This trial is a multi-center, open-label, phase I, dose escalation study of PEP02 (liposomal
encapsulated irinotecan) in combination with 5-FU and LV in patients with advanced solid
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Full eligibility criteria for NCT02884128
Ages eligible for Study
20 Years to 70 Years
Genders eligible for Study
Accepts Healthy Volunteers
Histologically or cytologically confirmed solid tumor which was locally advanced or metastatic and had failed to standard chemotherapy or no standard treatment was available
ECOG performance status 0 or 1
With normal organ and marrow function
Have had major surgery, chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or have not recovered from toxicities due to previous treatment
With known or suspicious primary or secondary brain tumors
History of allergic reactions attributed to compounds of similar chemical or biologic composition to PEP02, 5-FU or leucovorin
HBsAg+ or anti-HCV+ patients with splenomegaly (defined as spleen size > 11 cm in CT scan)
Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, and history of symptomatic congestive heart failure of Functional Class II or more (New York Heart Association) and ischemic heart diseases (i.e. myocardial infarction or angina pectoris), cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Pregnant or breast feeding females (a pregnancy test must be performed on all females who are of child-bearing potential before entering the study and the result must be negative)
Had received irinotecan treatment
All locations for NCT02884128
View full eligibility
Tris trial is registered with FDA with number: NCT02884128. The sponsor of the trial is PharmaEngine and it is looking for 16 volunteers for the current phase.
Official trial title: A Multi-Center, Open-Label Phase I Dose-Escalation Study of PEP02 in Combination With 5-fluorouracil (5-FU) and Leucovorin (LV) in Advanced Solid Tumors
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