Study to Determine if Contacting Patients With MTC More Frequently Results in Earlier Detection and Treatment of Signs and Symptoms of AEs and Thus a Decrease in the Percentage of Time Patients Experience AEs During First 12 Months on Vandetanib Treatment (88)
Primary Purpose
Locally Advanced or Metastatic Medullary Thyroid Cancer, Medullary Thyroid Cancer
Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Patient outreach
Vandetanib
Sponsored by
About this trial
This is an interventional treatment trial for Locally Advanced or Metastatic Medullary Thyroid Cancer focused on measuring Medullary Thyroid Cancer, Locally advanced, Metastatic, Vandetanib, Patient Outreach
Eligibility Criteria
Inclusion Criteria:
- Provision of informed consent prior to any study specific procedures
- Female or male aged 18 years and over
- 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
- Negative pregnancy test (urine or serum) for female patients of childbearing potential
Exclusion Criteria:
- Unstable brain metastases or spinal cord compression that require treatment, unless treated at least 4 weeks before first dose and stable without steroid treatment for 10 days
- Major surgery within 4 weeks before randomization
- The last dose of prior chemotherapy received less than 3 weeks prior to randomization
- Radiation therapy not completed prior to the first dose of vandetanib
- Significant cardiac event, superior vena cava syndrome, NYHA classification of heart disease ≥2, within 12 weeks before randomization, or presence of cardiac disease that in the opinion of the Investigator increases risk of ventricular arrhythmia
- Creatinine clearance <30 ml/min (calculated by Cockcroft-Gault formula),Patients with moderate renal impairment, defined as creatinine clearance ≥30 to <50 ml/min, must start vandetanib at a reduced dose of 200 mg
Sites / Locations
- Investigational Site Number 301
- Investigational Site Number 401
- Investigational Site Number 501
- Investigational Site Number 701
- Investigational Site Number 702
- Investigational Site Number 901
- Investigational Site Number 1001
- Investigational Site Number 1002
- Investigational Site Number 1003
- Investigational Site Number 1301
- Investigational Site Number 1302
- Investigational Site Number 1901
- Investigational Site Number 2001
- Investigational Site Number 2201
- Investigational Site Number 2602
- Investigational Site Number 2603
- Investigational Site Number 2601
- Investigational Site Number 3001
- Investigational Site Number 3501
- Investigational Site Number 3502
- Investigational Site Number 4001
- Investigational Site Number 4104
- Investigational Site Number 4101
- Investigational Site Number 4102
- Investigational Site Number 6001
- Investigational Site Number 5702
- Investigational Site Number 5703
- Investigational Site Number 6201
- Investigational Site Number 6204
- Investigational Site Number 6202
- Investigational Site Number 6203
- Investigational Site Number 7201
- Investigational Site Number 2802
- Investigational Site Number 2801
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Vandetanib Control
Experimental
Arm Description
Control - treatment 300mg vandetanib opel label
Experimental - treatment 300mg vandetanib opel label
Outcomes
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.
The primary endpoint is the percentage of time a patient experienced at least one AE of CTCAE grade 2 or higher in the first 12 months of treatment with vandetanib. If the patient discontinues treatment with vandetanib prior to the 12-month time point for any reason, this endpoint will be the time a patient experienced at least one AE of CTCAE grade 2 or higher as a percentage of the time the patient was receiving vandetanib.
Secondary Outcome Measures
Full Information
NCT ID
NCT01298323
First Posted
February 16, 2011
Last Updated
September 22, 2023
Sponsor
Genzyme, a Sanofi Company
1. Study Identification
Unique Protocol Identification Number
NCT01298323
Brief Title
Study to Determine if Contacting Patients With MTC More Frequently Results in Earlier Detection and Treatment of Signs and Symptoms of AEs and Thus a Decrease in the Percentage of Time Patients Experience AEs During First 12 Months on Vandetanib Treatment
Acronym
88
Official Title
A Randomized,Int.,Open-Label Phase III Study to Assess the Effect of a Patient Outreach Program on the Percentage of Time Patients With Locally Advanced or Metastatic MTC Experience Grade 2 or Higher AEs in the First 12 Months of Treatment With Vandetanib
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 25, 2011 (Actual)
Primary Completion Date
April 26, 2013 (Actual)
Study Completion Date
June 28, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genzyme, a Sanofi Company
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to evaluate the effect of patient outreach program on the proportion of time patients with MTC experience moderate or severe AEs during first 12 months of treatment with vandetanib
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Locally Advanced or Metastatic Medullary Thyroid Cancer, Medullary Thyroid Cancer
Keywords
Medullary Thyroid Cancer, Locally advanced, Metastatic, Vandetanib, Patient Outreach
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
205 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vandetanib Control
Arm Type
Active Comparator
Arm Description
Control - treatment 300mg vandetanib opel label
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Experimental - treatment 300mg vandetanib opel label
Intervention Type
Behavioral
Intervention Name(s)
Patient outreach
Intervention Description
Patients will be contacted at week 1 and then every 2 weeks until completion of 52 weeks to detect/treat AEs sooner
Intervention Type
Drug
Intervention Name(s)
Vandetanib
Other Intervention Name(s)
SAR390530
Intervention Description
Treatment 300mg vandetanib opel label.
Primary Outcome Measure Information:
Title
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.
Description
The primary endpoint is the percentage of time a patient experienced at least one AE of CTCAE grade 2 or higher in the first 12 months of treatment with vandetanib. If the patient discontinues treatment with vandetanib prior to the 12-month time point for any reason, this endpoint will be the time a patient experienced at least one AE of CTCAE grade 2 or higher as a percentage of the time the patient was receiving vandetanib.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Provision of informed consent prior to any study specific procedures
Female or male aged 18 years and over
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
Negative pregnancy test (urine or serum) for female patients of childbearing potential
Exclusion Criteria:
Unstable brain metastases or spinal cord compression that require treatment, unless treated at least 4 weeks before first dose and stable without steroid treatment for 10 days
Major surgery within 4 weeks before randomization
The last dose of prior chemotherapy received less than 3 weeks prior to randomization
Radiation therapy not completed prior to the first dose of vandetanib
Significant cardiac event, superior vena cava syndrome, NYHA classification of heart disease ≥2, within 12 weeks before randomization, or presence of cardiac disease that in the opinion of the Investigator increases risk of ventricular arrhythmia
Creatinine clearance <30 ml/min (calculated by Cockcroft-Gault formula),Patients with moderate renal impairment, defined as creatinine clearance ≥30 to <50 ml/min, must start vandetanib at a reduced dose of 200 mg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number 301
City
St Leonards
ZIP/Postal Code
2065
Country
Australia
Facility Name
Investigational Site Number 401
City
Wien
ZIP/Postal Code
1901
Country
Austria
Facility Name
Investigational Site Number 501
City
Bruxelles
ZIP/Postal Code
1000
Country
Belgium
Facility Name
Investigational Site Number 701
City
Porto Alegre
ZIP/Postal Code
90035-003
Country
Brazil
Facility Name
Investigational Site Number 702
City
Ribeirão Preto
ZIP/Postal Code
14048-900
Country
Brazil
Facility Name
Investigational Site Number 901
City
Sofia
ZIP/Postal Code
1527
Country
Bulgaria
Facility Name
Investigational Site Number 1001
City
London
ZIP/Postal Code
N6A 4L6
Country
Canada
Facility Name
Investigational Site Number 1002
City
Sherbrooke
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Investigational Site Number 1003
City
Toronto
ZIP/Postal Code
M5G2M9
Country
Canada
Facility Name
Investigational Site Number 1301
City
Beijing
ZIP/Postal Code
100021
Country
China
Facility Name
Investigational Site Number 1302
City
Shanghai
Country
China
Facility Name
Investigational Site Number 1901
City
Praha
ZIP/Postal Code
15006
Country
Czechia
Facility Name
Investigational Site Number 2001
City
Odense C
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Investigational Site Number 2201
City
Helsinki
ZIP/Postal Code
FI-00029
Country
Finland
Facility Name
Investigational Site Number 2602
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Investigational Site Number 2603
City
Halle
ZIP/Postal Code
06120
Country
Germany
Facility Name
Investigational Site Number 2601
City
Würzburg
ZIP/Postal Code
97080
Country
Germany
Facility Name
Investigational Site Number 3001
City
Athens
ZIP/Postal Code
11528
Country
Greece
Facility Name
Investigational Site Number 3501
City
Mumbai
ZIP/Postal Code
400012
Country
India
Facility Name
Investigational Site Number 3502
City
Vellore
ZIP/Postal Code
632004
Country
India
Facility Name
Investigational Site Number 4001
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Investigational Site Number 4104
City
Napoli
Country
Italy
Facility Name
Investigational Site Number 4101
City
Pisa
ZIP/Postal Code
56124
Country
Italy
Facility Name
Investigational Site Number 4102
City
Roma
ZIP/Postal Code
00161
Country
Italy
Facility Name
Investigational Site Number 6001
City
Seoul
Country
Korea, Republic of
Facility Name
Investigational Site Number 5702
City
Poznan
ZIP/Postal Code
60-355
Country
Poland
Facility Name
Investigational Site Number 5703
City
Warsaw
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Investigational Site Number 6201
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Investigational Site Number 6204
City
Moscow
ZIP/Postal Code
125284
Country
Russian Federation
Facility Name
Investigational Site Number 6202
City
Obninsk
ZIP/Postal Code
249036
Country
Russian Federation
Facility Name
Investigational Site Number 6203
City
St Petersburg
ZIP/Postal Code
197022
Country
Russian Federation
Facility Name
Investigational Site Number 7201
City
Uppsala
ZIP/Postal Code
75185
Country
Sweden
Facility Name
Investigational Site Number 2802
City
Glasgow
ZIP/Postal Code
G120YN
Country
United Kingdom
Facility Name
Investigational Site Number 2801
City
Sutton
ZIP/Postal Code
SM25PT
Country
United Kingdom
12. IPD Sharing Statement
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=1433&filename=D4200C00088_Study_Synopsis.pdf
Description
D4200C00088_CSR_Synopsis
Learn more about this trial
Study to Determine if Contacting Patients With MTC More Frequently Results in Earlier Detection and Treatment of Signs and Symptoms of AEs and Thus a Decrease in the Percentage of Time Patients Experience AEs During First 12 Months on Vandetanib Treatment
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