1. To determine the maximum tolerated dose (MTD) and the dose limiting toxicities (DLTs) of TRK-950 as single agent 2. To establish the dose of TRK-950 recommended for future phase 2 studies
This study is a first-in-human study of TRK-950 in patients with advanced solid tumors and is primarily designed to determine the dose-limiting toxicities (DLT) and maximum tolerated dose (MTD) of TRK-950 administered via intravenous (IV) infusion once weekly for 3 weeks every 28 days in Arm 1. Once enrollment in Arm 1 was completed, two dose schedules will be evaluated in Arm 2 to determine the dosing schedule. Up to six (6) patients will be enrolled respectively. In parallel, to determine anti-tumor activity up to twelve (12) patients will be enrolled in Arm 3.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
38
Intravenously over 60 minutes, on day 1, 8 and 15 of each cycle
Low dose: intravenously over 60 minutes, on day 1, 8, 15 and 22 of each cycle High dose: intravenously over 60 minutes, on day 1 and 15 of each cycle
Low dose: Intravenously over 60 minutes, on day 1, 8, 15 and 22 of each cycle
Mayo Clinic
Phoenix, Arizona, United States
HonorHealth Research Institute
Scottsdale, Arizona, United States
Centre Léon Bérard
Lyon, France
Adverse event
Time frame: through study completion, an average of 1 year
CTCAE version 4.03
Time frame: through study completion, an average of 1 year
Blood pressure (mmHg)
Time frame: through study completion, an average of 1 year
Heart rate (bpm)
Time frame: through study completion, an average of 1 year
Respiratory rate (bpm)
Time frame: through study completion, an average of 1 year
Temperature (°F or °C)
Time frame: through study completion, an average of 1 year
Weight (lbs/kg)
Time frame: through study completion, an average of 1 year
Height (inches/cm)
Time frame: through study completion, an average of 1 year
Karnofsky performance status
Time frame: through study completion, an average of 1 year
Electrocardiogram
Time frame: through study completion, an average of 1 year
Clinical laboratory tests
Time frame: through study completion, an average of 1 year
Area under the concentration curve(AUC)
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Time frame: through study completion, an average of 1 year
Maximum plasma concentration(Cmax)
Time frame: through study completion, an average of 1 year
Time to maximum plasma concentration(Tmax)
Time frame: through study completion, an average of 1 year
Terminal elimination half life(t1/2)
Time frame: through study completion, an average of 1 year
Total body clearance(CL)
Time frame: through study completion, an average of 1 year
Apparent volume of distribution(Vd)
Time frame: through study completion, an average of 1 year
Tumor response rate
Time frame: through study completion, an average of 1 year
Duration of response
Time frame: through study completion, an average of 1 year
Time to progression
Time frame: through study completion, an average of 1 year
Progression free survival
Time frame: through study completion, an average of 1 year