The purpose of this study is to determine the maximum tolerated dose (MTD) of E7050 given orally in patients with advanced solid tumors.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Oral dosing starting at 100 mg once daily. After the MTD of once daily dosing has been determined, subsequent cohorts will be treated with a divided dosing schedule either twice or three times daily. The starting dose for this schedule will be an appropriate level below the MTD for once daily dosing.
Christie Hospital
Manchester, United Kingdom
Royal Marsden Hospital
Surrey, United Kingdom
Maximum Tolerated Dose: the highest dose at which no more than 1 out of 6 patients experiences Dose Limiting Toxicity (DLT) during Cycle 1.
Time frame: Weekly assessments during the first 4 weeks of treatment.
DLTs and adverse events.
Time frame: Weekly assessments during the first 4 weeks of treatment for DLTs and throughout the study for AEs.
Pharmacokinetics (blood and urine).
Time frame: Weekly assessments of blood during Cycle 1 and every 2 weeks for subsequent cycles and of urine on Day 1 of Cycles 1 and 2.
Pharmacodynamics (blood).
Time frame: Weekly assessments during Cycle 1, every 2 weeks on Cycle 2, and on Day 1 of subsequent cycles.
Best overall tumor response, duration of response and duration of stable disease assessed according to modified RECIST (Response Evaluation Criteria in Solid Tumors).
Time frame: At Screening, between Days 21 and 28 of every even cycle, and at the Final Visit.
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