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Tyrosine Kinase Inhibitor
Patient Outreach Program for Medullary Thyroid Cancer (88 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
Previously confirmed histological diagnosis of unresectable, locally advanced or metastatic hereditary or sporadic MTC. Documentation must be provided in patient's medical chart
WHO or ECOG Performance status 0-2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
88 Trial Summary
This trial will test whether a patient outreach program can reduce the amount of time patients with MTC experience moderate or severe AEs while taking vandetanib.
Who is the study for?
This trial is for adults over 18 with advanced or metastatic Medullary Thyroid Cancer (MTC) that can't be surgically removed. Participants must have a confirmed diagnosis, be able to perform daily activities (with slight limitations at most), and not be pregnant. They shouldn't have unstable brain tumors, recent major surgery, chemotherapy within the last 3 weeks, incomplete radiation therapy before starting Vandetanib, severe kidney issues or heart disease.Check my eligibility
What is being tested?
The study tests if more frequent patient contact improves the management of side effects during the first year on Vandetanib for MTC. It aims to see if this approach reduces the time patients suffer from moderate or severe adverse events (AEs).See study design
What are the potential side effects?
Vandetanib may cause side effects like diarrhea, rash, nausea, high blood pressure and headache. Serious but less common side effects include heart rhythm problems and difficulty breathing.
88 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My medullary thyroid cancer cannot be surgically removed and is advanced.
Select...
I can take care of myself and perform daily activities.
88 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percentage of Time a Patient Experienced at Least 1 AE of CTCAE Grade >=2 in First 12 Months of Receiving Vandetanib in Patients Who Participated in Patient Outreach Program.
Side effects data
From 2014 Phase 3 trial • 1690 Patients • NCT0031237741%
Rash
41%
Diarrhoea
33%
Alopecia
31%
Neutropenia
30%
Fatigue
29%
Anorexia
23%
Nausea
19%
Cough
18%
Leukopenia
18%
Pyrexia
17%
Constipation
15%
Vomiting
15%
Dyspnoea
15%
Asthenia
14%
Insomnia
13%
Myalgia
12%
Stomatitis
10%
Anaemia
9%
Pruritus
9%
Arthralgia
8%
Headache
8%
Weight Decreased
7%
Nail Disorder
7%
Epistaxis
7%
Oedema Peripheral
7%
Mucosal Inflammation
7%
Back Pain
7%
Febrile Neutropenia
6%
Dysphonia
6%
Photosensitivity Reaction
6%
Dry Skin
6%
Hypertension
6%
Pain In Extremity
6%
Peripheral Sensory Neuropathy
6%
Paraesthesia
6%
Nasopharyngitis
6%
Abdominal Pain
6%
Dizziness
6%
Dysgeusia
5%
Pneumonia
5%
Haemoptysis
5%
Musculoskeletal Pain
5%
Dyspepsia
4%
Hiccups
4%
Abdominal Pain Upper
2%
Interstitial Lung Disease
1%
Gastroenteritis
1%
Lung Infection
1%
Urinary Tract Infection
1%
Convulsion
1%
Respiratory Failure
1%
Pneumonitis
1%
Pleural Effusion
1%
Toxic Epidermal Necrolysis
1%
Hypotension
1%
Respiratory Tract Infection
1%
Sepsis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Vandetanib 100 mg Plus Docetaxel
Placebo Plus Docetaxel
88 Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: ExperimentalExperimental Treatment2 Interventions
Experimental - treatment 300mg vandetanib opel label
Group II: Vandetanib ControlActive Control1 Intervention
Control - treatment 300mg vandetanib opel label
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vandetanib
2007
Completed Phase 3
~5640
Find a Location
Who is running the clinical trial?
Genzyme, a Sanofi CompanyLead Sponsor
524 Previous Clinical Trials
85,425 Total Patients Enrolled
Clinical Sciences & OperationsStudy DirectorSanofi
862 Previous Clinical Trials
2,019,634 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I received my last chemotherapy dose less than 3 weeks ago.I have not finished radiation therapy before starting vandetanib.I am 18 years old or older.My medullary thyroid cancer cannot be surgically removed and is advanced.My brain or spinal metastases are stable, treated over 4 weeks ago, and I've been off steroids for 10 days.Women who could become pregnant must have a negative pregnancy test.I can take care of myself and perform daily activities.I have not had a major heart event or disease that could increase my risk of irregular heartbeats in the last 3 months.My kidney function is reduced, with a creatinine clearance below 50 ml/min.I have not had major surgery in the last 4 weeks.
Research Study Groups:
This trial has the following groups:- Group 1: Vandetanib Control
- Group 2: Experimental
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any serious side effects associated with Vandetanib?
"Vandetanib has been determined to be safe by our team at Power. This is a Phase 3 medication, which means that not only is there some evidence of its efficacy, but that there have been multiple rounds of testing affirming its safety."
Answered by AI
Have there been other experiments like this in the past?
"Since 2006, Vandetanib has been under investigation in clinical trials. The first study, sponsored by Genzyme (a subsidiary of Sanofi), was completed in 2006 with 437 participants. After this initial study, Vandetanib went through Phase 3 drug approval and is now being studied in 12 active trials across 153 cities and 42 countries."
Answered by AI
Are patient volunteers still being taken for this research?
"No, this specific study is not currently looking for patients according to the data on clinicaltrials.gov. The study was first posted on February 25th, 2011 and was last updated on October 3rd, 2022. There are, however, 312 other studies that are actively recruiting patients."
Answered by AI
How many people are receiving help from this experiment?
"Unfortunately, this specific clinical trial is not currently enrolling patients. Although, if you are seeking other studies, there are presently 300 clinical trials actively looking for patients with thyroid adenoma and 12 studies for Vandetanib actively looking for patients."
Answered by AI
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