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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)

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ClinicalTrials.gov Identifier: NCT01298323
Recruitment Status : Active, not recruiting
First Posted : February 17, 2011
Results First Posted : November 24, 2014
Last Update Posted : October 11, 2018
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )

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

Condition or disease Intervention/treatment Phase
Locally Advanced or Metastatic Medullary Thyroid Cancer Medullary Thyroid Cancer Behavioral: Patient outreach Drug: Vandetanib Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 205 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : February 25, 2011
Actual Primary Completion Date : April 2013
Estimated Study Completion Date : December 31, 2019


Arm Intervention/treatment
Active Comparator: Vandetanib Control
Control - treatment 300mg vandetanib opel label
Drug: Vandetanib
Treatment 300mg vandetanib opel label.
Other Name: SAR390530

Experimental: Experimental
Experimental - treatment 300mg vandetanib opel label
Behavioral: Patient outreach
Patients will be contacted at week 1 and then every 2 weeks until completion of 52 weeks to detect/treat AEs sooner

Drug: Vandetanib
Treatment 300mg vandetanib opel label.
Other Name: SAR390530




Primary Outcome Measures :
  1. 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. [ Time Frame: 12 months ]
    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.



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

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): NCT01298323


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Locations
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Australia
Investigational Site Number 301
St Leonards, Australia, 2065
Austria
Investigational Site Number 401
Wien, Austria, 1901
Belgium
Investigational Site Number 501
Bruxelles, Belgium, 1000
Brazil
Investigational Site Number 701
Porto Alegre, Brazil, 90035-003
Investigational Site Number 702
Ribeirão Preto, Brazil, 14048-900
Bulgaria
Investigational Site Number 901
Sofia, Bulgaria, 1527
Canada
Investigational Site Number 1001
London, Canada, N6A 4L6
Investigational Site Number 1002
Sherbrooke, Canada, J1H 5N4
Investigational Site Number 1003
Toronto, Canada, M5G2M9
China
Investigational Site Number 1301
Beijing, China, 100021
Investigational Site Number 1302
Shanghai, China
Czechia
Investigational Site Number 1901
Praha, Czechia, 15006
Denmark
Investigational Site Number 2001
Odense C, Denmark, 5000
Finland
Investigational Site Number 2201
Helsinki, Finland, FI-00029
Germany
Investigational Site Number 2602
Essen, Germany, 45122
Investigational Site Number 2603
Halle, Germany, 06120
Investigational Site Number 2601
Würzburg, Germany, 97080
Greece
Investigational Site Number 3001
Athens, Greece, 11528
India
Investigational Site Number 3501
Mumbai, India, 400012
Investigational Site Number 3502
Vellore, India, 632004
Israel
Investigational Site Number 4001
Jerusalem, Israel, 91120
Italy
Investigational Site Number 4104
Napoli, Italy
Investigational Site Number 4101
Pisa, Italy, 56124
Investigational Site Number 4102
Roma, Italy, 00161
Korea, Republic of
Investigational Site Number 6001
Seoul, Korea, Republic of
Poland
Investigational Site Number 5702
Poznan, Poland, 60-355
Investigational Site Number 5703
Warsaw, Poland, 02-781
Russian Federation
Investigational Site Number 6201
Moscow, Russian Federation, 115478
Investigational Site Number 6204
Moscow, Russian Federation, 125284
Investigational Site Number 6202
Obninsk, Russian Federation, 249036
Investigational Site Number 6203
St Petersburg, Russian Federation, 197022
Sweden
Investigational Site Number 7201
Uppsala, Sweden, 75185
United Kingdom
Investigational Site Number 2802
Glasgow, United Kingdom, G120YN
Investigational Site Number 2801
Sutton, United Kingdom, SM25PT
Sponsors and Collaborators
Genzyme, a Sanofi Company
Investigators
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Study Director: Clinical Sciences & Operations Sanofi

Additional Information:
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Responsible Party: Genzyme, a Sanofi Company
ClinicalTrials.gov Identifier: NCT01298323     History of Changes
Other Study ID Numbers: D4200C00088
2010-023428-26 ( EudraCT Number )
LPS14815 ( Other Identifier: Sanofi )
First Posted: February 17, 2011    Key Record Dates
Results First Posted: November 24, 2014
Last Update Posted: October 11, 2018
Last Verified: October 2018
Keywords provided by Sanofi ( Genzyme, a Sanofi Company ):
Medullary Thyroid Cancer
Locally advanced
Metastatic
Vandetanib
Patient Outreach
Additional relevant MeSH terms:
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Thyroid Neoplasms
Carcinoma, Neuroendocrine
Thyroid Diseases
Endocrine System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue