A study to learn how hereditary and sporadic thyroid cancer patients, treated with ZD6474 react to the drug, what happens to ZD6474 in the human body, about the side effects of ZD6474 and if ZD6474 can decrease or prevent tumour growth.
- Conditions
- Medullary thyroid cancerMedDRA version: 14.0Level: LLTClassification code 10027105Term: Medullary thyroid cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2005-005077-29-SE
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 331
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
;
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
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
;
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method