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Losartan + Sunitinib for Osteosarcoma
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2021 Phase 4 trial • 227 Patients • NCT02188121Trial Design
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Who is running the clinical trial?
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- My platelet count is above 75,000 and I haven't had a transfusion in the last week.I have received previous treatments for my condition.It's been over 14 days since my last long-acting growth factor dose or 7 days for a short-acting one.I am not taking, nor have I taken in the last week, any strong medication that affects enzyme activity.My heart condition does not severely limit my daily activities.I have not had major surgery in the last 14 days.My osteosarcoma is not just on the surface or outer layer of the bone.My condition is currently active.My blood tests show my bone marrow is working well.It's been over 3 weeks since my last chemotherapy that affects my bone marrow.I have no history of serious heart problems or strokes.I am not on medications that affect heart rhythm.I have not received heart radiation over 15 Gy.My blood pressure is controlled with one or no medication.I am taking other medications.I do not have active brain metastases but had treated ones over 3 months ago with no recurrence.I have not received heart radiation exceeding 15 Gy.I agree to use two forms of birth control or practice true abstinence during and 3 months after the study.I am older than 10 years.My thyroid condition is stable on my current medication.I can take pills by mouth or through a feeding tube.I haven't taken any systemic corticosteroids in the last 14 days.It's been over 21 days since my last antibody treatment and any side effects are mild.It has been more than 14 days since my last corticosteroid dose.My liver is working well.My cancer can be measured or has been completely removed by surgery.It has been over 21 days since my last treatment with interleukins, interferons, or cytokines.My kidney function is good based on tests.I do not have any uncontrolled bleeding disorders or significant active bleeding.I had a blood clot in my lung or another serious clot more than 28 days ago and am stable now.I am not currently taking any cancer treatment drugs.It has been more than 42 days since I completed any cellular therapy.My bilirubin levels are within the normal range for my age.My heart pumps well, with an ejection fraction over 50%.My kidney function is normal.I haven't taken any cancer drugs that lower blood counts in the last week.I had my own stem cell infusion more than 42 days ago.I have recovered from previous cancer treatments and meet the required waiting period.My disease can be measured or evaluated.I have waited the required time after my radiation therapy before joining this trial.I am physically able to care for myself.I am mostly self-sufficient and can carry out daily activities.My osteosarcoma has returned or worsened after treatment and cannot be cured.My heart is functioning well.
- Group 1: Dose Escalation and Expansion
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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."
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."
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."
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."
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