Status:
COMPLETED
A Study of E7050 Administered Orally to Patients With Advanced Solid Tumors
Lead Sponsor:
Eisai Co., Ltd.
Conditions:
Solid Tumors
Eligibility:
All Genders
20-74 years
Phase:
PHASE1
Brief Summary
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 t...
Detailed Description
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 t...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Subjects with a histological or cytological diagnosis of solid tumors or gastric cancer.
- Subjects who have progressed after treatment with approved therapies or for whom there are no standard effective therapies available.
- Subjects with adequate organ function.
- 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 investigational drug.
- Subjects with Performance Status (PS) 0-1 established by Eastern Cooperative Oncology Group (ECOG).
- Exclusion criteria:
- Subjects who have brain metastases with clinical symptoms or which requires treatment.
- Subjects with the serious complications or disease history.
- Subjects who cannot take oral medication.
- Subjects who need continuous use of drugs or foods that strongly inhibit or induce CYP3A4/5 or CYP2D6 during the study period.
- Female subjects who are pregnant or breast-feeding.
Exclusion
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00921869
Start Date
October 1 2009
End Date
June 1 2011
Last Update
December 26 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Kashiwa-shi, Chiba, Japan