EUCTR2008-006544-20-DE进行中（未招募）不适用
A randomized, double-blind, multi-center phase III study comparing everolimus (RAD001) plus best supportive care versus placebo plus best supportive care in patients with advanced gastric cancer after progression on prior systemic chemotherapy
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 633
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Male or female patients = 18 years old
- •Histologically or cytologically confirmed and documented gastric adenocarcinoma. Patients with advanced gastro-esophageal junction adenocarcinoma, of which the majority, as assessed by the investigator, involves the stomach, will be eligible for inclusion in the study.
- •Documented progression after 1 or 2 prior systemic chemotherapy lines for advanced disease
- •Note: One line of therapy in the advanced disease setting consists of one or more drugs which are given for 21 days or longer.
- •Note: Prior adjuvant/neoadjuvant therapy is allowed. If recurrence occurred during adjuvant/neoadjuvant therapy or = 24 weeks after adjuvant/neoadjuvant therapy completion, the adjuvant/neoadjuvant therapy will be considered as one prior line of systemic chemotherapy for advanced disease
- •Note: Prior treatment with chemotherapy combined with targeted agents is permitted.
- •ECOG performance status of = 2
- •Patients with the following laboratory parameters can be included:
- •o Absolute neutrophil count = 1.5 x 109/L (= 1500/mm3)
- •o Platelets = 100 x 109/L (= 100,000/mm3)
- •o Hemoglobin (Hgb) = 8 g/dL (= 4.9 mmol/L)
- •o INR = 2.0
- •o Serum creatinine = 2 x Upper Limit of Normal (ULN)
- •o Adequate liver function as defined as:
- •If there is no evidence of liver metastasis: ALT and AST = 2.5 x ULN
- •If liver metastases are documented: ALT and AST = 5.0 x ULN
- •o Serum bilirubin = 1.5 x ULN
- •o Total serum calcium (corrected for serum albumin) or ionized calcium = LLN
- •o Serum potassium = Lower Limit of Normal
- •Note: Calcium, potassium, magnesium, and phosphate supplements may be given to correct values that are below the LLN, but must be documented as corrected prior to
- •patients enrolling on the study
- •Women of childbearing potential must have a negative serum pregnancy test within 7 days of the first administration of study treatments and must be willing to use adequate methods of contraception during the study and for 8 weeks after last study drug administration
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients who have received > 2 prior lines of systemic therapy for advanced disease
- •See notes under inclusion criterion 3.
- •Administration of anti-cancer therapy within 3 weeks prior to randomization, except for fluoropyrimidine monotherapy, where randomization may occur 2 weeks after last dose.
- •Known hypersensitivity to RAD001 (everolimus) or to its excipients, or to other rapamycins (e.g., sirolimus, temsirolimus)
- •Chronic treatment with steroids (except for oral, topical or local injection) or another immunosuppressive agent
- •Major surgery = 2 weeks prior to randomization
- •Note: Patients must have recovered from the acute effects of surgery prior to randomization.
- •Malignant ascites requiring invasive treatment (such as ascites drainage)
- •Lack of resolution of all acute toxic effects of prior chemotherapy, prior radiotherapy, or surgical procedure according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade = 1 with the
- •exception of neuropathy (inclusion of patients with neuropathy of Grade 2 or less is
- •permitted) and alopecia.
- •Patients with central nervous system metastases
- •Known history of HIV seropositivity (HIV testing is not mandatory)
- •Active, bleeding diathesis, or on oral anti-vitamin K medication (except low dose warfarin and acetylsalicylic acid, as long as the INR is = 2.0)
- •Any primary malignancy within 3 years prior to randomization, with the exception of
- •adequately treated in-situ carcinoma of the cervix uteri, basal or squamous cell carcinoma
- •Any severe and/or uncontrolled medical conditions which could cause unacceptable safety risks or compromise compliance with the protocol, such as:
- •o Unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction = 24 weeks prior to enrollment, serious uncontrolled cardiac arrhythmia
- •o Uncontrolled diabetes as defined by fasting serum glucose > 1.5 X ULN
- •o = Grade 3 hypercholesterolemia/hypertriglyceridemia or = Grade 2 hypercholesterolemia/hypertriglyceridemia with history of coronary artery disease (despite lipid-lowering treatment if given)
- •o Acute and chronic, active infectious disorders and nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the complications of this study therapy
- •o Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of study drugs, with the exception of prior gastrectomy (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome).
- •Note: Data from the phase II Japanese study of RAD001 in AGC does not suggest that gastrectomy impairs the absorption of RAD001.
- •o Active skin, mucosa, ocular or GI disorders of Grade > 1
- •o Chronic obstructive or chronic restrictive pulmonary disease including dyspnea at rest from any cause
- •Patients who are enterally fed (e.g. via a nasogastric or nasojejunal tube, or via a
- •gastrostomy or jejunostomy)
研究者
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A randomized, double-blind, multi-center phase III study comparing everolimus (RAD001) plus best supportive care versus placebo plus best supportive care in patients with advanced gastric cancer after progression on prior systemic chemotherapyadvanced gastric cancerMedDRA version: 9.1Level: PTClassification code 10017758Term: Gastric cancerEUCTR2008-006544-20-FRovartis Pharma Services AG633