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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 : January 14, 2021
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )

Tracking Information
First Submitted Date  ICMJE February 16, 2011
First Posted Date  ICMJE February 17, 2011
Results First Submitted Date  ICMJE April 25, 2014
Results First Posted Date  ICMJE November 24, 2014
Last Update Posted Date January 14, 2021
Actual Study Start Date  ICMJE February 25, 2011
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 17, 2014)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 16, 2011)
  • Percentage of time a patient experienced at least one AE of CTCAE grade 2 or higher in the first 12 months of receiving vandetanib with the use of patient outreach program (week 0) [ Time Frame: AEs will be collected over 52 weeks on treatment (experimeantal group - week 1 and every 2 weeks thereafter; control - week 0 ]
    Percentage of time a patient experienced at least one AE of CTCAE grade 2 or higher in the first 12 months of receiving vandetanib with the use of patient outreach program
  • Percentage of time a patient experienced at least one AE of CTCAE grade 2 or higher in the first 12 months of receiving vandetanib with the use of patient outreach program - week 2 [ Time Frame: AEs will be collected over 52 weeks on treatment (experimeantal group - week 1 and every 2 weeks thereafter; control - week 2 ]
    Percentage of time a patient experienced at least one AE of CTCAE grade 2 or higher in the first 12 months of receiving vandetanib with the use of patient outreach program
  • Percentage of time a patient experienced at least one AE of CTCAE grade 2 or higher in the first 12 months of receiving vandetanib with the use of patient outreach program - week 4 [ Time Frame: AEs will be collected over 52 weeks on treatment (experimeantal group - week 1 and every 2 weeks thereafter; control - week 4 ]
    Percentage of time a patient experienced at least one AE of CTCAE grade 2 or higher in the first 12 months of receiving vandetanib with the use of patient outreach program
  • Percentage of time a patient experienced at least one AE of CTCAE grade 2 or higher in the first 12 months of receiving vandetanib with the use of patient outreach program - week 8 [ Time Frame: AEs will be collected over 52 weeks on treatment (experimeantal group - week 1 and every 2 weeks thereafter; control - week 8 ]
    Percentage of time a patient experienced at least one AE of CTCAE grade 2 or higher in the first 12 months of receiving vandetanib with the use of patient outreach program
  • Percentage of time a patient experienced at least one AE of CTCAE grade 2 or higher in the first 12 months of receiving vandetanib with the use of patient outreach program - week 13 [ Time Frame: AEs will be collected over 52 weeks on treatment (experimeantal group - week 1 and every 2 weeks thereafter; control - week 13 ]
    Percentage of time a patient experienced at least one AE of CTCAE grade 2 or higher in the first 12 months of receiving vandetanib with the use of patient outreach program
  • Percentage of time a patient experienced at least one AE of CTCAE grade 2 or higher in the first 12 months of receiving vandetanib with the use of patient outreach program - week 26 [ Time Frame: AEs will be collected over 52 weeks on treatment (experimeantal group - week 1 and every 2 weeks thereafter; control - week 26 ]
    Percentage of time a patient experienced at least one AE of CTCAE grade 2 or higher in the first 12 months of receiving vandetanib with the use of patient outreach program
  • Percentage of time a patient experienced at least one AE of CTCAE grade 2 or higher in the first 12 months of receiving vandetanib with the use of patient outreach program - week 39 [ Time Frame: AEs will be collected over 52 weeks on treatment (experimeantal group - week 1 and every 2 weeks thereafter; control - week 39 ]
    Percentage of time a patient experienced at least one AE of CTCAE grade 2 or higher in the first 12 months of receiving vandetanib with the use of patient outreach program
  • Percentage of time a patient experienced at least one AE of CTCAE grade 2 or higher in the first 12 months of receiving vandetanib with the use of patient outreach program - week 52 [ Time Frame: AEs will be collected over 52 weeks on treatment (experimeantal group - week 1 and every 2 weeks thereafter; control - week 52 ]
    Percentage of time a patient experienced at least one AE of CTCAE grade 2 or higher in the first 12 months of receiving vandetanib with the use of patient outreach program
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: February 16, 2011)
  • To collect additional information on the safety and tolerability (week 0) [ Time Frame: Over 52 weeks on treatment (week 0) ]
    To collect additional information on the safety and tolerability by assessment of Adverse Events (AEs), vital signs including blood pressure (BP), pulse,clinically significant laboratory abnormalities, ECG abnormalities
  • To collect additional information on the safety and tolerability (week 2) [ Time Frame: Over 52 weeks on treatment (week 2) ]
    To collect additional information on the safety and tolerability by assessment of Adverse Events (AEs), vital signs including blood pressure (BP), pulse,clinically significant laboratory abnormalities, ECG abnormalities
  • To collect additional information on the safety and tolerability (week 4) [ Time Frame: Over 52 weeks on treatment (week 4) ]
    To collect additional information on the safety and tolerability by assessment of Adverse Events (AEs), vital signs including blood pressure (BP), pulse,clinically significant laboratory abnormalities, ECG abnormalities
  • To collect additional information on the safety and tolerability (week 8) [ Time Frame: Over 52 weeks on treatment (week 8) ]
    To collect additional information on the safety and tolerability by assessment of Adverse Events (AEs), vital signs including blood pressure (BP), pulse,clinically significant laboratory abnormalities, ECG abnormalities
  • To collect additional information on the safety and tolerability (week 13) [ Time Frame: Over 52 weeks on treatment (week 13) ]
    To collect additional information on the safety and tolerability by assessment of Adverse Events (AEs), vital signs including blood pressure (BP), pulse,clinically significant laboratory abnormalities, ECG abnormalities
  • To collect additional information on the safety and tolerability (week 26) [ Time Frame: Over 52 weeks on treatment (week 26) ]
    To collect additional information on the safety and tolerability by assessment of Adverse Events (AEs), vital signs including blood pressure (BP), pulse,clinically significant laboratory abnormalities, ECG abnormalities
  • To collect additional information on the safety and tolerability (week 39) [ Time Frame: Over 52 weeks on treatment (week 39) ]
    To collect additional information on the safety and tolerability by assessment of Adverse Events (AEs), vital signs including blood pressure (BP), pulse,clinically significant laboratory abnormalities, ECG abnormalities
  • To collect additional information on the safety and tolerability (week 52) [ Time Frame: Over 52 weeks on treatment (week 52) ]
    To collect additional information on the safety and tolerability by assessment of Adverse Events (AEs), vital signs including blood pressure (BP), pulse,clinically significant laboratory abnormalities, ECG abnormalities
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Locally Advanced or Metastatic Medullary Thyroid Cancer
  • Medullary Thyroid Cancer
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: Vandetanib Control
    Control - treatment 300mg vandetanib opel label
    Intervention: Drug: Vandetanib
  • Experimental: Experimental
    Experimental - treatment 300mg vandetanib opel label
    Interventions:
    • Behavioral: Patient outreach
    • Drug: Vandetanib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: October 11, 2016)
205
Original Estimated Enrollment  ICMJE
 (submitted: February 16, 2011)
154
Estimated Study Completion Date  ICMJE December 31, 2021
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Austria,   Belgium,   Brazil,   Bulgaria,   Canada,   China,   Czechia,   Denmark,   Finland,   Germany,   Greece,   India,   Israel,   Italy,   Korea, Republic of,   Poland,   Russian Federation,   Sweden,   United Kingdom
Removed Location Countries Czech Republic,   Netherlands,   Norway,   Romania,   Switzerland
 
Administrative Information
NCT Number  ICMJE NCT01298323
Other Study ID Numbers  ICMJE D4200C00088
2010-023428-26 ( EudraCT Number )
LPS14815 ( Other Identifier: Sanofi )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanofi ( Genzyme, a Sanofi Company )
Study Sponsor  ICMJE Genzyme, a Sanofi Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Sciences & Operations Sanofi
PRS Account Sanofi
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP