A Phase I Study of E7050 in Subjects With Solid Tumors

Eisai

Status and phase: Completed; Phase 1

Conditions: Solid Tumor; Gastric Cancer

Treatments: Drug: E7050

Study type: Interventional

Funder types: Industry

Identifiers

NCT01428141

E7050-J081-110

Details and patient eligibility

About

The purpose of this study is to investigate the tolerability, safety, pharmacokinetics (PK), pharmacodynamics (PD) and anti-tumor activity of E7050 when administered orally once daily to patients with advanced solid tumor and gastric cancer.

Enrollment: 18 patients

Sex: All

Ages: 20 to 74 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

1. Aged from 20 to less than 75 years old at the time of obtaining informed consent.
2. Histological or cytological diagnosis of solid tumors.
3. Subjects who have progressed after treatment with approved therapies or for whom there are no standard effective therapies available.
4. Adequate organ function.
5. Subjects 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.
6. Performance Status (PS) 0-1 established by Eastern Cooperative Oncology Group (ECOG).
7. Expected to survive for 3 months or longer after starting administration of the investigational drug.

Exclusion Criteria

1. Females who are pregnant or breastfeeding.
2. Brain metastases with clinical symptoms or which requires treatment.
3. Serious complications or disease history.
4. Subjects who cannot take oral medication.
5. Using antiplatelet/anticoagulant drugs.
6. Continuous using of drugs or foods that strongly inhibit or induce CYP3A4/5 or CYP2D6 during the study period.
7. Scheduled for surgery during the study period.
8. Known to be HIV, HBV or HCV positive.
9. Suffering from psychotic disorder(s) and/or unstable recurrent affective disorder(s) evident by use of anti-psychotics or have had a suicide attempt(s) within approximately the last 2 years.
10. History of drug or alcohol dependency or abuse within 2 years.
11. Presence of a progressive central nervous system (CNS) disease, including degenerative CNS diseases and progressive tumors.
12. Received any other investigational product or device within 4 weeks before administration.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

E7050

Experimental group

Treatment:

Drug: E7050