The purpose of this study is to determine the maximum tolerated dose (MTD), safety, pharmacokinetics (PK), pharmacodynamics (PD) and anti-tumor activity of E7050 when administered orally twice daily to patients with advanced solid tumors.
Phase I, open-label, dose-escalation study to determine the maximum tolerated dose (MTD) of E7050 given orally, twice-daily, in patients with advanced tumors that have progressed following effective therapy.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
16
The starting dose of E7050 will be 50 mg given orally, twice-daily, in patients with advanced tumors that have progressed following effective therapy.
Unnamed facility
Kashiwa-shi, Chiba, Japan
Determination of the MTD of E7050 given orally twice daily. MTD is the highest dose at which no more than 1 out of 6 patients experiences dose-limiting toxicity (DLT)
Time frame: During the Run-in Phase and the first 5 weeks of treatment
Dose-limiting toxicities.
Time frame: During the Run-in Phase and the first 5 weeks of treatment
Incidence and severity of adverse events and their drug relationship.
Time frame: Throughout the entire study
PK of blood and urine
Time frame: During the Run-in Phase, Cycle 1 (28 days) and Day 15 of Cycle 2 for blood; Day 28 of Cycle 1 for urine
Pharmacodynamic (PD) biomarker analysis of blood and tumor tissue samples.
Time frame: During Cycle 1 (28 days) and Day 15 of Cycle 2 for blood; on Day 22 of Cycle 1 for optional tumor biopsies
Best overall tumor response, duration of response and stable disease, assessed by Response Evaluation Criteria in Solid Tumors.
Time frame: Every 4 weeks for complete and partial response; by 7th week for stable disease
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