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

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ClinicalTrials.gov Identifier: NCT03373903
Recruitment Status : Active, not recruiting
First Posted : December 14, 2017
Last Update Posted : May 16, 2018
Sponsor:
Information provided by (Responsible Party):
Restorbio Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Respiratory Tract Infections Other: Placebo Drug: BEZ235 Drug: BEZ235 plus everolimus (RAD001) Phase 2

Detailed Description:
This is a randomized, blinded, placebo-controlled, multicenter, parallel-group, dose finding 24-week study to assess the safety, tolerability and efficacy of up to 3 doses of BEZ235 alone and in combination with RAD001 as compared to placebo in elderly subjects who are at increased risk of respiratory tract infection related-morbidity and mortality. The study will be composed of up to a 6-week screening and run-in period, a 16-week treatment period and an 8-week follow-up period.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 652 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: A Multicenter, Dose-finding Study to Determine if Oral BEZ235 Alone or in Combination With RAD001 Decreases the Incidence of Respiratory Tract Infections in Elderly Subjects
Actual Study Start Date : November 15, 2017
Actual Primary Completion Date : May 3, 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo once daily for 16 weeks Other: Placebo
oral

Experimental: BEZ235 once daily for 16 weeks Drug: BEZ235
oral

Experimental: BEZ235 twice daily for 16 weeks Drug: BEZ235
oral

Experimental: BEZ235 plus RAD001 once daily for 16 weeks Drug: BEZ235 plus everolimus (RAD001)
Oral




Primary Outcome Measures :
  1. The percentage of subjects with 1 or more laboratory-confirmed RTIs through Week 16 [ Time Frame: 16 weeks ]

Secondary Outcome Measures :
  1. Percent of subjects who develop one or more RTIs through week 16 [ Time Frame: 16 weeks ]
  2. The rate of RTIs/person through week 16 [ Time Frame: 16 weeks ]
  3. The rate of RTIs per person through week 24 [ Time Frame: 24 weeks ]
  4. The percentage of subjects with 1 or more laboratory-confirmed RTIs through week 24 [ Time Frame: 24 weeks ]
  5. Peak Plasma Concentration (Cmax) [ Time Frame: 8 weeks ]
  6. Area under the plasma concentration versus time curve (AUC) [ Time Frame: 8 weeks ]


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male and female subjects
  • Age ≥ 85 years
  • Age ≥ 65 and < 85 years with one or more of the following conditions:

    • Asthma
    • Chronic Obstructive Pulmonary Disease (COPD)
    • Chronic bronchitis
    • Type 2 Diabetes Mellitus (T2DM)
    • Congestive Heart Failure (CHF) New York Heart Association (NYHA) functional classification I-II
    • Current smoker
    • One or more emergency room visits or hospitalizations for a RTI during the previous 12 months

Exclusion Criteria:

  • Subjects with medically significant cardiac conditions including NYHA functional classification III-IV
  • Subjects with Type I diabetes mellitus.
  • Subjects with clinically significant underlying pulmonary disease other than asthma, GOLD Class I and II COPD or chronic bronchitis
  • History of malignancy in any organ system within the past 5 years except for the following:

    • Localized basal cell or squamous cell carcinoma of the skin, prostate cancer confined to the gland, cervical carcinoma in situ, breast cancer localized to the breast.
  • Subjects with any one of the following:

    • hemoglobin < 10.0 g/dL for males and < 9.0 for females
    • white blood cell (WBC) count < 3,500/mm3,
    • neutrophil count < 2,000/mm3
    • platelet count < 125,000/mm3
  • Subjects with a history of a systemic autoimmune disease or receiving immunosuppressive therapy
  • Recent surgery other than minor skin surgery
  • Liver disease or liver injury
  • History or presence of impaired renal function
  • History of immunodeficiency diseases
  • Subjects with active infection
  • Subjects with a Mini Mental Status Examination (MMSE) score <24 at screening.
  • Significant illness (based on the subject's medical history and the clinical judgement of the investigator) which has not resolved within two (2) weeks prior to initial dosing.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03373903


Locations
United States, Kansas
Heartland Research Associates
Wichita, Kansas, United States, 67205
Sponsors and Collaborators
Restorbio Inc.
Investigators
Study Director: Sarb Shergill, PhD Restorbio Inc.

Responsible Party: Restorbio Inc.
ClinicalTrials.gov Identifier: NCT03373903     History of Changes
Other Study ID Numbers: RTB-BEZ235-202
First Posted: December 14, 2017    Key Record Dates
Last Update Posted: May 16, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Infection
Communicable Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Dactolisib
Everolimus
Sirolimus
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents