E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
advanced (i.e. inoperable, recurrent or metastatic) gastric cancer or adenocarcinoma of the esophagogastric junction |
|
E.1.1.1 | Medical condition in easily understood language |
advanced gastric cancer or cancer of the esophagogastric junction |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10001150 |
E.1.2 | Term | Adenocarcinoma gastric |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10026104 |
E.1.2 | Term | Malignant neoplasm of lower third of esophagus |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
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 |
|
E.2.2 | Secondary objectives of the trial |
Treatment efficacy in terms of best overall response, disease control rate and progression free survival safety tolerability
|
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Male or female patients ≥ 18 years old Histologically or cytologically confirmed and documented gastric adenocarcinoma or adenocarcinoma of the esophagogastric junction, if they have advanced disease (inoperable, recurrent or metastatic disease). Documented progressive disease during/after one or, two or three prior treatments containing 5FU/Platinum and/or its precursors or derivatives in the palliative setting. Neoadjuvant/adjuvant treatment is not counted, unless progression occurs < 6 months after completion of the treatment. In these cases, neoadjuvant/adjuvant treatment is counted as one line. At least one measurable or evaluable lesion by RECIST as determined by Computed Tomography (CT) Scan or Magnetic Resonance Imaging (MRI) ECOG performance status of 0, 1 or 2 adequate liver function adequate bone marrow function adequate renal function adequate contraception signed informed consent |
|
E.4 | Principal exclusion criteria |
Current treatment with any anti cancer therapy or treatment with anti cancer therapy ≤ 2 weeks prior to study treatment start unless rapidly progressing disease is measured Prior treatment with RAD001 Known hypersensitivity to RAD001 (everolimus) or to its excipients, or to other rapamycins (e.g. sirolimus, temsirolimus) Known prior history of hypersensitivity to paclitaxel Paclitaxel refractory disease, which is defined as a disease progression within 12 weeks or less of last administration of paclitaxel based treatment in any treatment line Chronic treatment with steroids (except for oral, topical or local injection) or another immunosuppressive agent Major surgery ≤ 2 weeks prior to starting study treatment or patients who have not recovered from such therapy Lack of resolution of all acute toxic effects (excluding alopecia) of prior chemotherapy, prior radiotherapy, or surgical procedure to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) grade ≤ 1. Note: Neuropathy due to prior chemotherapy is allowed. Unstable CNS disease Known history of HIV seropositivity (HIV testing is not mandatory) or Hepatitis B or C. Active, bleeding diathesis or on oral anti-vitamin K medication (except low dose warfarin, as long as the INR is <= 2.0) Any other severe and/or uncontrolled medical conditions Participation in other interventional clinical trial
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Overall survival in patients treated with Paclitaxel + RAD001 versus Paclitaxel + Placebo |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
Treatment efficacy in terms of best overall response, disease control rate and progression free survival AEs as determined by CTCAE version 4 and SAEs, discontinuation rate, dose adjustment rate and tolerability
|
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
efficacy: staging every 8 weeks toxicity: day 1, 8 and 15 of every cycle |
|
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
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 | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | 60 |
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 | Yes |
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
|
Last visit is the end of the study |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 4 |