Locally Advanced or Metastatic Medullary Thyroid Cancer, Medullary Thyroid Cancer
Conditions
Keywords
Medullary Thyroid Cancer, Locally advanced, Metastatic, Vandetanib, Patient Outreach
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
Interventions
BEHAVIORALPatient outreach
Patients will be contacted at week 1 and then every 2 weeks until completion of 52 weeks to detect/treat AEs sooner
DRUGVandetanib
Treatment 300mg vandetanib opel label.
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
Countries
Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Czechia, Denmark, Finland, Germany, Greece, India, Israel, Italy, Poland, Russia, South Korea, Sweden, United Kingdom
Contacts
STUDY_DIRECTORClinical Sciences & Operations
Sanofi
Participant flow
Recruitment details
From 25 February 2011 to 27 April 2012, 205 patients were randomized by 33 centers in global 20 countries.
Pre-assignment details
217 patients were screened; 205 patients were randomized in a 1:1 ratio to either Vandetanib 300 mg or Vandetanib 300 mg + Outreach Program arm in randomized treatment period for 12 months. Post completion of randomized treatment period, eligible patients entered continuing treatment period.
Participants by arm
| Arm | Count |
|---|---|
| Vandetanib 300mg Vandetanib (3 x 100 mg tablet form) was dosed orally, once daily | 102 |
| Vandetanib 300mg + Outreach Program Vandetanib (3 x 100 mg tablet form) was dosed orally, once daily | 103 |
| Total | 205 |
Baseline characteristics
| Characteristic | Vandetanib 300mg | Vandetanib 300mg + Outreach Program | Total |
|---|---|---|---|
| Age, Continuous | 50.8 Years STANDARD_DEVIATION 13.47 | 53.0 Years STANDARD_DEVIATION 14.34 | 51.9 Years STANDARD_DEVIATION 13.93 |
| Age, Customized >=18 - <40 Years | 21 Participants | 23 Participants | 44 Participants |
| Age, Customized >=40 - <65 Years | 65 Participants | 52 Participants | 117 Participants |
| Age, Customized >=65 - <75 Years | 15 Participants | 22 Participants | 37 Participants |
| Age, Customized >=75 Years | 1 Participants | 6 Participants | 7 Participants |
| Race/Ethnicity, Customized Asian | 15 Participants | 19 Participants | 34 Participants |
| Race/Ethnicity, Customized White | 87 Participants | 84 Participants | 171 Participants |
| Sex: Female, Male Female | 38 Participants | 37 Participants | 75 Participants |
| Sex: Female, Male Male | 64 Participants | 66 Participants | 130 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 16 / 102 | 11 / 103 | 7 / 55 | 7 / 55 |
| other Total, other adverse events | 96 / 102 | 89 / 103 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 27 / 102 | 31 / 103 | 18 / 55 | 21 / 55 |
Outcome results
Primary
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.
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.
Time frame: 12 months
Population: Number of Months Analyzed is the cumulative sum of number of months that all the participants were present in the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Vandetanib 300 mg+Outreach Program | 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. | 51.65 Percentage of days | Standard Deviation 35.548 |
| Vandetanib 300 mg | 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. | 45.19 Percentage of days | Standard Deviation 36.347 |
p-value: 0.19995% CI: [-3.44, 16.37]t-test, 2 sided