Patients with anaplastic thyroid cancer or with metastatic solid tumours MedDRA version: 9.1 Level: LLT Classification code 10002240 Term: Anaplastic thyroid cancer
Conditions
Interventions
Trade Name: PAXENE
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Paclitaxel
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 6-
Trad
Sponsors
AZIENDA SANITARIA OSPEDALIERA "S. GIOVANNI BATTISTA DI TORINO"
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patients with anaplastic thyroid cancer or with metaststic solid tumours, treated with paclitaxel 2.Age> 18 years 3.Performance status ≤ 2 (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 |
|---|---|
| Main Objective: Evaluation of the antitumour activity of valproic acid and paclitaxel in patients with anaplastic thyroid cancer;Secondary Objective: Determination of recommended dose of valproic acid in combined treatment with paclitaxel and evaluation of the effect of VPA on plasmatic levels and pharmacokinetic parameters of paclitaxel in patients with solid tumours;Primary end point(s): Evaluation of survival and response to treatment, following the WHO criteria | — |
Countries
Italy
Outcome results
None listed