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 1 or 2 Prior Systemic Chemotherapy

OVARTIS BIOSCIENSES PERU S.A.,0 个研究点目标入组 11 人开始时间: 2009年11月18日最近更新: 2023年9月4日

适应症

试验速览

暂无简介。

•Male or female patients> 18 years of age
•Gastric adenocarcinoma confirmed and documented histologically or cytologically. Patients with adenocarcinoma of the advanced gastroesophageal junction, of which at least 50% Involve the stomach, will be eligible for inclusion in the study.
•Documented progression after 1 or 2 previous systemic chemotherapy treatments for advanced disease
•EGOG functional status of <2
•Women with pregnancy potential should have a negative serum pregnancy test within 7 days of the first administration of the study treatments and must agree to use appropriate contraceptive methods during the study and for a period of time. 3 months after the last administration of the study drug
•Written informed consent

•Patients who have received> 2 previous systemic therapies for advanced disease
•Administration of antineoplastic therapy within 3 weeks before
•randomization, except for fluoropyrimidine alone, where randomization may occur 2 weeks after the last dose.
•Known hypersensitivity to RAD001 (everolimus) or its excipients or other rapamycins (eg, sirolimus, temsirolimus)
•Chronic steroid treatment (except oral, topical or local injection) or other immunosuppressive agent
•Major surgery <2 weeks before randomization
•Lack of resolution of all acute toxic effects (excluding alopecia) of previous chemotherapy, prior radiotherapy or surgical procedure according to the common terminology criteria for adverse effects (CTCAE) grade <1 of the National Cancer Institute (NCI)
•Patients with central nervous system metastases
•Known history of HIV seropositivity (HIV testing is not mandatory)
•Active hemorrhagic diathesis or with oral antivitamin K medication (except low doses of warfarin and acetylsalicylic acid, provided the INR is <2.0)
•Any serious or uncontrolled medical condition

发起方

OVARTIS BIOSCIENSES PERU S.A.,