Pharmacokinetic Study of E7080/Lenvatinib in Chinese Subjects With Solid Tumor

September 27, 2021 updated by: Eisai Co., Ltd.
Study E7080-C086-108 is an open-label, single- and multiple-dose pharmacokinetic (PK) study of lenvatinib (administered orally, once a day [QD]) in Chinese participants with solid tumor. A total of 12 participants will be enrolled to evaluate the PK of 24 milligrams (mg) QD dosing of lenvatinib.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

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

  • China
    • Beijing
      • Beijing, Beijing, China
        • Beijing Cancer Hospital
    • Heilongjiang
      • Harbin, Heilongjiang, China
        • Harbin Medical University Cancer Hospital

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participants with a histological and/or cytological diagnosis of solid tumor
  • Participants with solid tumor that is resistant to standard anti-tumor therapies, or for which no appropriate treatment is available
  • Participants whose toxicity of previous treatment has recovered to Grade 1 or lower (except for alopecia)
  • Participants who have completed previous anti-tumor therapy (such as surgery, radiotherapy) at least 4 weeks before treatment
  • Participants who are 18 years or older at the time of obtaining informed consent
  • Participants with an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 1

  • Participants who meet all of the following items:

    • Hemoglobin ≥9.0 grams per deciliter (g/dL)
    • Neutrophil count ≥1.5×10^3/microliters (µL)
    • Platelet count ≥10×10^4/µL
    • Total bilirubin ≤1.8 milligrams (mg)/dL
    • Aspartate aminotransferase (AST) ≤100 International Units per liter (IU/L)
    • Alanine aminotransferase (ALT) ≤100 IU/L
    • Serum creatinine ≤1.5 mg/dL or creatinine clearance ≥50 milliliters per minute (mL/min). Creatinine clearance will be calculated based on Cockcroft-Gault method using the following formula: Male: (140-age) × weight ÷ (serum creatinine × 72); Female: 0.85 × (140-age) × weight ÷ (serum creatinine × 72).
  • Participants expected to survive for 12 weeks or longer
  • Males and females of childbearing potential must agree to use appropriate contraception from the giving of consent to 30 days after study drug administration. Female participants of childbearing potential must test negative for pregnancy at screening
  • Participants who voluntarily agree to participate in this study in writing

Exclusion Criteria:

  • Participants with brain metastasis accompanied by clinical symptoms or requiring treatment

  • Participants with the following complications or medical history

    1. Systemic severe infections requiring medical treatment

    2. The following cardiovascular diseases

      1. Ischemic cardiac disease or arrhythmia requiring medical treatment
      2. Angina pectoris or myocardial infarction within 24 weeks before enrollment
      3. Corrected QT interval (QTc) greater than 480 milliseconds (msec) (Fridericia's method)
    3. Hemoptysis (fresh blood) ≥ 1/2 teaspoon (2.5 mL) or clinically significant hemorrhagic or thrombotic events within 4 weeks before enrollment
    4. Systolic pressure ≥150 millimeters of mercury (mmHg) and diastolic pressure ≥90 mmHg
    5. If proteinuria is ≥2+ in a qualitative test for urine protein, ≥1.0 grams for 24 hours is accumulated
    6. Complications or surgery (such as malabsorption syndrome, chronic diarrhea, or total gastrectomy) that could significantly influence the absorption of the investigational drug
    7. Have undergone major surgery within 4 weeks before enrollment
    8. Co-existing effusion requiring treatment
  • Participants unable to take oral medication
  • Participants scheduled for surgery during the projected course of the study
  • Participants who test positive for human immunodeficiency virus (HIV antibody), or positive for hepatitis B surface (HBs antigen) or hepatitis C virus (HCV antibody)
  • Participants who have taken lenvatinib before
  • Participants who in the view of the principal investigator or sub-investigator are not able to comply with this protocol because of psychiatric or physical diseases including alcoholism or drug addiction
  • Pregnant or nursing participants
  • Participants who are participating in another clinical trial

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: 24 mg lenvatinib
Participants will receive once daily oral dosing of lenvatinib 24 milligrams (mg)
Drug: lenvatinib
once daily continuous dosing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area under the concentration-time curve over the dosing interval on multiple dosing (AUC[0-τ])
Time Frame: Day 1: pre-dose; 1, 2, 4, and 8 hours post-dose. Day 2: pre-dose (24 hours after first administration). Day 8: pre-dose. Day 15: pre-dose; 1, 2, 4, and 8 hours post-dose. Day 16: pre-dose (24 hours after administration on Day 15)
Blood samples will be collected to determine the plasma lenvatinib concentration at the specified time points. AUC(0-τ) is defined as the area under the concentration-time profile from time zero to the end of the dosing interval at steady state. AUC represents the total drug exposure over a defined period of time.
Day 1: pre-dose; 1, 2, 4, and 8 hours post-dose. Day 2: pre-dose (24 hours after first administration). Day 8: pre-dose. Day 15: pre-dose; 1, 2, 4, and 8 hours post-dose. Day 16: pre-dose (24 hours after administration on Day 15)
Time at which the highest drug concentration occurs at steady-state (tss,max)
Time Frame: Day 1: pre-dose; 1, 2, 4, and 8 hours post-dose. Day 2: pre-dose (24 hours after first administration). Day 8: pre-dose. Day 15: pre-dose; 1, 2, 4, and 8 hours post-dose. Day 16: pre-dose (24 hours after administration on Day 15)
Blood samples will be collected to determine the plasma lenvatinib concentration at the specified time points. tss,max is the time at which the maximum concentration of lenvatinib is observed in the plasma at steady state, which occurs when the rates of drug administration and drug elimination are equal.
Day 1: pre-dose; 1, 2, 4, and 8 hours post-dose. Day 2: pre-dose (24 hours after first administration). Day 8: pre-dose. Day 15: pre-dose; 1, 2, 4, and 8 hours post-dose. Day 16: pre-dose (24 hours after administration on Day 15)
Average steady-state concentration (Css,av)
Time Frame: Day 1: pre-dose; 1, 2, 4, and 8 hours post-dose. Day 2: pre-dose (24 hours after first administration). Day 8: pre-dose. Day 15: pre-dose; 1, 2, 4, and 8 hours post-dose. Day 16: pre-dose (24 hours after administration on Day 15)
Blood samples will be collected to determine the plasma lenvatinib concentration at the specified time points. Css,av is the average concentration of lenvatinib in plasma at the time that a steady state has been achieved, which occurs when the rates of drug administration and drug elimination are equal.
Day 1: pre-dose; 1, 2, 4, and 8 hours post-dose. Day 2: pre-dose (24 hours after first administration). Day 8: pre-dose. Day 15: pre-dose; 1, 2, 4, and 8 hours post-dose. Day 16: pre-dose (24 hours after administration on Day 15)
Minimum observed concentration at steady-state (Css,min)
Time Frame: Day 1: pre-dose; 1, 2, 4, and 8 hours post-dose. Day 2: pre-dose (24 hours after first administration). Day 8: pre-dose. Day 15: pre-dose; 1, 2, 4, and 8 hours post-dose. Day 16: pre-dose (24 hours after administration on Day 15
Blood samples will be collected to determine the plasma lenvatinib concentration at the specified time points. Css,min is the lowest concentration of lenvatinib in plasma at the time that a steady state has been achieved, which occurs when the rates of drug administration and drug elimination are equal.
Day 1: pre-dose; 1, 2, 4, and 8 hours post-dose. Day 2: pre-dose (24 hours after first administration). Day 8: pre-dose. Day 15: pre-dose; 1, 2, 4, and 8 hours post-dose. Day 16: pre-dose (24 hours after administration on Day 15
Maximum observed concentration at steady-state (Css,max)
Time Frame: Day 1: pre-dose; 1, 2, 4, and 8 hours post-dose. Day 2: pre-dose (24 hours after first administration). Day 8: pre-dose. Day 15: pre-dose; 1, 2, 4, and 8 hours post-dose. Day 16: pre-dose (24 hours after administration on Day 15)
Blood samples will be collected to determine the plasma lenvatinib concentration at the specified time points. Css,max is the highest concentration of lenvatinib in plasma at the time that a steady state has been achieved, which occurs when rates of drug administration and drug elimination are equal.
Day 1: pre-dose; 1, 2, 4, and 8 hours post-dose. Day 2: pre-dose (24 hours after first administration). Day 8: pre-dose. Day 15: pre-dose; 1, 2, 4, and 8 hours post-dose. Day 16: pre-dose (24 hours after administration on Day 15)
Area under the concentration-time curve from zero time to time of last quantifiable concentration (AUC[0-t])
Time Frame: Day 1: pre-dose; 1, 2, 4, and 8 hours post-dose. Day 2: pre-dose (24 hours after first administration). Day 8: pre-dose. Day 15: pre-dose; 1, 2, 4, and 8 hours post-dose. Day 16: pre-dose (24 hours after administration on Day 15)
Blood samples will be collected to determine the plasma lenvatinib concentration at various time points. AUC(0-t) is defined as the AUC from time "0" to the time of the last measurable concentration. AUC represents the total drug exposure over a defined period of time.
Day 1: pre-dose; 1, 2, 4, and 8 hours post-dose. Day 2: pre-dose (24 hours after first administration). Day 8: pre-dose. Day 15: pre-dose; 1, 2, 4, and 8 hours post-dose. Day 16: pre-dose (24 hours after administration on Day 15)
Time at which the highest drug concentration occurs (tmax)
Time Frame: Day 1: pre-dose; 1, 2, 4, and 8 hours post-dose. Day 2: pre-dose (24 hours after first administration). Day 8: pre-dose. Day 15: pre-dose; 1, 2, 4, and 8 hours post-dose. Day 16: pre-dose (24 hours after administration on Day 15)
Blood samples will be collected to determine the plasma lenvatinib concentration at the specified time points. Tmax is the time at which the maximum concentration of lenvatinib is observed in plasma after a single dose of lenvatinib.
Day 1: pre-dose; 1, 2, 4, and 8 hours post-dose. Day 2: pre-dose (24 hours after first administration). Day 8: pre-dose. Day 15: pre-dose; 1, 2, 4, and 8 hours post-dose. Day 16: pre-dose (24 hours after administration on Day 15)
Maximum observed concentration (Cmax)
Time Frame: Day 1: pre-dose; 1, 2, 4, and 8 hours post-dose. Day 2: pre-dose (24 hours after first administration). Day 8: pre-dose. Day 15: pre-dose; 1, 2, 4, and 8 hours post-dose. Day 16: pre-dose (24 hours after administration on Day 15)
Blood samples will be collected to determine the plasma lenvatinib concentration at the specified time points. Cmax is the highest concentration of lenvatinib observed in plasma after a single dose of lenvatinib.
Day 1: pre-dose; 1, 2, 4, and 8 hours post-dose. Day 2: pre-dose (24 hours after first administration). Day 8: pre-dose. Day 15: pre-dose; 1, 2, 4, and 8 hours post-dose. Day 16: pre-dose (24 hours after administration on Day 15)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean blood urea nitrogen (BUN) values
Time Frame: until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
Blood samples will be collected to determine the amount of nitrogen in the blood.
until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
Mean creatinine values
Time Frame: until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
Blood chemistry tests will be performed to determine serum creatinine levels. Participants should be in a seated or supine position during blood collection.
until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
Mean albumin values
Time Frame: until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
Blood chemistry tests will be performed to determine serum albumin values. Participants should be in a seated or supine position during blood collection.
until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
Mean cholesterol values
Time Frame: until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
Blood chemistry tests will be performed to determine cholesterol levels. Participants should be in a seated or supine position during blood collection.
until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
Mean lactate dehydrogenase values
Time Frame: until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
Blood chemistry tests will be performed to determine serum lactate dehydrogenase levels. Participants should be in a seated or supine position during blood collection.
until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
Mean total protein values
Time Frame: until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
Blood chemistry tests will be performed to determine total protein levels. Participants should be in a seated or supine position during blood collection.
until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
Mean C-reactive protein (CRP) values
Time Frame: until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
Blood chemistry tests will be performed to determine CRP levels. Participants should be in a seated or supine position during blood collection.
until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
Mean gamma-glutamyl transpeptidase (γ-GTP) values
Time Frame: until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
Blood chemistry tests will be performed to determine γ-GTP levels. Participants should be in a seated or supine position during blood collection.
until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
Mean total bilirubin values
Time Frame: until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
Blood chemistry tests will be performed to determine total bilirubin levels. Participants should be in a seated or supine position during blood collection.
until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
Mean alanine transaminase (ALT) values
Time Frame: until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
ALT is a transaminase enzyme and is commonly measured clinically as a biomarker for liver health. ALT will be summarized as the mean and standard deviation for all participants.
until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
Mean aspartate transaminase (AST) values
Time Frame: until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
AST is a pyridoxal phosphate-dependent transaminase enzyme and is commonly measured clinically as a biomarker for liver health. AST will be summarized as the mean and standard deviation for all participants.
until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
Mean alkaline phosphatase (ALP) values
Time Frame: until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
ALP is a hydrolase enzyme responsible for the dephosphorylation of molecules, including nucleotides, proteins, and alkaloids, and is commonly measured clinically as a biomarker for liver health. ALP will be summarized as the mean and standard deviation for all participants.
until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
Mean body temperature
Time Frame: until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
Body temperature in degrees Celsius will be analyzed from the armpit of the participants. Body temperature will be summarized as the mean and standard deviation for all participants
until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
Mean body weight
Time Frame: until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
Body weight of the participants will be measured in kilograms (kg). It will be summarized as the mean and standard deviation for all participants.
until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
Mean heart rate
Time Frame: until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
Heart rate of the participants will be measured in beats per minute (bpm). It will be summarized as the mean and standard deviation for all participants.
until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
Mean QT values
Time Frame: until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
The QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. QT values will be measured in milliseconds (msec) and will be summarized as the mean and standard deviation for all participants.
until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
Mean QT corrected (QTc) values
Time Frame: until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
The QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. QTc values will be measured in milliseconds (msec) and it will be summarized as the mean and standard deviation for all participants.
until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
Mean QTc corrected using Fridericia's method (QTcF) values
Time Frame: until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
The QT interval is a measure of the time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. QTcF values will be measured in msec and will be summarized as the mean and standard deviation for all participants.
until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
Number of participants with abnormal, clinically significant physical examination findings
Time Frame: until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
Physical examinations will be performed to determine abnormal findings that meet the definition of an AE. Clinical significance will be determined by the Investigator.
until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
Mean calcium values
Time Frame: until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
Blood chemistry tests will be performed to determine calcium levels. Participants should be in a seated or supine position during blood collection.
until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
Mean chloride values
Time Frame: until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
Blood chemistry tests will be performed to determine chloride levels. Participants should be in a seated or supine position during blood collection.
until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
Mean potassium values
Time Frame: until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
Blood chemistry tests will be performed to determine potassium levels. Participants should be in a seated or supine position during blood collection.
until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
Mean sodium values
Time Frame: until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
Blood chemistry tests will be performed to determine sodium levels. Participants should be in a seated or supine position during blood collection.
until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
Mean lymphocyte count
Time Frame: until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
Hematology tests will be performed to determine the lymphocyte count in blood. Participants should be in a seated or supine position during blood collection.
until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
Mean neutrophil count
Time Frame: until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
Hematology tests will be performed to determine the neutrophil count in blood. Participants should be in a seated or supine position during blood collection.
until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
Mean white blood cell (WBC) count
Time Frame: until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
Hematology tests will be performed to determine the WBC count in blood. Participants should be in a seated or supine position during blood collection.
until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
Mean platelet count
Time Frame: until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
Hematology tests will be performed to determine the platelet count in blood. Participants should be in a seated or supine position during blood collection.
until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
Mean hemoglobin values
Time Frame: until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
Hematology tests will be performed to determine the hemoglobin levels in blood. Participants should be in a seated or supine position during blood collection.
until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
Mean red blood cell (RBC) count
Time Frame: until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
Hematology tests will be performed to determine the RBC count in blood. Participants should be in a seated or supine position during blood collection.
until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
Number of participants with any serious adverse event and any non-serious adverse event
Time Frame: until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
An Adverse Event (AE) is any untoward medical occurrence in a clinical investigation participant administered with an investigational product. A serious adverse event (SAE) is any untoward medical occurrence that at any dose: results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions; or is a congenital abnormality/birth defect.
until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
Mean protein in urine values
Time Frame: until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
Urine samples will be collected to determine the amount of protein in the urine.
until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
Mean glucose in urine values
Time Frame: until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
Urine samples will be collected to determine the amount of glucose in the urine.
until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
Mean occult blood in urine values
Time Frame: until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
Urine samples will be collected to determine the amount of microscopic blood in the urine.
until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
Mean systolic blood pressure and diastolic blood pressure values
Time Frame: until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
Blood pressure will be measured after the participant has been sitting.
until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
Mean pulse
Time Frame: until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
Pulse will be measured after the participant has been sitting.
until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)

Collaborators and Investigators

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

Sponsor

Eisai Co., Ltd.

Investigators

  • Study Director: Eisai Medical Information, Eisai Inc.

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)

August 6, 2018

Primary Completion (Actual)

December 24, 2018

Study Completion (Actual)

August 27, 2021

Study Registration Dates

First Submitted

December 31, 2016

First Submitted That Met QC Criteria

December 31, 2016

First Posted (Estimate)

January 4, 2017

Study Record Updates

Last Update Posted (Actual)

September 28, 2021

Last Update Submitted That Met QC Criteria

September 27, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E7080-C086-108

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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