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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 3 to week 60 (maximum)

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 3 to week 60 (maximum)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 3 to week 60 (maximum)

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 3 to week 60 (maximum) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Overall Response Rate (ORR) for Vandetanib 150 and 300mg With Responses Determined by the Investigator

Secondary outcome measures

Best Objective Response

Duration of Objective Response (RECIST 1.1) by Treatment Arm

Percentage Change From Baseline in Target Lesion Size (RECIST 1.1) by Treatment Arm

+2 more

Trial Design

2Treatment groups

Active Control

Group I: 150mg vandetanibActive Control1 Intervention

Group II: 300mg vandetanibActive Control1 Intervention

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Genzyme, a Sanofi CompanyLead Sponsor

524 Previous Clinical Trials

85,548 Total Patients Enrolled

Clinical Sciences & OperationsStudy ChairSanofi

863 Previous Clinical Trials

2,020,087 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

Frequently Asked Questions

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

Is the recruitment process for this trial currently open to participants?

"This research study is not currently recruiting. Having been initially posted on August 28th 2012, with the most recent revision made October 3rd 2022, there are other trials that prospective participants may wish to consider; 230 clinical studies for thyroid cancer and 11 investigations centering around 300mg vandetanib have openings at this time."

Answered by AI

Is this initiative pioneering in its approach?

"The research for 300mg vandetanib began in 2006, when Genzyme, a Sanofi Company sponsored the first study with 437 participants. Subsequently, Phase 3 drug approval was granted and now there are 11 active trials spanning 153 cities across 42 countries that seek to further explore its medical implications."

Answered by AI

What is the cap for patient participation in this clinical research?

"Currently, this clinical trial is not recruiting any new patients. Initially posted on August 28th 2012 and last updated October 3rd 2022, persons seeking to take part in a medical study should consider the 230 trials which are presently accepting participants with thyroid cancer or alternatively look into one of 11 studies looking for volunteers taking 300mg vandetanib."

Answered by AI