← Back to Search

Angiotensin II Receptor Blocker

Losartan + Sunitinib for Osteosarcoma

Phase 1
Recruiting
Led By Kelly Faulk, MD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Platelet count ≥ 75,000/mm3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment).
Prior Therapy:
Timeline
Screening 3 weeks
Treatment Varies
Follow Up beginning of study to end of study, up to 4 years
Awards & highlights

Study Summary

This trial is testing a combination of two drugs to see what the highest dose is that people can tolerate without serious side effects. Once they find that, they'll test that dose to see if it's effective.

Who is the study for?
This trial is for individuals over 10 years old with osteosarcoma that has recurred or progressed after prior therapy. They must be able to take oral medication, have stable thyroid function on current meds, and not be pregnant or breastfeeding. Participants need normal organ function and can't have had major surgery within the last two weeks or a history of significant heart disease.Check my eligibility
What is being tested?
The study tests the combination of Losartan and Sunitinib to find the highest dose patients can tolerate without severe side effects (Phase 1). After determining this dose, more patients will receive it to see how effective it is against osteosarcoma (Phase 1b), using a step-by-step approach where doses increase gradually.See study design
What are the potential side effects?
Possible side effects include high blood pressure from Losartan and fatigue, diarrhea, skin problems, mouth sores, nausea, vomiting, high blood sugar levels from Sunitinib. There may also be risks due to lowered immune system function leading to increased infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My platelet count is above 75,000 and I haven't had a transfusion in the last week.
Select...
I have received previous treatments for my condition.
Select...
It's been over 14 days since my last long-acting growth factor dose or 7 days for a short-acting one.
Select...
My osteosarcoma is not just on the surface or outer layer of the bone.
Select...
It's been over 3 weeks since my last chemotherapy that affects my bone marrow.
Select...
My condition is currently active.
Select...
My blood tests show my bone marrow is working well.
Select...
I do not have active brain metastases but had treated ones over 3 months ago with no recurrence.
Select...
I have not received heart radiation exceeding 15 Gy.
Select...
I am older than 10 years.
Select...
My thyroid condition is stable on my current medication.
Select...
I can take pills by mouth or through a feeding tube.
Select...
It's been over 21 days since my last antibody treatment and any side effects are mild.
Select...
It has been more than 14 days since my last corticosteroid dose.
Select...
My liver is working well.
Select...
My cancer can be measured or has been completely removed by surgery.
Select...
It has been over 21 days since my last treatment with interleukins, interferons, or cytokines.
Select...
My kidney function is good based on tests.
Select...
It has been more than 42 days since I completed any cellular therapy.
Select...
My bilirubin levels are within the normal range for my age.
Select...
My heart pumps well, with an ejection fraction over 50%.
Select...
My kidney function is normal.
Select...
I haven't taken any cancer drugs that lower blood counts in the last week.
Select...
I had my own stem cell infusion more than 42 days ago.
Select...
I have recovered from previous cancer treatments and meet the required waiting period.
Select...
My disease can be measured or evaluated.
Select...
I have waited the required time after my radiation therapy before joining this trial.
Select...
I am physically able to care for myself.
Select...
I am mostly self-sufficient and can carry out daily activities.
Select...
My osteosarcoma has returned or worsened after treatment and cannot be cured.
Select...
My heart is functioning well.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~beginning of study to end of study, up to 4 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and beginning of study to end of study, up to 4 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Assessment of Dose-Limiting Toxicities of Losartan and Sunitinib Combination
Maximally Tolerated Dose of Losartan and Sunitinib
Recommended Phase 2 Dose of Losartan and Sunitinib
Secondary outcome measures
Pharmacodynamics of Losartan and Sunitinib in Pediatric and Adult Patients: CCL2-Mediated Chemotactic Index
Pharmacodynamics of Losartan and Sunitinib in Pediatric and Adult Patients: CCR2+ Monocyte Population
Pharmacodynamics of Losartan and Sunitinib in Pediatric and Adult Patients: Plasma CCL2 Levels
+4 more

Side effects data

From 2021 Phase 4 trial • 227 Patients • NCT02188121
43%
Laboratory values outside normal range
23%
Psychiatric Hospitalization
6%
Medical Hospitalization
2%
Elevated creatine kinase level
1%
Muscle pain
1%
Hypotension
1%
Dehydration
1%
Leukemia
1%
Placed on Lithium while on Losartan
100%
80%
60%
40%
20%
0%
Study treatment Arm
Statin and/or Angiotensin Receptor Blocker
Usual Treatment

Trial Design

1Treatment groups
Experimental Treatment
Group I: Dose Escalation and ExpansionExperimental Treatment2 Interventions
Part 1: This is a study escalating doses (Dose level 1-3) of losartan on a continuous daily dosing schedule and sunitinib (escalating on dose level 4) on a daily dosing with 4 weeks on, 2 weeks off. A cycle of therapy is 6 weeks (42 days).Dosing will be performed based on body surface area (BSA). This portion of the study uses a 3+3 design (i.e. cohort sizes of 3 patients for the first and second cohort at each dose level). Part 2: Once the Maximally Tolerated Dose (MTD) has been determined, 12 patients will enroll to the expansion cohort. These patients will receive the MTD as long as less then 33% of patients experience dose-limiting toxicities.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Losartan
2003
Completed Phase 4
~3000
Sunitinib
2014
Completed Phase 3
~4380

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,729 Previous Clinical Trials
2,143,337 Total Patients Enrolled
Kelly Faulk, MDPrincipal InvestigatorChildren's Hospital Colorado
Carrye Cost, MDPrincipal InvestigatorChildren's Hospital Colorado
1 Previous Clinical Trials
2 Total Patients Enrolled

Media Library

Losartan (Angiotensin II Receptor Blocker) Clinical Trial Eligibility Overview. Trial Name: NCT03900793 — Phase 1
Osteosarcoma Research Study Groups: Dose Escalation and Expansion
Osteosarcoma Clinical Trial 2023: Losartan Highlights & Side Effects. Trial Name: NCT03900793 — Phase 1
Losartan (Angiotensin II Receptor Blocker) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03900793 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What can be said about the security of Losartan for individuals?

"Losartan's safety is only partially understood and has thus been rated a 1 on our scale. This reflects the fact that this trial is currently in Phase 1, indicating limited clinical evidence regarding both efficacy and safety."

Answered by AI

What medical condition is Losartan generally utilized to address?

"Losartan is typically prescribed for the treatment of left ventricular hypertrophy, however it has shown to be efficacious in treating a range of other illnesses such as proteinuria, gastrointestinal stromal tumors, and ischemia."

Answered by AI

Could I meet the qualifications necessary to join this clinical experiment?

"To qualify for this research study, patients must have osteosarcoma and be between 10 to 40 years old. There is space in the trial for 41 participants."

Answered by AI

Is enrollment for the trial still available?

"Affirmative. Evidence on clinicaltrials.gov attests to the fact that this trial is actively enrolling patients; it was originally posted in August of 2019 and last amended in May of 2022. An estimated 41 participants need to be recruited from two separate medical centers."

Answered by AI

Have there been any other experiments involving Losartan in the past?

"The first trial exploring losartan occurred at DuPage Medical Group - Joliet in 2006. Since then, the medication has been tested 413 more times and is currently being evaluated by 62 active trials, many of which are located near Atlanta, Georgia."

Answered by AI

What objectives has this medical experiment been designed to accomplish?

"This medical trial, which will run for up to 4 years and be closely monitored, aims to determine the Maximum Tolerated Dose of Losartan and Sunitinib. The secondary objectives include determining Progression Free Survival with irRECIST criteria, assessing Antitumor Activity through Disease Control Rate (DCR) using RECIST 1.1 criteria, and measuring Pharmacodynamics via a CCL2-Mediated Chemotactic Index in a monocyte mitigation assay."

Answered by AI

How many participants are being enrolled in this research trial?

"Yes, this trial is still enrolling patients. Per the information found on clinicaltrials.gov, it was initially posted on August 22nd 2019 and edited lastly on May 12th 2022; 41 participants are required across two sites."

Answered by AI

Is this trial open to adults of advanced age?

"Following the requirements for this medical experiment, participants must be aged 10 to 40 years old."

Answered by AI
~14 spots leftby Aug 2026