Losartan + Sunitinib in Treatment of Osteosarcoma

Part of paid clinical trials in Los Angeles, California.

Sponsor
University of Colorado, Denver
Study ID
NCT03900793
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Osteosarcoma

Eligibility Criteria

Sex
ALL
Age
10 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Losartan — DRUG
    Losartan will be administered orally daily on days 1-42 (6 weeks) with dose level assignments. Dosing will be performed based on weight in kilograms and rounded to the nearest 12.5 mg (half of 25 mg tablet). Dose level 1 dosing will not exceed 50 mg daily, dose level 2 dosing will not exceed 100 mg daily, and dose level 3 dosing will not exceed 150 mg total daily (75 mg twice daily). Doses should be taken at approximately the same time daily and patients should fast for at least 4 hours prior to dosing
  • Sunitinib — DRUG
    Sunitinib will be administered orally daily on days 1-28 (4 weeks), followed by 14-day rest period (2 weeks). Dosing will be performed based on body surface area (BSA) in mg/m2. Sunitinib is given as capsules or liquid formulation. Doses should be taken at approximately the same time daily.

Study Details

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.

Key Dates

Start date
Aug 26, 2019
Status verified
Jun 2026
Primary completion
Aug 1, 2027
Completion
Aug 1, 2029

Study Design

Enrollment
41 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation and Expansion
    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.

Primary Outcome Measure

Assessment of Dose-Limiting Toxicities of Losartan and Sunitinib Combination [ Time Frame: Beginning of study to end of study, up to 4 years ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Children's Hospital Los AngelesLos AngelesCalifornia90027
Fariba Navid, MD
[email protected]
323-361-4624
Children's Hospital ColoradoAuroraColorado80045
Kelly Faulk, MD
[email protected]
Kelly Faulk, MD (PRINCIPAL_INVESTIGATOR)
University of Colorado HospitalAuroraColorado80045
Kelly Faulk, MD, MSCS
[email protected]
1-720-777-6503
Children's Hospital of AtlantaAtlantaGeorgia30322
Thomas Cash, MD
[email protected]
Thomas Cash, MD (PRINCIPAL_INVESTIGATOR)

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Children's Hospital Los Angeles· Los Angeles, CAChildren's Hospital Colorado· Aurora, COUniversity of Colorado Hospital· Aurora, COChildren's Hospital of Atlanta· Atlanta, GA

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