Imaging Perfusion Restrictions From Extracellular Solid Stress - An Open-label Losartan Study (NCT03951142) | Clinical Trial Compass
UnknownPhase 2
Imaging Perfusion Restrictions From Extracellular Solid Stress - An Open-label Losartan Study
Norway165 participantsStarted 2019-10-01
Plain-language summary
An open-label, single institutional phase II trial of losartan in patients with primary and metastatic brain tumors with an individual stepped-wedge, randomized, assessor-blinded, dose-finding design on three indications.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. A histologically confirmed intracranial glioblastoma, WHO grade 4 (Study A), or a minimum of one radiographically confirmed metastasis to the brain from a primary non-small-cell lung cancer (Study B)
✓. Ability to undergo an MRI exam, including administration of a standard clinical dose of an MRI-specific contrast agent of gadolinium or similar
✓. Measurable intracranial disease (Study A - recurrent glioblastoma, and Study B only), defined as at least one lesion that can be accurately measured in at least one dimension as ≥10 mm with MRI
✓. Age ≥18 years
✓. Eligible for administration of the active substance (losartan) in concordance with study protocol, the criteria of the product label (Cozaar) and deemed fit for trial by the treating physician.
✓. An ECOG performance status of ≤2 or equivalent KPS of ≥60%
✓. Life expectancy from start of treatment of more than 3 months
✓. Previous history of neurosurgical procedure (Study A - only) or stereotactic radiosurgery and immunotherapy (Study B) at time of study inclusion
Exclusion criteria
✕. Hypersensitivity to the active substance (losartan) or to any of the excipients
✕. Patients on antihypertensive agents that cannot be substituted with losartan.
✕. Patients on medication that may induce hypotension and/or increase potassium levels and/or cause metabolism-related pharmacokinetic drug-drug interactions with losartan. If medication with such effects can safely be discontinued or replaced, the patient can be included in the study after a washout period before baseline.
What they're measuring
1
Relative cerebral blood flow by MRI
Timeframe: Study AR: Baseline, Day 14-16, Day 28-30, Day 42-44. Study arm AN: Baseline, Day 14-16, Day 28-30, Day 42-44. Study arm BM: Baseline, Day 90±7, Day 180±7, Day 270±7
2
Relative solid stress by MRI
Timeframe: Study AR: Baseline, Day 14-16, Day 28-30, Day 42-44. Study arm AN: Baseline, Day 14-16, Day 28-30, Day 42-44. Study arm BM: Baseline, Day 90±7, Day 180±7, Day 270±7
✕. Patients with hepatic or renal impairment of any reason
✕. Patients with symptomatic hypotension of any reason
✕. Patients with primary hyperaldosteronism
✕. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption should not take this medicine
✕. Inadequate recovery from toxicity and/or complications of previous therapy as determined by the treating physician