Safety and Efficacy of RAD001 (Everolimus) Monotherapy Plus Best Supportive Care in Patients With Advanced Gastric Cancer (AGC) GRANITE-1
- Conditions
- -C160 CardiaCardiaC160
- Registration Number
- PER-105-09
- Lead Sponsor
- OVARTIS BIOSCIENSES PERU S.A.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 11
• 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>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.<br><br>Measure:Overall Survival (OS)<br>Timepoints:2.5 years<br>
- Secondary Outcome Measures
Name Time Method