Patients with undifferentiated thyroid cancer MedDRA version: 9.1 Level: LLT Classification code 10002240 Term: Anaplastic thyroid cancer
Conditions
Interventions
Trade Name: DEPAKIN*40CPR GASTROR 500MG
Pharmaceutical Form: Tablet
INN or Proposed INN: Valproic acid
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 500-
Trade N
Sponsors
AZIENDA SANITARIA OSPEDALIERA "S. GIOVANNI BATTISTA DI TORINO"
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Evaluation of survival and response to treatment, following the WHO criteria;Main Objective: Evaluation of the antitumour efficacy of valproic acid and paclitaxel in patients with undifferentiated thyroid cancer;Secondary Objective: Revaluation of the effect of VPA on plasmatic levels and pharmacokinetic parameters of paclitaxel to confirm that the treatment with VPA does not modify paclitaxel pharmacokinetic parameters. | — |
Countries
Italy
Outcome results
None listed