A Phase I/Ib Study of Losartan in Combination with Sunitinib in the Treatment of Pediatric and Adult Patients with Relapsed or Refractory Osteosarcoma
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.
Why this Research Matters
This study is designed to test the experimental combination of Losartan and Sunitinib in the hope of finding a drug combination that is safe and effective against osteosarcoma that has come back or not responded to standard therapy. There are two parts to this study. The first part is the dose-escalation phase. The main goal in this part of the study is to measure safety and side effects. Participants enrolled early will receive a lower dose of Losartan. Participants enrolled later will receive a higher dose of Losartan if lower doses appeared safe. The dose of Sunitinib may also be increased. The second part is called the dose-expansion phase. All participants will receive the same amount of Losartan and Sunitinib.
Who can Participate
Detailed eligibility criteria is available on clinicaltrials.gov. These requirements will be discussed with your doctor and/or study representative. Click the NCT number link below to learn more about this study on ClinicalTrials.gov
Study ID
Meet the Team
Principal Investigator
Categories
Locations
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Childrens Hospital Colorado
University of Colorado Hospital
- Childrens Healthcare of Atlanta
- Outpatient CTRC