None listed
Conditions
Interventions
Group 1 Type of group
All patients were randomized to receive everolimus + BSC. All patients orally took two 5 mg tablets of everolimus once daily. Therefore, all patients in the everolimus arm took a total daily dose of 10 mg. Best supportive care was in accordance with the local practice of an individual institution or center, and specifically excluded anti-cancer treatments.
Group name:Group 2 Type of group
All patients were randomized to receive placebo + BSC. All patients orally took two 5 mg tablets of matching placebo once daily. Therefore, all patients in the placebo receive matching tablets of total daily dose of 10 mg. Best supportive care was in accordance with the local practice of an individual institution or center, and specifically excluded anti-cancer treatments.
Sponsors
NOVARTIS BIOSCIENSES PERU S.A.,
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: • 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
Exclusion criteria
Exclusion criteria: • 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:The primary objective of this study was to compare OS between everolimus + best supportive care (BSC) and placebo + BSC. OS, was defined as the time from date of randomization to the date of death due to any cause. If at the analysis cut-off date a patient was not known to have died, survival was censored at the date of the last contact. OS was analyzed using the Kaplan Meier estimates method. Measure:Overall Survival (OS) Timepoints:2.5 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Progression free survival was defined as the time from the date of randomization to the date of the first documented disease progression or death due to any cause, where progression was based on Investigator assessment of baseline and post-baseline scans according to RECIST. Progression free survival was censored if no PFS event was observed before the first to occur out of (i) the cut-off date, or (ii) the date when a further anticancer therapy was started. The censoring date was the date of the last adequate tumor assessment before either of these two events occurred. If a PFS event was observed after two or more missing or non-evaluable tumor assessments, then the date of progression was censored at the date of the last adequate tumor assessment; for a PFS event observed after a single missing or non-evaluable tumor assessment, the actual date of disease progression was used. Anslsis was done using Kaplan-Meier estimates method. Measure:Progression Free Survival (PFS) Timepoints:2.5 years ; Outcome name:The EORTC QLQ-C30 global health status/quality of life sub-scale (QL) was pre-specified as the primary domain of interest, followed by physical functioning (PF), social functioning (SF) and emotional functioning (EF).The EORTC QLQ-C30 questionnaire, along with a module specific for gastric cancer patients (EORTC QLQ-STO22), was used to evaluate PRO. The QLQ-C30 has five function scales (physical, role, cognitive, emotional and social), three symptom scales (fatigue, pain and nausea/vomiting) and a global health status/quality of life scale. In addition, there are questions that assess specific symptoms. The QLQ-STO22 consists of 22 questions that make up five multi-item scales (dysphagia, pain, reflux, eating and anxiety) and four single-item scales (dry mouth, tasting, body image and hair loss). Measure:Patient Reported Outcome (PRO): Time to Definitive Deterioration of European Organisation for Research and Treatment of Cancer Q | — |
Countries
Argentina, Australia, Belgium, Brazil, Canada, China, Colombia, France, Germany, Hong Kong, Israel, Italy, Japan, Korea South, Mexico, Netherlands, New Zealand, Russian Federation, Spain, Taiwan, Thailand, United Kindgdom, United States, Venezuela
Contacts
Public ContactJuan Reyes
NOVARTIS BIOSCIENCES PERU S.A.
Outcome results
None listed