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

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ClinicalTrials.gov Identifier: NCT01496313

Recruitment Status : Active, not recruiting

First Posted : December 21, 2011

Results First Posted : November 27, 2015

Last Update Posted : November 14, 2016

Sponsor:

Information provided by (Responsible Party):

Sanofi ( Genzyme, a Sanofi Company )

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.

Condition or disease	Intervention/treatment	Phase
Thyroid Cancer	Drug: 300mg vandetanib Drug: 150mg vandetanib	Phase 4

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

Study Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	81 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Care Provider, Investigator)
Primary Purpose:	Treatment
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 Start Date :	June 2012
Actual Primary Completion Date :	April 2014
Estimated Study Completion Date :	December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thyroid Cancer Thyroid Diseases

Drug Information available for: Vandetanib

Genetic and Rare Diseases Information Center resources: Thyroid Cancer, Medullary

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 300mg vandetanib	Drug: 300mg vandetanib 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. Other Name: SAR390530
Active Comparator: 150mg vandetanib	Drug: 150mg vandetanib 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. Other Name: SAR390530

Arm

Intervention/treatment

Active Comparator: 300mg vandetanib

Drug: 300mg vandetanib

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.

Other Name: SAR390530

Active Comparator: 150mg vandetanib

Drug: 150mg vandetanib

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.

Other Name: SAR390530

Outcome Measures

Primary Outcome Measures :

Overall Response Rate (ORR) for Vandetanib 150 and 300mg With Responses Determined by the Investigator [ Time Frame: Randomisation to week 60 (maximum) ]
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 [ Time Frame: Randomisation to week 60 (maximum) ]
Duration of Objective Response (RECIST 1.1) by Treatment Arm [ Time Frame: Randomization to Week 60 (maximum) ]
Time to Objective Response (RECIST 1.1) by Treatment Arm [ Time Frame: Randomization to Week 60 (maximum) ]
Percentage Change From Baseline in Target Lesion Size (RECIST 1.1) by Treatment Arm [ Time Frame: Randomization to Week 60 (maximum) ]
Plasma Concentration of Vandetanib in the Bloodstream (Cmax) for Patients by Treatment Arm. [ Time Frame: Week 3 to week 60 (maximum) ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01496313

Locations


United States, Texas
Research Site
Houston, Texas, United States
Czech Republic
Research Site
Olomouc, Czech Republic
Research Site
Praha 5, Czech Republic
India
Research Site
Bangalore Karnataka, India
Research Site
Vellore, India
Israel
Research Site
Beer Sheva, Israel
Research Site
Haifa, Israel
Research Site
Jerusalem, Israel
Research Site
Petach Tikva, Israel
Italy
Research Site
Catania, Italy
Research Site
Milano, Italy
Research Site
Palermo, Italy
Research Site
Pisa, Italy
Research Site
Roma, Italy
Research Site
Siena, Italy
Research Site
Torino, Italy
Netherlands
Research Site
Groningen, Netherlands
Research Site
Leiden, Netherlands
Poland
Research Site
Gliwice, Poland
Research Site
Warszawa, Poland
Research Site
Zgierz, Poland
Russian Federation
Research Site
Saint Petersburg, Russian Federation
United Kingdom
Research Site
Cardiff, United Kingdom
Research Site
Greater London, United Kingdom
Research Site
London, United Kingdom
Research Site
Tyne & Wear, United Kingdom

Sponsors and Collaborators

Genzyme, a Sanofi Company

Investigators


Study Chair:	Clinical Sciences & Operations	Sanofi

More Information

Additional Information:

D4200C00097_CSR_Synopsis.pdf This link exits the ClinicalTrials.gov site


Responsible Party:	Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier:	NCT01496313 History of Changes
Other Study ID Numbers:	D4200C00097 2011-004701-24 ( EudraCT Number ) LPS14809 ( Other Identifier: Sanofi )
First Posted:	December 21, 2011 Key Record Dates
Results First Posted:	November 27, 2015
Last Update Posted:	November 14, 2016
Last Verified:	October 2016

Keywords provided by Sanofi ( Genzyme, a Sanofi Company ):


medullary thyroid cancer metastatic thyroid cancer carcinoma of the thyroid	receptor tyrosine kinase inhibitor VEGFR Unresectable locally advanced thyroid cancer

Additional relevant MeSH terms:


Thyroid Diseases Thyroid Neoplasms Endocrine System Diseases Endocrine Gland Neoplasms	Neoplasms by Site Neoplasms Head and Neck Neoplasms

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