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Dual PI3K/mTOR Inhibitor

BEZ235 once daily for 16 weeks for Respiratory Infection

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

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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
42 Total Patients Enrolled
~83 spots leftby Sep 2025
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