OVARIAN ADENOCARCINOMA MedDRA version: 6.1 Level: PT Classification code 10061328
Conditions
Interventions
Trade Name: CAELYX IV 1 FL 10 ML 2 MG/ML
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Doxorubicin
CAS Number: 25316-40-9
Concentration unit: mg milligram(s)
Concentration type: e
Sponsors
AZIENDA SANITARIA OSPEDALIERA S. GIOVANNI BATTISTA DI TORINO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. AGE MORE THAN 18 2. PATHOLOGICALLY CONFIRMED DIAGNOSIS OF RELAPSING OVARIUM ADENOCARCINOMA 3. AT LEAST ONE CHEMOTHERAPY REGIMEN 4. ECOG PS MINOR OR EQUAL THAN 2 5. LIFE EXPECTANCY MORE THAN 12 WEEKS 6. LVEF MORE THAN 50 7. NO OTHER MALIGNANCIES 8. NORMAL BLOOD, HEPATIC AND RENAL FUNCTIONS 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. PREGNANCY AND BREAST FEEDING; 2. ANY PREVIOUS TREATMENT WITH ANTHRACYCLINES AND GEMCITABINE; 3. HYPERSENSIBILITY TO CREMOPHOR EL-BASED PRODUCTS; 4. UNCONTROLLED INFECTIOUS DISEASES; 5. ANY RADIOTHERAPY REGIMEN DURING THE LAST 4 WEEKS; 6. CNS SYMPTOMATIC METASTASES
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - TIME TO PROGRESSION - TREATMENT RESPONSE RATE;Secondary Objective: - TOXICITY - OVERALL SURVIVAL;Primary end point(s): - TIME TO PROGRESSION - TREATMENT RESPONSE RATE | — |
Countries
Italy
Outcome results
None listed