Dose Finding Study to Determine if BEZ235 Alone or in Combination With RAD001 Decreases the Incidence of Respiratory Tract Infections in the Elderly

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.

Timeline

Start

2017-11-15

Primary completion

2018-05-03

Completion

2018-07

Outcome

Mixed primary results

paper efficacy of RTB101 10 mg in combination with everolimus 0·1 mg once daily compared with placebo did not meet statistical significance PMID 33977284 ↗

paper we found a statistically significant reduction in the proportion of patients who had one or more laboratory-confirmed RTIs in the RTB101 10 mg once daily treatment group PMID 33977284 ↗

Publications

• Mannick JB, Teo G, Bernardo P, Quinn D, Russell K, Klickstein L, Marshall W, Shergill S. Targeting the biology of ageing with mTOR inhibitors to improve immune function in older adults: phase 2b and phase 3 randomised trials. Lancet Healthy Longev. 2021 May;2(5):e250-e262. doi: 10.1016/S2666-7568(21)00062-3. Epub 2021 May 6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dactolisib	Small molecule	5 mg	Oral
Subject	Dactolisib	Small molecule	10 mg	Oral
Subject	Everolimus	Small molecule	0.1 mg	Oral

Indications