A Phase I Study of E7050 in Subjects With Solid Tumors

Gastric Cancer Clinical Trial

Official title:

A Phase I Study of E7050 in Subjects With Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01428141
• Other study ID #: E7050-J081-110
• Status: Completed
• Phase: Phase 1
• First received: September 1, 2011
• Last updated: February 13, 2014
• Start date: September 2011
• Est. completion date: July 2013

Study information

• Verified date: February 2014
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: July 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 74 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Gastric Cancer
• Solid Tumor

Intervention

Drug:
• E7050
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes