RecruitingPhase 1

Losartan + Sunitinib in Treatment of Osteosarcoma

United States41 participantsStarted 2019-08-26

Plain-language 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.

Who can participate

Age range

10 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive. At least 21 days after the last dose of cytotoxic or myelosuppressive chemotherapy (42 days if prior nitrosourea).
. Anti-cancer agents not known to be myelosuppressive (e.g., not associated with reduced platelet or ANC counts): ≥ 7 days after the last dose of agent.

Exclusion criteria

. Patients who underwent major surgery within 14 days prior to start of treatment are not eligible.
. Patients with uncontrolled coagulopathy or bleeding disorder, or any active bleeding (i.e., gastrointestinal or pulmonary) deemed to be clinically significant by investigator are not eligible.
. Patients with history of pulmonary embolism or significant thromboembolic event with the preceding 28 days. Patients with thromboembolic events \> 28 days before enrollment who are stable on or completed an anticoagulation course are eligible.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Assessment of Dose-Limiting Toxicities of Losartan and Sunitinib Combination

Timeframe: Beginning of study to end of study, up to 4 years

Maximally Tolerated Dose of Losartan and Sunitinib

Timeframe: Beginning of study to end of study, up to 4 years

Recommended Phase 2 Dose of Losartan and Sunitinib

Timeframe: Beginning of study to end of study, up to 4 years

Trial details

NCT IDNCT03900793

SponsorUniversity of Colorado, Denver

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-08-01

Contact for this trial

Kelly Faulk, MD, MSCS

720-777-6503 kelly.faulk@childrenscolorado.org

View on ClinicalTrials.gov More Osteosarcoma trials

Plain-language summary

Who can participate

Age range

10 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive. At least 21 days after the last dose of cytotoxic or myelosuppressive chemotherapy (42 days if prior nitrosourea).
. Anti-cancer agents not known to be myelosuppressive (e.g., not associated with reduced platelet or ANC counts): ≥ 7 days after the last dose of agent.

Exclusion criteria

. Patients who underwent major surgery within 14 days prior to start of treatment are not eligible.
. Patients with uncontrolled coagulopathy or bleeding disorder, or any active bleeding (i.e., gastrointestinal or pulmonary) deemed to be clinically significant by investigator are not eligible.
. Patients with history of pulmonary embolism or significant thromboembolic event with the preceding 28 days. Patients with thromboembolic events \> 28 days before enrollment who are stable on or completed an anticoagulation course are eligible.

What they're measuring

Assessment of Dose-Limiting Toxicities of Losartan and Sunitinib Combination

Timeframe: Beginning of study to end of study, up to 4 years

Maximally Tolerated Dose of Losartan and Sunitinib

Timeframe: Beginning of study to end of study, up to 4 years

Recommended Phase 2 Dose of Losartan and Sunitinib

Timeframe: Beginning of study to end of study, up to 4 years