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Losartan + Sunitinib in Treatment of Osteosarcoma

NCT03900793 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2026-02-03

No results posted yet for this study

Summary

This study is a Phase 1/1b clinical trial that aims to determine the Maximally Tolerated Dose of Losartan and Sunitinib Combination Therapy. Patients will first be accrued to the Dose Escalation phase of the study, using a 3+3 design. Medication dosages will increase until a maximally tolerated dose is found. Patients will then be accrued to the Dose Expansion phase of the trial, where efficacy of pre-determined dose will be preliminarily assessed.

Conditions

Interventions

DRUG

Losartan

Losartan will be administered orally daily on days 1-42 (6 weeks) with dose level assignments. Dosing will be performed based on weight in kilograms and rounded to the nearest 12.5 mg (half of 25 mg tablet). Dose level 1 dosing will not exceed 50 mg daily, dose level 2 dosing will not exceed 100 mg daily, and dose level 3 dosing will not exceed 150 mg total daily (75 mg twice daily). Doses should be taken at approximately the same time daily and patients should fast for at least 4 hours prior to dosing

DRUG

Sunitinib

Sunitinib will be administered orally daily on days 1-28 (4 weeks), followed by 14-day rest period (2 weeks). Dosing will be performed based on body surface area (BSA) in mg/m2. Sunitinib is given as capsules or liquid formulation. Doses should be taken at approximately the same time daily.

Sponsors & Collaborators

  • Cancer League of Colorado

    collaborator OTHER

  • Colorado State University

    collaborator OTHER

  • Swim Across America

    collaborator OTHER

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Kelly Faulk, MD · Children's Hospital Colorado

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-26
Primary Completion
2026-08-31
Completion
2027-02-28
FDA Drug
Yes

Countries

  • United States

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 NCT03900793 on ClinicalTrials.gov