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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03532035
Other study ID # CMX001-211
Secondary ID
Status Withdrawn
Phase Phase 2
First received
Last updated
Start date December 15, 2018
Est. completion date May 10, 2019

Study information

Verified date July 2021
Source Chimerix
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a randomized, controlled, open-label, multicenter study to evaluate the safety, tolerability, pharmacokinetic (PK), and adenovirus (AdV) antiviral activity of multiple ascending doses of IV brincidofovir (BCV). Approximately 30 eligible subjects will be sequentially enrolled into 1 of 3 planned cohorts. Within each cohort, subjects will be randomized in a 4:1 ratio to receive IV BCV dosed twice weekly (BIW) (on Days 1, 4, 8, and 11) or to receive investigator-assigned standard of care (SoC).


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date May 10, 2019
Est. primary completion date May 10, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 99 Years
Eligibility Inclusion Criteria: - Be = 18-years-old (or per local law or regulations on legal age of consent). - Have received an allogeneic hematopoietic cell transplant (HCT) within the previous 100 days. - Have plasma AdV DNA viremia = 1,000 copies/mL (via quantitative polymerase chain reaction assay; local results must be confirmed by the designated central virology laboratory). Exclusion Criteria: - Diarrhea meeting the US National Institutes of Health (NIH)/National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade 2 or greater - Acute graft versus host disease (GVHD) 1. NIH Stage 2 or higher acute GVHD of the gut (i.e., diarrhea > 1,000 mL/day, or severe abdominal pain with or without ileus) or liver (i.e., bilirubin > 3 mg/dL : > 51 µmol/L) within 7 days prior to Day 1 2. Any NIH Stage 3 or Stage 4 acute GVHD within 7 days prior to Day 1 - Concurrent human immunodeficiency virus or active hepatitis B or C infection - An estimated creatinine clearance of < 30 mL/min, and/or use of renal replacement therapy within 7 days prior to Day 1. - Poor clinical prognosis, including active malignancy, irreversible organ failure, use of vasopressors, requirement for mechanical ventilation, resting oxygen saturation < 88%, or Pulmonary Arterial oxygen (PaO2) = 55 mm Hg without supplemental oxygen at any time within 7 days prior to Day 1. - Receiving or anticipated to start systemic cyclosporine immunosuppressant treatment during study participation. - Received treatment with CDV within 14 days prior to Day 1. - Previous receipt of cell-based anti-AdV therapy within 6 weeks prior to Day 1 or prior receipt of an anti-AdV vaccine at any time. - Consumed food products containing sesame seeds, sesame oil, or dietary supplements containing sesamin within 3 days prior to Day 1. - Received any investigational drug within 28 days prior to Day 1 or currently participating in another interventional study. - Pregnant or breastfeeding.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Brincidofovir
Subjects will receive BCV administered as a continuous IV infusion over 2 hours twice weekly (on Days 1, 4, 8, and 11) for a period of 2 weeks (total of 4 doses).
Standard of Care
Subjects randomized to the SoC in each cohort will be managed per local institutional guidelines and investigator judgement. SoC treatment options may include, but are not limited to, taking a "watch and-wait" approach, with or without decreased immunosuppression (i.e., no active treatment), or treatment with IV CDV, ganciclovir, or ribavirin.

Locations

Country Name City State
Italy University Vita-Salute San Raffaele. San Faffaele Scientific Institute Milan
Spain Hospital Universitari Vall d'Hebron Barcelona
Spain Hospital Clinico Universitario de Salamanca Salamanca
Spain Hospital Universitari I Politecnic la Fe Valencia
United States Brigham and Womens Hospital Boston Massachusetts
United States University of Chigago Chicago Illinois
United States MD Anderson Cancer Center Houston Texas
United States UCLA Medical Center Los Angeles California

Sponsors (1)

Lead Sponsor Collaborator
Chimerix

Countries where clinical trial is conducted

United States,  Italy,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Plasma area under the curve (AUC) of BCV BCV AUC will be determined by analysis of BCV plasma concentrations at the following time points after the start of Dose 1 and Dose 4: 30 minutes, and 2.5, 3, 4, 8, 10, 12, 36, and 72 hours 15 days
Primary Plasma Cmax of BCV BCV Cmax will be determined by analysis of BCV plasma concentrations at the following time points after the start of Dose 1 and Dose 4: 30 minutes, and 2.5, 3, 4, 8, 10, 12, 36, and 72 hours 15 days
Primary Incidence (number and percentage of subjects) of treatment-emergent adverse events 22 days
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