This is a prospective, open-label, single arm, non-randomized study of CPI-300 in patients with advanced tumors. CPI-300 is administered via intravenous infusion using an accelerated titration method followed by a conventional 3 + 3 study design to identify the maximum tolerated dose (MTD).
Up to 6 dose levels of CPI-300 will be tested. MTD will be defined as the dose associated with a dose limiting toxicity (DLT) in less than or equal to 33% of patients at the dose level tested. Dose limiting toxicity (DLT) is defined as one of the following events occurring from the intravenous injection of CPI-300 within 28 days: * Grade 4 or greater treatment related adverse events * Any Grade 3 or greater treatment related non-hematologic, non-dermatologic toxicity (including nausea, vomiting or diarrhea lasting more than 72 hours) Blood samples will be drawn to determine drug blood concentrations for pharmacokinetic assessment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
17
CPI-300 will be administered via intravenous infusion on Day 1 of a 14-Day cycle
Honor Health Research Institute
Scottsdale, Arizona, United States
Florida Cancer Specialists
Lake Mary, Florida, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Adverse Events
To determine the maximum tolerated dose (MTD), which is defined as the highest dose level at which number of patients reporting a dose limiting toxicity (DLT) is less than or equal to 33%
Time frame: 28 days
Clinical Benefit
To assess clinical benefit by response rate and resolution of symptoms, which will be reported as response rate (%)
Time frame: 28 Days and additional CPI-300 treatments till disease progression or intolerability
Adverse Effect
To assess adverse effect as either treatment-related or non-treatment-related as defined by CTCAE
Time frame: 28 Days and additional CPI-300 treatment till disease progression or intolerability
Maximum Plasma Concentration (Cmax)
To evaluate maximum plasma concentration (Cmax) of CPI-300 in patients tested
Time frame: 8 Days
Area Under the Curve (AUC)
To evaluate area under the curve (AUC) of CPI-300 in patients tested
Time frame: 8 Days
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