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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 24 weeks
Awards & highlights

Study 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 ~24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The percentage of subjects with 1 or more laboratory-confirmed RTIs through Week 16
Secondary outcome measures
Area under the plasma concentration versus time curve (AUC)
Peak Plasma Concentration (Cmax)
Percent of subjects who develop one or more RTIs through week 16
+3 more

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Dose Finding Study to Determine if BEZ235 Alone or in Combination With RAD001 Decreases the Incidence of Respiratory Tract Infections in the Elderly
2017. "Dose Finding Study to Determine if BEZ235 Alone or in Combination With RAD001 Decreases the Incidence of Respiratory Tract Infections in the Elderly". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03373903.
All > Rsv > Afinitor
~88 spots leftby Apr 2025
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