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
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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) of each 42-day cycle according to assigned dose level. Dosing will be performed based on weight in kilograms and rounded to the nearest 12.5 mg (half of 25 mg tablet). Dose Levels 1 and 2 are closed to enrollment. Dose level 1 does not exceed 50mg daily. Dose level 2 does not exceed 100mg daily. Dose levels 3 and 4 do not exceed 150mg total daily. Doses should be taken at approximately the same time daily and patients should fast for at least 4 hours prior to and 1 hour after the morning dose. No fasting is required for evening dose.
  • 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

First listed
Apr 3, 2019
Start date
Aug 26, 2019
Status verified
Aug 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
    Participants receive losartan in combination with sunitinib in 42-day treatment cycles. During Part A, participants are enrolled using a standard 3+3 dose-escalation design across up to four dose levels. Dose Levels 1 and 2 utilized once-daily losartan dosing and are closed to enrollment. Active enrollment occurs at Dose Levels 3 and 4, where losartan is administered twice daily and sunitinib is administered daily for 4 weeks followed by a 2-week rest period. Following determination of the maximally tolerated dose (MTD), 12 additional participants are enrolled into an expansion cohort to further evaluate safety, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity.

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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