A randomized, double-blind, multi-center phase III study evaluating paclitaxel with and without RAD001 in patients with gastric carcinoma who have progressed after therapy with a fluoropyrimidine/platinum-containing regimen

Krankenhaus Nordwest GmbH0 个研究点目标入组 300 人开始时间: 2011年4月27日最近更新: 2020年6月22日

试验速览

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•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
•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 300
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 300

•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

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