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• Conditions: Patients with Locally Advanced or Metastatic Adenocarcinomas of the Stomach and Gastro-esophageal junction; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-002179-32-GR
• Lead Sponsor: Hellenic Oncology Research Group (H.O.R.G.)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08-08
• Last Update Posted: 2 May 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Histologically proven inoperable locally advanced or metastatic adenocarcinoma of the stomach (including adenocarcinoma of the gastrooesophageal junction)
Age > 18 years old
Assessable target lesion(s) as defined by RECIST criteria v1.1
Disease progression after treatment with the DCF regimen
ECOG performance status = 1
Hgb = 8g/dL, WBC = 3 x 109/L , neutrophils count = 1.5 x 109/L , platelets =100 x 109/L
Creatinine clearance =50 mL/min
Total bilirubin = 1.5 X UNL
AST, ALT and ALP = 2.5 x UNL
Estimated life expectancy more than 3 months
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 59
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 59

Exclusion Criteria

Gastrointestinal bleeding
Clinically relevant, symptomatic excessive amounts of ascites resulting in patient’s discomfort
CNS metastases
Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment.
Subject (male or female) is not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment.
Known hypersensitivity reaction to the component of the treatment.
Active infection or malnutrition or bowel obstruction.
Legal incapacity or limited legal capacity
Definite contraindications for the use of corticosteroids
History of interstitial lung disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung disease on baseline chest CT scan.
Chronic inflammation of the bowel.
Clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) = 1 year before enrollment
Medical or psychological condition which in the opinion of the investigator would not permit the subject to complete the study or sign meaningful informed consent.
Second primary tumor other than non-melanoma skin cancer or in situ cervical cancer.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the objective response (CR and PR) rates of nab-Paclitaxel as salvage treatment in patients with metastatic/locally advanced gastric or GEJ cancer previously treated with DCF.;Secondary Objective: To estimate Progression Free Survival (PFS), median Overall Survival (mOS), and evaluate the safety profile of nab-Paclitaxel in pretreated patients with metastatic/locally advanced gastric or GEJ cancer. To determine predictive biomarkers of response or resistance in the primary tumor of enrolled patients.her language that is applicable;Primary end point(s): Documented Objective Response Rate (ORR) will be assessed every two months (3 treatment cycles) according to RECIST vs.1.1 criteria for tumor response (RECIST criteria version 1.1) .;Timepoint(s) of evaluation of this end point: Every 2 months