E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with Locally Advanced or Metastatic Adenocarcinomas of the Stomach and Gastro-esophageal junction |
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E.1.1.1 | Medical condition in easily understood language |
Adenocarcinomas of the Stomach and Gastro-esophageal junction |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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 |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | 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) . |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Progression Free Survival (PFS) is defined as the median time interval from the time of enrolment to the date of first documented of disease progression, or patient’ death of any cause. Median Overall Survival (mOS) is considered as the interval from the time of enrolment to the date of patient’ death of any cause. Safety assessment will be based on the incidence of adverse events, SAEs, modifications in laboratory parameters, dose reductions or treatment delays and treatment discontinuations due to toxicity or deterioration of performance status. Adverse events (AEs) will be evaluated according to NCI-Common Toxicity Criteria version 4.0 (National Cancer Institute Common Toxicity Criteria v4.0; Siegel R). AEs will be evaluated every 2 weeks, before the administration of the next treatment cycle. Haematology test with differential neutropheels count will be performed every week during the treatment and every 2 months during the follow-up period. Biochemistry test will be performed every 2 weeks during the treatment and every 2 months during the follow-up period. Vital sign and ECG will be assessed every 2 weeks, before the administration of the next treatment cycle. Exploratory analysis of predictive biomarkers will be performed in the primary tumors of the enrolled patients. Analysis of gene correlated with resistance (TXR1, TSP1) or sensitivity (BRCA1) will be carried with the use of RT-qPCR. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 10 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 24 |
E.8.9.1 | In the Member State concerned days | |