A Study of E7080 in Subjects With Advanced Thyroid Cancer

July 21, 2020 updated by: Eisai Co., Ltd.

A Phase 2 Study of E7080 in Subjects With Advanced Thyroid Cancer

This study is to evaluate the safety, efficacy, and pharmacokinetics of E7080 when orally administered once daily (QD) in subjects with advanced thyroid cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

51

Phase

  • Phase 2

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

  • Japan
    • Chiba
      • Kashiwa, Chiba, Japan
    • Hyogo
      • Kobe, Hyogo, Japan
    • Tokyo
      • Koto-ward, Tokyo, Japan

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

  1. Histologically or clinically diagnosed with thyroid cancer
  2. Eastern Cooperative Oncology Group Performance Status (ECOG-PS) 0-2
  3. Adequate laboratory values/organ function tests

Exclusion criteria

Participants with following complication or disease history

  1. Brain metastasis
  2. Systemic severe infection
  3. Significant cardiovascular impairment
  4. QTc greater than 480 milliseconds
  5. Active hemoptysis
  6. Bleeding or thrombotic disorders
  7. Having greater than 1+ proteinuria on urine dipstick testing will undergo 24 hour urine collection for quantitative assessment of proteinuria
  8. Gastrointestinal malabsorption or any other condition in the opinion of the investigator that might affect the absorption of E7080
  9. Major surgery within 3 weeks before enrollment
  10. With co-existing effusion requiring drainage

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: E7080
Drug: E7080 capsule
E7080 is administered as continuous once daily dosing in an uncontrolled manner

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time Frame: Screening visit to 30 days after the last dose of study drug, or assessed up to 3 years
Only TEAEs are included in the summary. For detailed list of adverse events (AEs), see the AE section. For each participant, only one TEAE in the same category was counted and for multiple TEAEs with different Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v 4.0) grades, only the event with the highest grade was reported. All AEs were graded using CTCAE v 4.0, except for alopecia and infertility.
Screening visit to 30 days after the last dose of study drug, or assessed up to 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free Survival (PFS)
Time Frame: From first date of study treatment until progression of disease or date of death from any cause, whichever comes first, assessed up to 34 months
PFS was defined as the time from (1) the date of randomization to the date of first documentation of disease progression based on Investigator and Independent Review Committee assessments according to Response Evaluation Criteria In Solid Tumors version 1.1 (RECIST v1.1), or (2) death, whichever came first. Disease progression for the MTC group was measured using computed tomography (CT) or magnetic resonance imaging (MRI) on targeted tumors. Disease progression per RECIST v1.1 was defined as at least a 20 percent (%) relative increase and 5 millimeter (mm) absolute increase in the sum of diameters of target lesions (taking as reference the smallest sum on study), recorded since the treatment started or the appearance of 1 or more new lesions. Summarized by the Kaplan-Meier method using median time with 95% confidence interval (CI).
From first date of study treatment until progression of disease or date of death from any cause, whichever comes first, assessed up to 34 months
Overall Survival (OS)
Time Frame: From study start until date of death from any cause, assessed up to 34 months
OS was defined as the time from the date of first dose of study treatment to the date of death from any cause. If death was not observed for a participant, the survival time was censored at the date the participant was last known alive or the data cutoff date (whichever occurred first). Summarized by the Kaplan-Meier method using median time with 95% CI.
From study start until date of death from any cause, assessed up to 34 months
Best Overall Response (BOR)
Time Frame: Date of first dose of study treatment to CR, PR, SD, PD, or NE, assessed up to 34 months
BOR was defined as the best response observed between the time of first dose and the study completion, assessed by either of complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD), or not evaluable (NE). Tumor assessment was performed by the investigator using RECIST 1.1. The CR and PR were determined only when these responses met each criterion even after 28 days from the time observed. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD was defined as greater than or equal to 7 weeks for DTC and MTC, greater than or equal to 3 weeks for ATC.
Date of first dose of study treatment to CR, PR, SD, PD, or NE, assessed up to 34 months
Objective Response Rate (ORR)
Time Frame: Date of CR or PR to date of PD or death (whichever was first), assessed up to 34 months
ORR was defined as the percentage of participants who had BOR of CR or PR. Tumor assessment was performed by the investigator using RECIST 1.1. ORR based on the investigator assessment was provided with a corresponding exact 95% CI which was calculated using exact method of binomial distribution.
Date of CR or PR to date of PD or death (whichever was first), assessed up to 34 months
Disease Control Rate (DCR)
Time Frame: Date of CR, PR, or SD to date of PD or death (whichever was first), assessed up to 34 months
The DCR was defined as the percentage of participants who had BOR of CR, PR, or SD. Tumor assessment was performed by the investigator using RECIST 1.1. DCR based on the investigator assessment was provided with a corresponding exact 95% CI which was calculated using exact method of binomial distribution.
Date of CR, PR, or SD to date of PD or death (whichever was first), assessed up to 34 months
Clinical Benefit Rate (CBR)
Time Frame: Date of CR, PR, or dSD to date of PD or death (whichever was first), assessed up to 34 months
The CBR was defined as the percentage of participants who had BOR of CR, PR, or durable SD (dSD). Tumor assessment was performed by the investigator using RECIST 1.1. Durable stable disease was defined as SD lasting greater than or equal to 23 weeks for DTC and MTC, greater than or equal to 11 weeks for ATC. A 95% CI was calculated using exact method of binomial distribution.
Date of CR, PR, or dSD to date of PD or death (whichever was first), assessed up to 34 months

Collaborators and Investigators

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

Sponsor

Eisai Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

September 3, 2012

Primary Completion (ACTUAL)

July 9, 2015

Study Completion (ACTUAL)

October 1, 2015

Study Registration Dates

First Submitted

September 7, 2012

First Submitted That Met QC Criteria

November 19, 2012

First Posted (ESTIMATE)

November 20, 2012

Study Record Updates

Last Update Posted (ACTUAL)

August 14, 2020

Last Update Submitted That Met QC Criteria

July 21, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E7080-J081-208

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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