ew therapeutic approaches for anaplastic thyroid cancer: assessment of the benefit-risk profile of the combination valproic acid-paclitaxel. - ND
- Conditions
- Patients with undifferentiated thyroid cancerMedDRA version: 9.1Level: LLTClassification code 10002240Term: Anaplastic thyroid cancer
- Registration Number
- EUCTR2008-005221-11-IT
- Lead Sponsor
- AZIENDA SANITARIA OSPEDALIERA S. GIOVANNI BATTISTA DI TORINO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
1.Patients with undifferentaited thyroid cancer treated with paclitaxel
2.Age> 18 years
3.Performance status ≤ 3 (ECOG).
4.Availability to give a written informed consent
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1.Hepatic (bilirubin > 2mg/dl; ALT > 3 times the upper limit of normality) and/or renal (creatinine > 2mg/dl) failure
2.Thrombocytopenia and/or thrombocytopathy
3.Treatment with aspirin or antiplatelet agents
4.Treatment with antipsychotic drugs
5.Impossibility to get an informed consent due to impaired consciousness
6.Pregnant or breastfeeding women
7.Fertile women not taking contraceptive pills
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