A Study of E7080 in Subjects With Solid Tumor

NCT01268293 | Completed Phase 1 Results

• 1 other identifier: E7080-J081-105
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the tolerability and safety of E7080 up to 24 mg when administered orally on a once daily continuous dose schedule in cycles (4 weeks as 1 cycle) in subjects with solid tumors

Conditions

Cancer

Keywords

Cancer

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Dose Limiting Toxicity (DLT)

  Up to 4 weeks

• Number of Participants With Adverse Events

  Treatment emergent adverse events (AEs) and serious adverse events (SAEs) were evaluated by determining the AE grade according to Common Terminology Criteria for Adverse Events \[CTCAE\] version 4.0, laboratory tests, vital signs (blood pressure \[mm Hg\], heart rate \[beats per minute\], body temperature \[degree C\], and body weight \[kg\]), 12-lead electrocardiograms (ECGs; heart rate \[bpm\], QT \[msec\] and QTc \[msec\]) and Eastern Cooperative Oncology Group performance status (ECOG-PS).

  Until participants met discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent or up to 19 cycles (1 cycle = 28 days).

Study Arms (1)

1

EXPERIMENTAL

Drug: E7080

Interventions

E7080 DRUG

This arm will be a dose-escalation evaluation of 9-18 subjects to investigate the tolerability and safety of E7080 up to 24 mg when administered orally on a once daily continuous dose schedule in cycles (4 weeks as 1 cycle). Administration of the study drug can continue until subjects meet discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent.

1

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with histologically and/or cytologically diagnosis of solid tumor
• Subjects with solid tumor which is resistant to standard anti-tumor therapies, or which no appropriate treatment is available
• Subjects whose toxicity of previous treatment has recovered to Grade 1 or lower toxicity (except for alopecia)
• Subjects who completed previous anti-tumor therapy before at least 4 weeks
• Subjects who are 20 years or older
• Subjects with 0 to 1 of Performance Status
• Subjects agree to be hospitalized for DLT observation
• Subjects with adequate organ functions
• Males and females of childbearing potential must agree to use appropriate contraception from the agreement to 30 days after study drug administration.
• Agree to participate in this study in writing based on voluntary will

You may not qualify if:

• Subjects with brain metastasis accompanying clinical symptoms or requiring treatment
• Subjects with the severe complication or disease history
• Subjects unable to take oral medication.
• Subjects being treated with drugs that strongly inhibit or induce CYP3A4 and that may be possibly used during this study.
• Scheduled for surgery during the projected course of the study.
• Positive for human immunodeficiency virus (HIV antibody) test or positive for hepatitis B surface (HBs antigen) or hepatitis C (HCV antibody) by serum test.
• Subjects who in the view of the investigator are not able to comply with this protocol because of psychiatric or physical diseases including alcoholism or drug addict
• Pregnant or nursing subjects
• Subjects who are participating in another clinical trial.

Sponsors & Collaborators

• Eisai Co., Ltd.: lead

Study Sites (1)

Unknown Facility

Chuo-ku, Tokyo, Japan

Location

MeSH Terms

Conditions

Neoplasms

Interventions

lenvatinib

Results Point of Contact

• Title: Tatsuya Sasaki
• Organization: Eisai Co., Ltd.

81-3-3817-5252

Study Officials

• Tatsuya Sasaki

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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: December 28, 2010
• First Posted: December 30, 2010
• Study Start: February 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: April 1, 2013
• Last Updated: June 22, 2023
• Results First Posted: March 6, 2015

Record last verified: 2016-08

Locations

JP (1)