Gastric Cancer HER2 negative MedDRA version: 14.1 Level: SOC Classification code 10029104 Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps) System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Pharmaceutical Form: Concentrate for solution for injection/infusion
INN or Proposed INN: DOCETAXEL
CAS Number: 114977-28-5
Concentration unit: mg/m2 milligram(s)/square meter
Concentration type: equa
Sponsors
GOIM GRUPPO ONCOLOGICO MERIDIONALE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Her 2 negative gastric cancer 2.No previous first line tratment 3.Performance Status ECOG = 2 4. Adeguate bone marrow, hepatic and renal function Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 21
Exclusion criteria
Exclusion criteria: 1.Histologically diagnosis of gastic cancer HER2 positive 2.More than one line of tretment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Objective Response Rate (%);Secondary Objective: Evaluate Toxicities, TTP, OS;Primary end point(s): Objective Response Rate (%);Timepoint(s) of evaluation of this end point: 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Evaluate Toxicities, TTP, OS;Timepoint(s) of evaluation of this end point: 24 months | — |
Countries
Italy
Contacts
Public ContactData Management GOIM
GOIM
Outcome results
None listed