RecruitingPhase 1NCT03900793

Losartan + Sunitinib in Treatment of Osteosarcoma

A Phase I/Ib Study of Losartan in Combination With Sunitinib in the Treatment of Pediatric and Adult Patients With Relapsed or Refractory Osteosarcoma

Sponsor

University of Colorado, Denver

Enrollment

41 participants

Start Date

Aug 26, 2019

Study Type

INTERVENTIONAL

Conditions

Osteosarcoma

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.

Eligibility

Min Age: 10 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a combination of losartan (a blood pressure medication) and sunitinib (a cancer-targeting drug) can help treat osteosarcoma — a type of bone cancer — that has come back or stopped responding to prior treatment. **You may be eligible if...** - You are 10 years of age or older - You have confirmed osteosarcoma that has relapsed or progressed after at least one prior treatment - No curative treatment is currently available for your cancer - You have adequate organ function and overall health **You may NOT be eligible if...** - You have surface or periosteal (outer bone surface) osteosarcoma - You have active spread of cancer to the brain or spinal cord - Your health or organ function does not meet requirements Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGLosartan

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

DRUGSunitinib

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.