PER-105-09Completed未知
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 sites11 target enrollmentStarted: November 18, 2009Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Enrollment
- 11
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 100 (—)
- Sex
- All
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
- •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
Investigators
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