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 |
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Recruitment Status :
Active, not recruiting
First Posted : February 17, 2011
Results First Posted : November 24, 2014
Last Update Posted : January 14, 2021
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Sponsor:
Genzyme, a Sanofi Company
Information provided by (Responsible Party):
Sanofi ( Genzyme, a Sanofi Company )
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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 |
| 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, 2021 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Vandetanib
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Vandetanib Control
Control - treatment 300mg vandetanib opel label
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Drug: Vandetanib
Treatment 300mg vandetanib opel label.
Other Name: SAR390530 |
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Experimental: Experimental
Experimental - treatment 300mg vandetanib opel label
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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 :
- 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
Locations
Show 34 study locations
Sponsors and Collaborators
Genzyme, a Sanofi Company
Investigators
| Study Director: | Clinical Sciences & Operations | Sanofi |
Additional Information:
| Responsible Party: | Genzyme, a Sanofi Company |
| ClinicalTrials.gov Identifier: | NCT01298323 |
| 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: | January 14, 2021 |
| Last Verified: | December 2020 |
Keywords provided by Sanofi ( Genzyme, a Sanofi Company ):
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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 |