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A Phase I Study of E7050 in Subjects With Solid Tumors

Phase 1
20 Years
74 Years
Open (Enrolling)
Solid Tumor, Gastric Cancer

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Trial Information

A Phase I Study of E7050 in Subjects With Solid Tumors

Inclusion 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determination of the maximum tolerated dose (MTD)

Outcome Description:

Determination of the MTD of E7050 given orally once 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 Cycle 1 period (the first 5 weeks of treatment)

Safety Issue:


Principal Investigator

Hiroshi Obaishi

Investigator Role:

Study Director

Investigator Affiliation:

Japan/Asia Clinical Research Product Creation Unit, Eisai Co., Ltd.


Japan: Ministry of Health, Labor and Welfare

Study ID:




Start Date:

September 2011

Completion Date:

February 2013

Related Keywords:

  • Solid Tumor
  • Gastric Cancer
  • Cancer
  • Gastrointestinal Cancer
  • Stomach Neoplasms
  • Neoplasms