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A Phase I Dose-finding Study of E7050 Administered Orally to Patients With Advanced Solid Tumors.

Phase 1
20 Years
74 Years
Not Enrolling
Solid Tumors

Thank you

Trial Information

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.

Inclusion Criteria

Inclusion criteria:

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
investigational drug.

5. Subjects with Performance Status (PS) 0-1 established by Eastern Cooperative Oncology
Group (ECOG).

Exclusion criteria:

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:


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 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

Safety Issue:


Principal Investigator

Takashi Sawada

Investigator Role:

Study Director

Investigator Affiliation:

Oncology Clinical Development Section. JAC PCU. Eisai Co., Ltd.


Japan: Ministry of Health, Labor and Welfare

Study ID:




Start Date:

October 2009

Completion Date:

June 2011

Related Keywords:

  • Solid Tumors
  • Cancer
  • Gastrointestinal Cancer
  • Neoplasms