Medullary thyroid cancer MedDRA version: 15.0 Level: LLT Classification code 10027105 Term: Medullary thyroid cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: ZICTIFA 300mg
Product Code: ZD6474
Pharmaceutical Form: Tablet
INN or Proposed INN: vandetanib
Current Sponsor code: ZD6474
Concentration unit: mg milligram(s)
Concentration type: equal
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Confirmed diagnosis of unresectable, locally advanced or metastatic hereditary or sporadic MTC. Presence of a measurable tumour Able to swallow medication Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 262 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 69 ;Inclusion criteria: Confirmed diagnosis of unresectable, locally advanced or metastatic hereditary or sporadic MTC. Presence of a measurable tumour Able to swallow medication Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 262 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 69
Exclusion criteria
Exclusion criteria: Major surgery within 4 weeks before randomisation The last dose of prior chemotherapy received less than 4 weeks prior to randomization Radiation therapy within the last 4 weeks prior to randomization (with the exception of palliative radiotherapy) Brain metastases or spinal cord compression, unless treated at least 4 weeks before first dose and stable without steroid treatment for 10 days Significant cardiac event Previous ZD6474 treatment ;Exclusion criteria: Major surgery within 4 weeks before randomisation The last dose of prior chemotherapy received less than 4 weeks prior to randomization Radiation therapy within the last 4 weeks prior to randomization (with the exception of palliative radiotherapy) Brain metastases or spinal cord compression, unless treated at least 4 weeks before first dose and stable without steroid treatment for 10 days Significant cardiac event Previous ZD6474 treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate an improvement in progression-free survival (PFS) with ZD6474 as compared to placebo in subjects with unresectable locally advanced or metastatic MTC;Secondary Objective: 1. To demonstrate an improvement in the overall objective response rate (ORR), disease control rate (DCR), and duration of response (DOR) with ZD6474 as compared to placebo 2. To demonstrate an improvement in the overall survival (OS) in subjects with MTC who have been treated with ZD6474 as compared to placebo 3. To demonstrate an improvement in biochemical response with ZD6474 as compared to placebo as measured by calcitonin (CTN) and carcinoembryonic antigen (CEA) 4. To demonstrate a delay in time to worsening of pain (TWP) among subjects with MTC after treatment with ZD6474 as compared to placebo 5. To determine the pharmacokinetics (PK) of ZD6474 in this subject population and investigate any influence of subject demography and pathophysiology on the PK PLUS other secondary and exploratory objectives as detailed in the protocol;Primary end point(s): Progression free survival;Timepoint(s) of evaluation of this end point: Time to progression or death;Main Objective: To demonstrate an improvement in progression-free survival (PFS) with ZD6474 as compared to placebo in subjects with unresectable locally advanced or metastatic MTC;Secondary Objective: 1. To demonstrate an improvement in the overall objective response rate (ORR), disease control rate (DCR), and duration of response (DOR) with ZD6474 as compared to placebo 2. To demonstrate an improvement in the overall survival (OS) in subjects with MTC who have been treated with ZD6474 as compared to placebo 3. To demonstrate an improvement in biochemical response with ZD6474 as compared to placebo as measured by calcitonin (CTN) and carcinoembryonic antigen (CEA) 4. To demonstrate a delay in time to worsening of pain (TWP) among subjects with MTC after treatment with ZD6474 as compared to placebo 5. To deter | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Objective Response Rate by RECIST, Disease Control Rate and Duration of Response 2. Overall Survival 3. CTN and CEA 4. Time to Worsening of Pain 5. Incidence and type of AEs, clinically significant laboratory abnormalities, ECG changes and vital signs 6. Other PK variables ;Timepoint(s) of evaluation of this end point: See protocol study plan for detailed information regarding the timing of these evaluations;Secondary end point(s): 1. Objective Response Rate by RECIST, Disease Control Rate and Duration of Response 2. Overall Survival 3. CTN and CEA 4. Time to Worsening of Pain 5. Incidence and type of AEs, clinically significant laboratory abnormalities, ECG changes and vital signs 6. Other PK variables ;Timepoint(s) of evaluation of this end point: See protocol study plan for detailed information regarding the timing of these evaluations | — |
Countries
Austria, Belgium, Brazil, Canada, Denmark, France, Germany, Hungary, India, Italy, Korea, Republic of, Mexico, Netherlands, Portugal, Russian Federation, Serbia, Spain, Sweden, United Kingdom
Contacts
Public ContactInformation Centre;Information Centre ;
AstraZeneca;AstraZeneca
Outcome results
None listed