Actively Recruiting

Phase 1
Age: 10Years +
All Genders
NCT03900793

Losartan + Sunitinib in Treatment of Osteosarcoma

Led by University of Colorado, Denver · Updated on 2026-02-03

41

Participants Needed

4

Research Sites

388 weeks

Total Duration

On this page

Sponsors

U

University of Colorado, Denver

Lead Sponsor

C

Cancer League of Colorado

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Losartan + Sunitinib in Treatment of Osteosarcoma

Who Can Participate

Age: 10Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent (or parent/guardian consent with minor assent)
  • Willingness to follow all study procedures and be available for full study duration
  • Male or female aged 10 years or older
  • Histologically confirmed osteosarcoma that recurred or progressed after at least one prior systemic therapy with no curative options
  • No surface or periosteal osteosarcoma
  • No active CNS metastases (treated CNS metastases over 3 months prior without recurrence allowed)
  • Measurable or evaluable disease for Dose Escalation phase; measurable, evaluable, or completely resected disease for Dose Expansion phase
  • ECOG performance status ≤ 2 for those 18 years or older; Karnofsky score ≥ 50 for those under 18
  • Fully recovered from acute toxic effects of prior anti-cancer therapies with specified minimum recovery times
  • Adequate bone marrow function: ANC ≥ 750/mm3, platelet count ≥ 75,000/mm3, hemoglobin ≥ 8 g/dL
  • Adequate renal function as defined by creatinine clearance or serum creatinine
  • Adequate liver function: total bilirubin ≤ 1.5 x ULN, ALT ≤ 135 U/L, serum albumin ≥ 2.8 g/dL
  • Patients with trace protein in urine may enroll with baseline urine protein creatinine ratio
  • Adequate cardiac function: ejection fraction > 50%, QTc ≤ 480 ms
  • Stable medication for any preexisting thyroid conditions
  • Ability to take and retain oral medications (including via nasogastric or gastrostomy tube)
Not Eligible

You will not qualify if you...

  • Major surgery within 14 days before treatment start (minor procedures like biopsy or central line placement allowed)
  • Uncontrolled bleeding disorders or clinically significant active bleeding
  • History of pulmonary embolism or serious thromboembolic event within 28 days
  • History of cardiac irradiation with mean dose > 15 Gy
  • Symptomatic cardiac disease above NYHA or Modified Ross class 2
  • History of cardiac dysfunction including low ejection fraction, severe angina, arrhythmias, stroke, or myocardial infarction
  • Pregnancy or breastfeeding; females post-menarchal must have pregnancy test; contraception required for reproductive potential
  • Uncontrolled blood pressure despite anti-hypertensive treatment
  • Recent systemic corticosteroids (less than 14 days ago); topical or inhaled corticosteroids allowed
  • Current use of other investigational drugs or anti-cancer agents
  • Use of medications that strongly affect CYP3A4 or CYP2A9 enzymes within 7 days prior to enrollment
  • Use of enzyme-inducing anticonvulsants
  • Use of medications known to prolong QTc interval

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

Children's Hospital Los Angeles

Los Angeles, California, United States, 90027

Actively Recruiting

2

Children's Hospital Colorado

Aurora, Colorado, United States, 80045

Actively Recruiting

3

University of Colorado Hospital

Aurora, Colorado, United States, 80045

Actively Recruiting

4

Children's Hospital of Atlanta

Atlanta, Georgia, United States, 30322

Actively Recruiting

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Research Team

K

Kelly Faulk, MD, MSCS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

1

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