MedTrace Logo

Digoxin Induced Dissolution of CTC Clusters

NCT03928210 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2023-12-13

No results posted yet for this study

Summary

This single arm therapeutic exploratory study of digoxin in patients with advanced or metastatic breast cancer investigates whether cardiac glycosides are able to disrupt CTC clusters in breast cancer patients.

Conditions

Interventions

DRUG

Digoxin

Patients will receive a daily maintenance dose of digoxin. The daily dose of digoxin will be calculated according to the renal function and the target serum digoxin concentration and applied in an adjusted regimen based on the availability of 0.125 mg and 0.25 mg pills in the morning (before 10 am). Blood samples for analyses of mean CTC cluster size will be drawn at screening, on day 0 (2 hrs after first oral intake), on day 3 and on day 7. Depending on the digoxin serum level maintenance therapy with digoxin will be continued up to 3 weeks if the digoxin serum level on day 7 or day 14 is below 0.70 ng/ml. For the third week of maintenance therapy individual dose adjustments will be carried out as needed.

Sponsors & Collaborators

  • ETH Zurich - The Aceto Lab

    collaborator UNKNOWN

  • University Hospital, Basel, Switzerland

    lead OTHER

Principal Investigators

  • Christian Kurzeder, PD Dr. med · Breast Cancer Center, University Hospital Basel

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-08
Primary Completion
2023-12-01
Completion
2023-12-01

Countries

  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03928210 on ClinicalTrials.gov