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Tyrosine Kinase Inhibitor

Vandetanib (SAR390530) for Thyroid Cancer (VERIFY Trial)

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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up patient assessments at baseline, week 4, 8, 12 and then every 12 weeks thereafter, assess up to 25.5 months
Awards & highlights

VERIFY Trial Summary

This trial is looking at whether vandetanib is more effective than placebo at treating people with thyroid cancer that has spread and is resistant or unable to be treated with radioiodine therapy. Secondary objectives include evaluating vandetanib's effects on tumor size, overall survival, pain, and safety.

Eligible Conditions
  • Thyroid Cancer

VERIFY Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~patient assessments at baseline, week 4, 8, 12 and then every 12 weeks thereafter, assess up to 25.5 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and patient assessments at baseline, week 4, 8, 12 and then every 12 weeks thereafter, assess up to 25.5 months 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
Demonstration of an Improvement in Time to Worsening of Pain in Patients Treated With Vandetanib When Compared to Placebo in the Patient Population.
Determination of the Efficacy of Vandetanib When Compared to Placebo in the Patient Population as Assessed by Efficacy Variables Including Change in Tumour Size
Determination of the Efficacy of Vandetanib When Compared to Placebo in the Patient Population as Assessed by Efficacy Variables Including Duration of Response.
+7 more

Side effects data

From 2022 Phase 3 trial • 243 Patients • NCT01876784
67%
Diarrhoea
40%
Hypertension
34%
Rash
29%
Electrocardiogram QT prolonged
16%
Asthenia
16%
Decreased appetite
15%
Nausea
14%
Alanine aminotransferase increased
13%
Aspartate aminotransferase increased
13%
Dry skin
13%
Insomnia
12%
Hypocalcaemia
11%
Photosensitivity reaction
11%
Fatigue
10%
Headache
10%
Dermatitis acneiform
9%
Cough
8%
Acne
8%
Constipation
8%
Urinary tract infection
8%
Vomiting
8%
Hypokalaemia
8%
Hypomagnesaemia
7%
Abdominal pain
7%
Weight decreased
6%
Blood creatinine increased
6%
Nasopharyngitis
6%
Pruritus
6%
Rash maculo-papular
6%
Arthralgia
6%
Musculoskeletal chest pain
6%
Proteinuria
5%
Stomatitis
5%
Palmar-plantar erythrodysaesthesia syndrome
5%
Erythema
5%
Keratopathy
5%
Dyspepsia
4%
Dyspnoea
4%
Back pain
4%
Pyrexia
3%
Haemoptysis
3%
Upper respiratory tract infection
3%
Oropharyngeal pain
3%
Pneumonia
2%
Respiratory failure
2%
Anaemia
2%
Lung infection
1%
Pneumothorax
1%
Bladder cancer
1%
Viral upper respiratory tract infection
1%
Cerebrovascular accident
1%
Dizziness
1%
Interstitial lung disease
1%
Pulmonary embolism
1%
Pathological fracture
1%
Multi-organ failure
1%
Troponin increased
1%
Post procedural haemorrhage
1%
Large intestine polyp
1%
Stevens-Johnson syndrome
1%
Thrombocytopenia
1%
Inappropriate antidiuretic hormone secretion
1%
Generalised tonic-clonic seizure
1%
Pleural effusion
1%
Pneumonia aspiration
1%
Respiratory tract infection
1%
Sepsis
1%
Cardiac arrest
1%
Ventricular extrasystoles
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vandetanib
Placebo

VERIFY Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: VandetanibExperimental Treatment1 Intervention
Vandetanib 300 mg tablet, orally once daily until disease progression or death.
Group II: PlaceboPlacebo Group1 Intervention
Placebo matched to vandetanib tablet, orally once daily until disease progression or death.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vandetanib (SAR390530)
2013
Completed Phase 3
~250

Find a Location

Who is running the clinical trial?

Genzyme, a Sanofi CompanyLead Sponsor
524 Previous Clinical Trials
85,387 Total Patients Enrolled
Clinical Sciences & OperationsStudy DirectorSanofi
862 Previous Clinical Trials
2,019,596 Total Patients Enrolled

Frequently Asked Questions

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

When was Vandetanib (SAR390530) cleared by the FDA?

"Vandetanib (SAR390530) is a Phase 3 trial medication, meaning that there is available data which supports both efficacy and safety. Consequently, our team at Power has given it a rating of 3 for safety."

Answered by AI

Yes, there are several clinics running this clinical trial in Canada.

"Enrolment for this clinical trial is currently underway at 10 sites. These locations include Little Rock, Ann Arbor, and Saint Louis. If you are interested in enrolling, please select the site nearest to you to limit travel."

Answered by AI

Are there any other existing reports on Vandetanib (SAR390530) from previous clinical trials?

"The drug vandetanib (SAR390530), was first trialed in 2006 at Investigational Site Number 2802. Out of the 18,291 completed studies, 12 are active, with a notable concentration in Little Rock, Arkansas."

Answered by AI

Do we still need participants for this clinical trial?

"This trial is not currently recruiting patients but was most recently updated on October 20th, 2021. If you are seeking other studies, 236 studies are actively recruiting patients with thyroid adenoma and 12 trials for Vandetanib (SAR390530) are actively recruiting patients."

Answered by AI

Have other researchers conducted a similar study before?

"Vandetanib (SAR390530) is being studied in 12 separate ongoing trials, which are taking place in 153 cities and 42 countries. The first study for Vandetanib (SAR390530) was conducted in 2006. It reached Phase 3 drug approval stage after 437 participants were involved. Since 2006, a total of 18291 trials have been conducted."

Answered by AI

How many people can be a part of this clinical trial at one time?

"236 other trials are actively searching for patients with thyroid adenoma. As for Vandetanib (SAR390530), 12 other trials are recruiting. This specific trial is no longer active, with the last update to the study occurring on October 20th, 2021."

Answered by AI
~21 spots leftby Apr 2025