A Phase I Dose-finding Study of E7050 Administered Orally 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.
1. Subjects with a histological or cytological diagnosis of solid tumors or gastric
2. Subjects who have progressed after treatment with approved therapies or for whom
there are no standard effective therapies available.
3. Subjects with adequate organ function.
4. Patients who have no carryover of effect from prior therapy or no adverse drug
reactions (excluding alopecia) that may affect the safety evaluation of the
5. Subjects with Performance Status (PS) 0-1 established by Eastern Cooperative Oncology
1. Subjects who have brain metastases with clinical symptoms or which requires
2. Subjects with the serious complications or disease history.
3. Subjects who cannot take oral medication.
4. Subjects who need continuous use of drugs or foods that strongly inhibit or induce
CYP3A4/5 or CYP2D6 during the study period.
5. Female subjects who are pregnant or breast-feeding.
Type of Study:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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)
Outcome Time Frame:
During the Run-in Phase and the first 5 weeks of treatment
Oncology Clinical Development Section. JAC PCU. Eisai Co., Ltd.
Japan: Ministry of Health, Labor and Welfare
- Solid Tumors
- Gastrointestinal Cancer