NCT01428141

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2011

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2011

Completed
Same day until next milestone

Study Start

First participant enrolled

September 1, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 2, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

February 14, 2014

Status Verified

February 1, 2014

Enrollment Period

1.3 years

First QC Date

September 1, 2011

Last Update Submit

February 13, 2014

Conditions

Solid TumorGastric Cancer

Keywords

CancerGastrointestinal Cancer

Outcome Measures

Primary Outcomes (1)

  • Determination of the maximum tolerated dose (MTD)

    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).

    During the Run-in Phase and Cycle 1 period (the first 5 weeks of treatment)

Study Arms (1)

E7050

EXPERIMENTAL
Drug: E7050

Interventions

E7050DRUG

Drug: E7050 The starting dose of E7050 will be 400 mg given orally, once-daily, in patients with advanced tumor that have progressed following effective therapy. The study consists of 2 parts: a Tolerability Confirmation Component to confirm the tolerable dose in subjects with solid tumor and an Expansion Component to confirm the safety and to preliminarily assess the anti-tumor activity in subjects with gastric cancer.

E7050

Eligibility Criteria

Age20 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Females who are pregnant or breastfeeding.
  • Brain metastases with clinical symptoms or which requires treatment.
  • Serious complications or disease history.
  • Subjects who cannot take oral medication.
  • Using antiplatelet/anticoagulant drugs.
  • Continuous using of drugs or foods that strongly inhibit or induce CYP3A4/5 or CYP2D6 during the study period.
  • Scheduled for surgery during the study period.
  • Known to be HIV, HBV or HCV positive.
  • 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.
  • History of drug or alcohol dependency or abuse within 2 years.
  • Presence of a progressive central nervous system (CNS) disease, including degenerative CNS diseases and progressive tumors.
  • Received any other investigational product or device within 4 weeks before administration.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Nagoya, Aichi-ken, Japan

Location

Unknown Facility

Kashiwa, Chiba, Japan

Location

Unknown Facility

Sunto, Shizuoka, Japan

Location

MeSH Terms

Conditions

Stomach NeoplasmsNeoplasmsGastrointestinal Neoplasms

Interventions

N-(2-fluoro-4-((2-(4-(4-methylpiperazin-1-yl)piperidin-1-yl)carbonylaminopyridin-4-yl)oxy)phenyl)-N'-(4-fluorophenyl)cyclopropane-1,1-dicarboxamide

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Hiroshi Obaishi

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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 1, 2011

First Posted

September 2, 2011

Study Start

September 1, 2011

Primary Completion

January 1, 2013

Study Completion

July 1, 2013

Last Updated

February 14, 2014

Record last verified: 2014-02

Locations

JP(3)