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To Compare The Effects Of Two Doses Of Vandetanib In Patients With Advanced Medullary Thyroid Cancer

Primary Purpose

Thyroid Cancer

Status
Active
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
300mg vandetanib
150mg vandetanib
Sponsored by
Genzyme, a Sanofi Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thyroid Cancer focused on measuring medullary thyroid cancer, metastatic, thyroid cancer, carcinoma of the thyroid, receptor tyrosine kinase inhibitor, VEGFR, Unresectable locally advanced thyroid cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Written consent from Female or male patients aged 18 years and over. Previously confirmed histological diagnosis of unresectable, locally advanced or metastatic, hereditary or sporadic MTC Objective disease progression within the previous 14 months prior to enrolment, and/or
  • Have one or more symptoms that the Investigator believes to be related to the patient's MTC.
  • World Health Organisation (WHO) or Eastern Cooperative Oncology Group (ECOG) Performance status 0-2.
  • Has measurable disease (at least one lesion, not irradiated within 12 weeks of study randomisation, with longest diameter more or equal 10mm (lymph nodes minimum more or equal 15 mm) with CT or MRI).
  • Lesions must be amenable to accurate and repeat measurement.

Exclusion Criteria:

  • Prior treatment (major surgery, radiation therapy, chemotherapy, or other investigational drugs) received within 28 days before randomization.
  • Abnormal liver function tests (bilirubin more than 1.5xULRR, and ALT, AST, or ALP more than 2.5xULRR or 5.0xULRR if related to liver metastases).
  • Significant cardiac conditions or events such as reduced cardiac functions, symptomatic cardiac arrhythmia requiring treatment, congenital long QT syndrome, history of drug-induced QT prolongation, or QTcF correction unmeasurable or more than 450 ms.
  • Abnormal electrolytes such as potassium, magnesium and calcium, or abnormal organ functions such as decreased creatinine clearance.
  • For women only - currently pregnant or breast feeding.

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

300mg vandetanib

150mg vandetanib

Arm Description

Outcomes

Primary Outcome Measures

Overall Response Rate (ORR) for Vandetanib 150 and 300mg With Responses Determined by the Investigator
ORR=proportion of patients with a best response of complete or partial response as per Response Evaluation Criteria in Solid Tumors(RECIST)1.1

Secondary Outcome Measures

Best Objective Response
Duration of Objective Response (RECIST 1.1) by Treatment Arm
Time to Objective Response (RECIST 1.1) by Treatment Arm
Percentage Change From Baseline in Target Lesion Size (RECIST 1.1) by Treatment Arm
Plasma Concentration of Vandetanib in the Bloodstream (Cmax) for Patients by Treatment Arm.

Full Information

First Posted
December 2, 2011
Last Updated
September 22, 2023
Sponsor
Genzyme, a Sanofi Company
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1. Study Identification

Unique Protocol Identification Number
NCT01496313
Brief Title
To Compare The Effects Of Two Doses Of Vandetanib In Patients With Advanced Medullary Thyroid Cancer
Official Title
An International, Randomised, Double-Blind, Two-Arm Study To Evaluate The Safety And Efficacy Of Vandetanib 150 And 300mg/Day In Patients With Unresectable Locally Advanced Or Metastatic Medullary Thyroid Carcinoma With Progressive Or Symptomatic Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 28, 2012 (Actual)
Primary Completion Date
April 2, 2014 (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 give patients with medullary thyroid cancer either 300mg/day or 150mg/day vandetanib and compare how well each dose affects how their cancer responds. It will also help the investigators understand the side effects of different doses in these patients.
Detailed Description
An International, Randomised, Double-Blind, Two-Arm Study To Evaluate The Safety And Efficacy Of Vandetanib 150 And 300mg/Day In Patients With Unresectable Locally Advanced Or Metastatic Medullary Thyroid Carcinoma With Progressive Or Symptomatic Disease

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Cancer
Keywords
medullary thyroid cancer, metastatic, thyroid cancer, carcinoma of the thyroid, receptor tyrosine kinase inhibitor, VEGFR, Unresectable locally advanced thyroid cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
81 (Actual)

8. Arms, Groups, and Interventions

Arm Title
300mg vandetanib
Arm Type
Active Comparator
Arm Title
150mg vandetanib
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
300mg vandetanib
Other Intervention Name(s)
SAR390530
Intervention Description
Oral blinded tablets taken once daily. At objective disease progression or 14 months (whichever is earlier), patient may be unblinded to treatment Dosing with unblinded study treatment can continue until 24 months after patient was randomised. At any time dosing may be interrupted for up to 6 weeks due to toxicity. Dosing may restart at a reduced dose (200mg/day). Once reduced, dose increases are not permitted and dosing must stop if further toxicities occur.
Intervention Type
Drug
Intervention Name(s)
150mg vandetanib
Other Intervention Name(s)
SAR390530
Intervention Description
Oral blinded tablets taken once daily. At objective disease progression or 14 months (whichever is earlier), patient may be unblinded to treatment. Patients who have not dose reduced at the time of unblinding may have their dose increased to 300mg Dosing with unblinded study treatment can continue until 24 months after patient was randomised At any time dosing may be interrupted for up to 6 weeks due to toxicity. Dosing may restart at a reduced dose (100mg/day) [OR 300 reduced to 200mg/day if dose was increased at unblinding.] Once reduced, dose increases are not permitted and dosing must stop if further toxicities occur.
Primary Outcome Measure Information:
Title
Overall Response Rate (ORR) for Vandetanib 150 and 300mg With Responses Determined by the Investigator
Description
ORR=proportion of patients with a best response of complete or partial response as per Response Evaluation Criteria in Solid Tumors(RECIST)1.1
Time Frame
Randomisation to week 60 (maximum)
Secondary Outcome Measure Information:
Title
Best Objective Response
Time Frame
Randomisation to week 60 (maximum)
Title
Duration of Objective Response (RECIST 1.1) by Treatment Arm
Time Frame
Randomization to Week 60 (maximum)
Title
Time to Objective Response (RECIST 1.1) by Treatment Arm
Time Frame
Randomization to Week 60 (maximum)
Title
Percentage Change From Baseline in Target Lesion Size (RECIST 1.1) by Treatment Arm
Time Frame
Randomization to Week 60 (maximum)
Title
Plasma Concentration of Vandetanib in the Bloodstream (Cmax) for Patients by Treatment Arm.
Time Frame
Week 3 to week 60 (maximum)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Written consent from Female or male patients aged 18 years and over. Previously confirmed histological diagnosis of unresectable, locally advanced or metastatic, hereditary or sporadic MTC Objective disease progression within the previous 14 months prior to enrolment, and/or Have one or more symptoms that the Investigator believes to be related to the patient's MTC. World Health Organisation (WHO) or Eastern Cooperative Oncology Group (ECOG) Performance status 0-2. Has measurable disease (at least one lesion, not irradiated within 12 weeks of study randomisation, with longest diameter more or equal 10mm (lymph nodes minimum more or equal 15 mm) with CT or MRI). Lesions must be amenable to accurate and repeat measurement. Exclusion Criteria: Prior treatment (major surgery, radiation therapy, chemotherapy, or other investigational drugs) received within 28 days before randomization. Abnormal liver function tests (bilirubin more than 1.5xULRR, and ALT, AST, or ALP more than 2.5xULRR or 5.0xULRR if related to liver metastases). Significant cardiac conditions or events such as reduced cardiac functions, symptomatic cardiac arrhythmia requiring treatment, congenital long QT syndrome, history of drug-induced QT prolongation, or QTcF correction unmeasurable or more than 450 ms. Abnormal electrolytes such as potassium, magnesium and calcium, or abnormal organ functions such as decreased creatinine clearance. For women only - currently pregnant or breast feeding.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Chair
Facility Information:
Facility Name
Research Site
City
Houston
State/Province
Texas
Country
United States
Facility Name
Research Site
City
Olomouc
Country
Czechia
Facility Name
Research Site
City
Praha 5
Country
Czechia
Facility Name
Research Site
City
Bangalore Karnataka
Country
India
Facility Name
Research Site
City
Vellore
Country
India
Facility Name
Research Site
City
Beer Sheva
Country
Israel
Facility Name
Research Site
City
Haifa
Country
Israel
Facility Name
Research Site
City
Jerusalem
Country
Israel
Facility Name
Research Site
City
Petach Tikva
Country
Israel
Facility Name
Research Site
City
Catania
Country
Italy
Facility Name
Research Site
City
Milano
Country
Italy
Facility Name
Research Site
City
Palermo
Country
Italy
Facility Name
Research Site
City
Pisa
Country
Italy
Facility Name
Research Site
City
Roma
Country
Italy
Facility Name
Research Site
City
Siena
Country
Italy
Facility Name
Research Site
City
Torino
Country
Italy
Facility Name
Research Site
City
Groningen
Country
Netherlands
Facility Name
Research Site
City
Leiden
Country
Netherlands
Facility Name
Research Site
City
Gliwice
Country
Poland
Facility Name
Research Site
City
Warszawa
Country
Poland
Facility Name
Research Site
City
Zgierz
Country
Poland
Facility Name
Research Site
City
Saint Petersburg
Country
Russian Federation
Facility Name
Research Site
City
Cardiff
Country
United Kingdom
Facility Name
Research Site
City
Greater London
Country
United Kingdom
Facility Name
Research Site
City
London
Country
United Kingdom
Facility Name
Research Site
City
Tyne & Wear
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=1434&filename=D4200C00097_Study_Synopsis.pdf
Description
D4200C00097_CSR_Synopsis.pdf

Learn more about this trial

To Compare The Effects Of Two Doses Of Vandetanib In Patients With Advanced Medullary Thyroid Cancer

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