Losartan and Sunitinib for Osteosarcoma
This study is testing a combination of two drugs, Losartan and Sunitinib, for treating osteosarcoma (a type of bone cancer). It's a Phase 1/1b trial, meaning the main goal is to find the safest and most effective dose of these drugs when given together. Researchers will start with lower doses and gradually increase them to find the highest dose that patients can tolerate. You may be able to join if you are 10 years or older and are willing to follow all study procedures. The study aims to determine the best dose for future research. The current status of this study is unclear.
- Study design
- This is a Phase 1/1b interventional study with a planned enrollment of 41 participants. It uses a 3+3 design to increase medication dosages until a maximally tolerated dose is found.
- What's involved
- You will take Losartan daily for 6 weeks and Sunitinib daily for 4 weeks, followed by a 2-week rest period. Dosing will be based on your weight or body surface area.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will assess dose-limiting toxicities, maximally tolerated dose, and recommended Phase 2 dose from the beginning of the study up to 4 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT03900793
Losartan + Sunitinib in Treatment of Osteosarcoma
Recruiting
PHASE1Ages 10+InterventionalTreatmentUniversity of Colorado, DenverInvestigator-initiated
~41 participants
Updated 2026-08-17 on ClinicalTrials.gov
What's tested:LosartanSunitinib
At a glance
Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Assessment of Dose-Limiting Toxicities of Losartan and Sunitinib Combination
Measured over Beginning of study to end of study, up to 4 years
+2 more outcomes measured
Conditions
Where it's being run
4 sites across 3 statesColorado2
California1
Georgia1
Study leadership
- Kelly Faulk, MD · PRINCIPAL_INVESTIGATOR · Children's Hospital Colorado
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
1\. Provision to sign and date the consent form (if individual is a minor, provision of a parent or legal guardian to sign and date the consent form and provision of individual to provide assent for study).
Patients with surface or periosteal osteosarcoma are not eligible.
Patients with active CNS metastasis are not eligible. Previously treated CNS metastases which occurred 3 months or more prior, without evidence of active recurrence, are acceptable.
Dose Escalation (Part A): Patients must have measurable or evaluable disease.
Cohort Expansion (Part B): Patients with measurable or evaluable disease and those with completely resected disease are eligible.
ECOG performance status (≥18 years old) ≤ 2 or Karnofsky performance score (\<18 years old)≥ 50.
Patients must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment. If after the required timeframe, the numerical eligibility criteria are met (e.g., blood count criteria) the patient is considered to have recovered adequately.
Exclusion
Peripheral absolute neutrophil count (ANC) ≥ 750/mm3
Platelet count ≥ 75,000/mm3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment).
Hemoglobin ≥ 8 g/dL (with or without transfusion) 9. Adequate renal function, defined as:
Creatinine clearance or radioisotope GFR \> 70 mL/min/1.73 m2 OR a serum creatinine based on age/gender.
Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age
SGPT (ALT) ≤ 135 U/L. For the purpose of this study, the ULN for SGPT is 45 U/L.
Serum albumin ≥ 2.8 g/dL 11. Patients with ≥ trace protein on urinalysis at screening will be allowed to enroll in the study at investigator discretion. A baseline urine protein creatinine ratio (UPC) should be obtained for patients with ≥ trace protein on urinalysis for consideration regarding Section 6.3.7 dose modification requirements.
Current cardiac ejection fraction \> 50% by biplane Simpson method on echocardiogram
QTc ≤ 480 ms 13. Patients with preexisting hyper- or hypothyroidism must be on a stable dose of medication.
Pregnant or breast-feeding women will not be entered on this study because there is not yet available information regarding human fetal or teratogenic toxicities. Pregnancy tests must be obtained in females who are post-menarchal.
Males or females of reproductive potential may not participate unless they have agreed to practice 1 highly effective and 1 additional effective (barrier) method of contraception at the same time during the entire study treatment period and through 3 months after the last dose of study drug, or agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the subject. Patients who themselves or their partners have undergone female or male sterilization do not require 2 methods of contraception. Highly effective methods are defined as those with \<1% failure rate with perfect use and include: oral contraceptive pills (combined or progesterone only), intrauterine devices (IUD), hormonal implant or injection, contraceptive patch, and vaginal ring. 8. Concomitant medications:
Anti-hypertensives: Patients who cannot be controlled to goal blood pressure for gender/age are not eligible.
Corticosteroids: Patients receiving systemic corticosteroids are not eligible. \> 14 days must have elapsed since last systemic corticosteroid. Note: patients using topical or inhaled corticosteroids are eligible.
Investigational Drugs: Patients currently receiving another investigational drug are not eligible.
Anti-cancer agents: Patients currently receiving other anti-cancer agents are not eligible.
Drug interactions: Patients who require treatment with medications that are strong inhibitors or inducers of CYP3A4 or inhibitors of CYP2A9 or have received these medications in the 7 days prior to enrollment, are not eligible. Patients who require treatment with enzyme inducing anticonvulsants are not eligible.
Medications that prolong QTc: Patients who require treatment with medications known to prolong QTc are not eligible
What this trial measures
- Assessment of Dose-Limiting Toxicities of Losartan and Sunitinib CombinationBeginning of study to end of study, up to 4 years
Assessment of Dose-Limiting Toxicities (DLTs) according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5 to assess the safety of the combination
- Maximally Tolerated Dose of Losartan and SunitinibBeginning of study to end of study, up to 4 years
The MTD will be defined as the dose level below that at which 1/3 or 2/6 patients experience DLTs.
- Recommended Phase 2 Dose of Losartan and SunitinibBeginning of study to end of study, up to 4 years
The dose than less that 33% of patients experience DLTs.