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Dual PI3K/mTOR Inhibitor
Dose Finding Study to Determine if BEZ235 Alone or in Combination With RAD001 Decreases the Incidence of Respiratory Tract Infections in the Elderly
Phase 2
Waitlist Available
Research Sponsored by Restorbio Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
Approved for 10 Other Conditions
Summary
The purpose of this study is to evaluate the efficacy, tolerability, and safety of BEZ235 alone and in combination with RAD001 to support further development to reduce the incidence of respiratory tract infections (RTIs) in elderly subjects.
Eligible Conditions
- Respiratory Infection
- Congenital Upper Airway Disorders
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
Trial Design
4Treatment groups
Experimental Treatment
Placebo Group
Group I: BEZ235 twice daily for 16 weeksExperimental Treatment1 Intervention
Group II: BEZ235 plus RAD001 once daily for 16 weeksExperimental Treatment1 Intervention
Group III: BEZ235 once daily for 16 weeksExperimental Treatment1 Intervention
Group IV: Placebo once daily for 16 weeksPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Dactolisib
Not yet FDA approved
Find a Location
Who is running the clinical trial?
Restorbio Inc.Lead Sponsor
4 Previous Clinical Trials
1,120 Total Patients Enrolled
Sarb Shergill, PhDStudy DirectorRestorbio Inc.
2 Previous Clinical Trials
53 Total Patients Enrolled