Phase 1 Study of E7090 in Subjects With Solid Tumor

September 23, 2021 updated by: Eisai Co., Ltd.

A Phase 1 Study of E7090 in Subjects With Solid Tumor

This is a Phase 1 study of E7090 in subjects with advanced solid tumors. This study will be conducted in 2 parts:

  1. Part 1 will be the dose escalation portion of this study to determine the maximum tolerated dose in subjects with solid tumors, and
  2. Part 2 will comprise cohort expansions to further characterize the safety and tolerability of E7090 and to assess preliminary efficacy of E7090 in subjects with solid tumors characterized by genetic abnormalities in FGF/FGFR pathway.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Chiba, Japan
        • Eisai Trial Site #1
      • Fukuoka, Japan
        • Eisai Trial Site #1
      • Kyoto, Japan
        • Eisai Trial Site #1
      • Osaka, Japan
        • Eisai Trial Site #1
      • Osaka, Japan
        • Eisai Trial Site #2
      • Osaka, Japan
        • Eisai Trial Site #3
    • Aichi
      • Nagoya, Aichi, Japan
        • Eisai Trial Site #1
    • Chiba
      • Kashiwa, Chiba, Japan
        • Eisai Trial Site #1
    • Ehime
      • Matsuyama, Ehime, Japan
        • Eisai Trial Site #1
    • Hokkaido
      • Sapporo, Hokkaido, Japan
        • Eisai Trial Site #1
    • Hyogo
      • Amagasaki, Hyogo, Japan
        • Eisai Trial Site #1
    • Ibaraki
      • Tsukuba, Ibaraki, Japan
        • Eisai Trial Site #1
    • Kanagawa
      • Kawasaki, Kanagawa, Japan
        • Eisai Trial Site #1
      • Yokohama, Kanagawa, Japan
        • Eisai Trial Site #1
    • Niigata
      • Chuo-ku, Niigata, Japan
        • Eisai Trial Site #1
    • Saitama
      • Kitaadachi, Saitama, Japan
        • Eisai Trial Site #1
    • Tokyo
      • Chuo-Ku, Tokyo, Japan
        • Eisai Trial Site #1
      • Koto-ku, Tokyo, Japan
        • Eisai Trial Site #1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria: Part 1and Part 2

  1. Provide written informed consent
  2. Male or female subjects age >= 20 years at the time of informed consent
  3. Subjects with a histological and/or cytological diagnosis of solid tumor
  4. Subjects who failed standard therapies, or for which no appropriate treatment is available.
  5. Subjects with Performance Status (PS) score of 0-1 established by Eastern Cooperative Oncology Group (ECOG)
  6. Subjects who are expected to survive for 3 months or longer after starting administration of the investigational drug.

    Inclusion Criteria: Part 2 only

  7. Subjects with tumor expressing genetic abnormality in FGF/FGFR (fibroblast growth factor/ fibroblast growth factor receptor)pathway.

Exclusion criteria

  1. Patients with brain metastasis who have clinical symptoms or requiring treatment.
  2. Medical history of clinically significant cardiovascular impairment
  3. Concomitant systemic infection requiring medical treatment
  4. Effusion requiring drainage
  5. Known intolerance to the study drug (or any of excipients)
  6. Subjects whose toxicity of previous treatment has not recovered to Grade 1 or lower (except for alopecia).
  7. Inability to take oral medication, or malabsorption syndrome, or any other uncontrolled gastrointestinal condition (e.g., nausea, diarrhea, or vomiting) that might impair the bioavailability of E7090.
  8. Psychiatric disorder (e.g., alcohol or drug dependency) judged to be ineligible for study entry by the investigator or subinvestigator
  9. Females who are pregnant or breastfeeding
  10. Any subjects who are judged by the principal investigator or the other investigators to be inappropriate as subjects in this clinical study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: E7090 Arm
Oral, starting dose 1 mg once a day, dose escalation in part 1. Cycle 0 is for 7 days. For Cycle 1 and onward, each cycle is 28 days long. The Cycle 0 is set up for PK analysis of a single dose of E7090. In the following Cycle 1, subjects will be administered E7090 QD, and the PK and safety will be assessed for 28 days. One or two doses may be selected from part 1 for Part 2. E7090 will be administered continuously once a daily. Subjects can continue treatment unless they meet discontinuation criteria.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability of E7090 as a measure of Adverse Events/ Serious Adverse Events
Time Frame: Upto 30 days after last administration of drug
Upto 30 days after last administration of drug

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Best Overall Response (BOR) in targeted population
Time Frame: From screening until the date of discontinuation, assessed up to 100 months.
Tumor assessment (target lesion, non-target lesion, and presence or absence of new lesion) will be performed based on RECIST v1.1 (Response Evaluation Criteria In Solid Tumors). Tumor marker will also be measured. FDG-PET CT (fluorodeoxyglucose- Positron emission tomography computed tomography) will also be evaluated. Best overall response are complete response (CR), partial response (PR), stable disease (SD), progression of disease (PD), and not evaluable (NE), where SD have to be achieved at >= 7 weeks after first dose.
From screening until the date of discontinuation, assessed up to 100 months.
Objective Response Rate (ORR)
Time Frame: From screening until the date of discontinuation, assessed up to 100 months.
ORR is defined as a proportion of subjects with BOR of CR or PR.
From screening until the date of discontinuation, assessed up to 100 months.
Disease Control Rate (DCR)
Time Frame: From screening until the date of discontinuation, assessed up to 100 months.
DCR is defined as the proportion of subjects who with BOR of CR, PR or SD.
From screening until the date of discontinuation, assessed up to 100 months.
Progression- Free Survival (PFS)
Time Frame: From the date of first dose until the first documented date of event (disease progression or death from any cause), assessed up to 100 months.
PFS is defined as the time from the date of first dose to the first documented date of event (disease progression or death from any cause, whichever occurs first).
From the date of first dose until the first documented date of event (disease progression or death from any cause), assessed up to 100 months.
Overall Survival (OS)
Time Frame: From the date of first dose until the date of death from any cause, assessed up to 100 months.
OS is defined as the time from the date of first dose to the date of death from any cause.
From the date of first dose until the date of death from any cause, assessed up to 100 months.
Maximum tolerated Dose (MTD) of E7090 (part 1) and Recommended Dose (RD) for future studies
Time Frame: On day 35
On day 35
Plasma Cmax (maximum concentration) of E7090
Time Frame: On day 36
On day 36
Plasma tmax (Time of maximum concentration) of E7090
Time Frame: On day 36
On day 36
Plasma AUC (Area under the concentration vs time curve) of E7090
Time Frame: On day 36
On day 36
Pharmacokinetics (PK) of Urine (renal clearance)
Time Frame: On day 36
On day 36

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 28, 2014

Primary Completion (Actual)

September 3, 2021

Study Completion (Actual)

September 3, 2021

Study Registration Dates

First Submitted

October 20, 2014

First Submitted That Met QC Criteria

October 23, 2014

First Posted (Estimate)

October 27, 2014

Study Record Updates

Last Update Posted (Actual)

September 28, 2021

Last Update Submitted That Met QC Criteria

September 23, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E7090-J081-101

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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