Two-centre, open-label, non-randomized, dose-finding phase I study to determine the MTD of E7107 administered by intravenous infusion (as a 2-5 minutes bolus) on days 1, 8 and 15 every 28 days in patients with solid tumors, for whom therapy of proven efficacy does not exist or is not longer effective.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
E7107 administered by intravenous infusion (as a 2-5 minutes bolus) on days 1, 8 and 15 every 28 days.
Department of Medical Oncology, Erasmus University Medical Centre
Rotterdam, Netherlands
Medical Oncology Service. Vall d'Hebron University Hospital
Barcelona, Spain
To determine MTD of E7107. Safety and tolerability.
Time frame: Every six weeks.
Pharmacokinetics of E7107. Evaluation of anti-tumor activity. To investigate potential biomarkers of pharmacodynamic effect.
Time frame: Every 21 days.
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