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Phase IB Metformin, Digoxin, Simvastatin in Solid Tumors

NCT03889795 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2025-10-20

No results posted yet for this study

Summary

This is a single-center trial in subjects with pancreatic cancer and other advanced solid tumors. It is an open-label, single arm dose escalation Phase IB trial with subjects accrued in a 3 subject dose escalation cohort. Subjects with treated advanced solid tumors, and showing disease progression on established standard therapy, will be enrolled in this trial.

Conditions

  • Advanced Pancreatic Cancer
  • Advanced Solid Tumor

Interventions

DRUG

Metformin

Metformin oral pill will be taken daily at breakfast (cohort 1) and breakfast and dinner (cohort 2 and 3).

DRUG

Simvastatin

Simvastatin oral pill will be taken daily in the evening.

DRUG

Digoxin

Digoxin oral pill will be taken once daily.

Sponsors & Collaborators

  • Danae Hamouda, MD

    lead OTHER

Principal Investigators

  • Danae Hamouda, MD · University of Toledo

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-05
Primary Completion
2026-12-30
Completion
2027-12-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT03889795 on ClinicalTrials.gov