advanced (i.e. inoperable, recurrent or metastatic) gastric cancer or adenocarcinoma of the esophagogastric junction MedDRA version: 18.0 Level: PT Classification code 10001150 Term: Adenocarcinoma gastric System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 18.0 Level: LLT Classification code 10026104 Term: Malignant neoplasm of lower third of esophagus System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (inc
Conditions
Interventions
Trade Name: Afinitor
Product Name: Afinitor
Product Code: RAD001
Pharmaceutical Form: Tablet
INN or Proposed INN: Everolimus
CAS Number: 159351-69-6
Concentration unit: mg milligram(s)
Concentration
Sponsors
Krankenhaus Nordwest GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range 300
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Overall Survival;Secondary Objective: Treatment efficacy in terms of best overall response, disease control rate and progression free survival safety tolerability ;Primary end point(s): Overall survival in patients treated with Paclitaxel + RAD001 versus Paclitaxel + Placebo;Timepoint(s) of evaluation of this end point: every 2 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 ;Timepoint(s) of evaluation of this end point: efficacy: staging every 8 weeks toxicity: day 1, 8 and 15 of every cycle | — |
Countries
Germany
Outcome results
None listed