
Chronic lymphocytic leukaemia
2%
Anaemia
2%
Disease progression
2%
Ileus
2%
Cerebral haemorrhage
2%
Stent placement
2%
Performance status decrease
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vandetanib
Placebo

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
524 Previous Clinical Trials
85,193 Total Patients Enrolled
Clinical Sciences & OperationsStudy DirectorSanofi
857 Previous Clinical Trials
2,018,862 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people are participating in this clinical trial?

"Unfortunately, this study is no longer enrolling patients. The trial was initially posted on 2006-11-30 and was last updated on 2022-10-03. However, there are other ongoing trials that may be of interest. There are 306 clinical studies currently recruiting patients with carcinoma and neuroendocrine cancers. Additionally, there are 12 ZD6474 (Vandetanib) trials looking for participants."

Answered by AI

Are there any current openings for participants in this research project?

"This study has completed recruitment for volunteers. The trial was first posted on 11/30/2006 and was last edited on 10/3/2022. However, there are other ongoing studies which might be of interest. As of now, 306 trials are actively enrolling participants with carcinoma, neuroendocrine and 12 trials for ZD6474 (Vandetanib) are admitting patients."

Answered by AI

To your knowledge, is this the first time this type of trial has been conducted?

"As of now, there are 12 ongoing clinical trials for the drug ZD6474 (Vandetanib) in 153 cities and 42 countries. The first trial for this medication was held back in 2006. That initial study, which was sponsored by Genzyme (a Sanofi Company), involved 437 patients and completed its Phase 3 drug approval stage. In the 14 years since 2006, an additional 57 trials have been conducted."

Answered by AI

What is the most recent decision by the FDA concerning ZD6474 (Vandetanib)?

"ZD6474 (Vandetanib) has been deemed safe by our team at Power, who gave it a score of 3. This is due to the fact that this Phase 3 trial has shown some efficacy in past patients, as well as multiple rounds of supportive data."

Answered by AI

What are some other circumstances in which ZD6474 (Vandetanib) has been tested?

"ZD6474 (Vandetanib) was first studied in 2006 at site number 2. Since then, there have been 57 completed trials with 12 ongoing studies. Many of the active clinical trials are being conducted out of Detroit, Michigan."

Answered by AI

By how many different organizations is this research project being overseen?

"If you're looking to enroll in this study, know that there are 21 different recruitment sites. These locations include Detroit, Houston, Calgary and 18 additional cities. To cut down on travel, try and choose the site closest to your residence."

Answered by AI
~24 spots leftby Apr 2025