Solid TumorPhase 1NCT03009292
Pharmacokinetic Study of E7080/Lenvatinib in Chinese Subjects With Solid Tumor
A Phase 1 study testing lenvatinib in people with Solid Tumor, run by Eisai Co., Ltd. at 2 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- lenvatinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesChina
- Study dates
- 6 Aug 2018to 27 Aug 2021
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- Participants with brain metastasis accompanied by clinical symptoms or requiring treatment
- Participants with the following complications or medical history
- Systemic severe infections requiring medical treatment
- The following cardiovascular diseases
- Ischemic cardiac disease or arrhythmia requiring medical treatment
- Angina pectoris or myocardial infarction within 24 weeks before enrollment
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- Corrected QT interval (QTc) greater than 480 milliseconds (msec) (Fridericia's method)
- Hemoptysis (fresh blood) ≥ 1/2 teaspoon (2.5 mL) or clinically significant hemorrhagic or thrombotic events within 4 weeks before enrollment
- Systolic pressure ≥150 millimeters of mercury (mmHg) and diastolic pressure ≥90 mmHg
- If proteinuria is ≥2+ in a qualitative test for urine protein, ≥1.0 grams for 24 hours is accumulated
- Complications or surgery (such as malabsorption syndrome, chronic diarrhea, or total gastrectomy) that could significantly influence the absorption of the investigational drug
- Have undergone major surgery within 4 weeks before enrollment
- 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
Trial locations and contacts
2 sites in 1 country.
China2 sites
Beijing Cancer Hospital
Beijing, Beijing Municipality
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang
About this study
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.
- Conditions
- Solid Tumor
- Being tested
- lenvatinib
- Keywords
- solid tumor, Lenvatinib, pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lenvatinibDrug
once daily continuous dosing
| Study group | Role | What they receive |
|---|---|---|
| 24 mg lenvatinib | Experimental | Participants will receive once daily oral dosing of lenvatinib 24 milligrams (mg) Receives: Drug: lenvatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration-time curve over the dosing interval on multiple dosing (AUC[0-τ])
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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])
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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 outcomes (35)
Mean blood urea nitrogen (BUN) values
Blood samples will be collected to determine the amount of nitrogen in the blood.
Measured: until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
Mean creatinine values
Blood chemistry tests will be performed to determine serum creatinine levels. Participants should be in a seated or supine position during blood collection.
Measured: until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
Mean albumin values
Blood chemistry tests will be performed to determine serum albumin values. Participants should be in a seated or supine position during blood collection.
Measured: until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
Mean cholesterol values
Blood chemistry tests will be performed to determine cholesterol levels. Participants should be in a seated or supine position during blood collection.
Measured: until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
Mean lactate dehydrogenase values
Blood chemistry tests will be performed to determine serum lactate dehydrogenase levels. Participants should be in a seated or supine position during blood collection.
Measured: until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
Mean total protein values
Blood chemistry tests will be performed to determine total protein levels. Participants should be in a seated or supine position during blood collection.
Measured: 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
Blood chemistry tests will be performed to determine CRP levels. Participants should be in a seated or supine position during blood collection.
Measured: 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
Blood chemistry tests will be performed to determine γ-GTP levels. Participants should be in a seated or supine position during blood collection.
Measured: until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
Mean total bilirubin values
Blood chemistry tests will be performed to determine total bilirubin levels. Participants should be in a seated or supine position during blood collection.
Measured: until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
Mean alanine transaminase (ALT) values
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.
Measured: until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
Mean aspartate transaminase (AST) values
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.
Measured: until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
Mean alkaline phosphatase (ALP) values
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.
Measured: until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
Mean body temperature
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
Measured: until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
Mean body weight
Body weight of the participants will be measured in kilograms (kg). It will be summarized as the mean and standard deviation for all participants.
Measured: until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
Mean heart rate
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.
Measured: until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
Mean QT values
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.
Measured: until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
Mean QT corrected (QTc) values
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.
Measured: 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
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.
Measured: 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
Physical examinations will be performed to determine abnormal findings that meet the definition of an AE. Clinical significance will be determined by the Investigator.
Measured: until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
Mean calcium values
Blood chemistry tests will be performed to determine calcium levels. Participants should be in a seated or supine position during blood collection.
Measured: until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
Mean chloride values
Blood chemistry tests will be performed to determine chloride levels. Participants should be in a seated or supine position during blood collection.
Measured: until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
Mean potassium values
Blood chemistry tests will be performed to determine potassium levels. Participants should be in a seated or supine position during blood collection.
Measured: until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
Mean sodium values
Blood chemistry tests will be performed to determine sodium levels. Participants should be in a seated or supine position during blood collection.
Measured: until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
Mean lymphocyte count
Hematology tests will be performed to determine the lymphocyte count in blood. Participants should be in a seated or supine position during blood collection.
Measured: until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
Mean neutrophil count
Hematology tests will be performed to determine the neutrophil count in blood. Participants should be in a seated or supine position during blood collection.
Measured: 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
Hematology tests will be performed to determine the WBC count in blood. Participants should be in a seated or supine position during blood collection.
Measured: until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
Mean platelet count
Hematology tests will be performed to determine the platelet count in blood. Participants should be in a seated or supine position during blood collection.
Measured: until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
Mean hemoglobin values
Hematology tests will be performed to determine the hemoglobin levels in blood. Participants should be in a seated or supine position during blood collection.
Measured: 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
Hematology tests will be performed to determine the RBC count in blood. Participants should be in a seated or supine position during blood collection.
Measured: 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
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.
Measured: until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
Mean protein in urine values
Urine samples will be collected to determine the amount of protein in the urine.
Measured: until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
Mean glucose in urine values
Urine samples will be collected to determine the amount of glucose in the urine.
Measured: 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
Urine samples will be collected to determine the amount of microscopic blood in the urine.
Measured: 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
Blood pressure will be measured after the participant has been sitting.
Measured: until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
Mean pulse
Pulse will be measured after the participant has been sitting.
Measured: until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2017 (estimated)
- Study start6 Aug 2018
- Primary completion24 Dec 2018
- Study completion27 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eisai Medical Information, Study director, Eisai Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03009292
- Sponsor's protocol ID
- E7080-C086-108
- Status last verified
- Mar 2021
- First submitted
- 31 Dec 2016
- Last updated
- 28 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Liu D, Liu L, Shen L, Kubota T, Suzuki T, Ikezawa H, Shiba S, Bai Y. Pharmacokinetic study of lenvatinib in Chinese patients with solid tumors. Future Oncol. 2021 May;17(15):1855-1863. doi: 10.2217/fon-2020-0877. Epub 2021 Jan 21.
PubMed 33474967
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Study of E7080/Lenvatinib in Chinese Subjects With Solid Tumor
- ClinicalTrials.gov ID
- NCT03009292
- Acronym / sponsor ID
- E7080-C086-108
- Conditions
- Solid Tumor
- Keywords
- solid tumor, Lenvatinib, pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Eisai Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Aug 2018 (actual)
- Primary completion
- 24 Dec 2018 (actual)
- Study completion
- 27 Aug 2021 (actual)
- First posted
- 4 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 24 mg lenvatinib | Experimental | Drug: lenvatinibParticipants will receive once daily oral dosing of lenvatinib 24 milligrams (mg) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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
Key exclusion criteria (20 listed)
- Participants with brain metastasis accompanied by clinical symptoms or requiring treatment
- Participants with the following complications or medical history
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lenvatinibonce daily continuous dosing | Drug | 24 mg lenvatinib |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
35 secondary outcomes
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)
Mean creatinine values
Time frame: 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)
Mean cholesterol values
Time frame: 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)
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)
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)
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)
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)
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)
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)
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)
Mean body temperature
Time frame: 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)
Mean heart rate
Time frame: 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)
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)
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)
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)
Mean calcium values
Time frame: 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)
Mean potassium values
Time frame: 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)
Mean lymphocyte count
Time frame: 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)
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)
Mean platelet count
Time frame: 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)
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)
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)
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)
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)
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)
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)
Mean pulse
Time frame: until disease progression, development of unacceptable toxicity, participant requests to discontinue, or withdrawal of consent (up to Day 28)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2021.
- Derived from this study: PubMed 33474967Liu D, Liu L, Shen L, Kubota T, Suzuki T, Ikezawa H, Shiba S, Bai Y. Pharmacokinetic study of lenvatinib in Chinese patients with solid tumors. Future Oncol. 2021 May;17(15):1855-1863. doi: 10.2217/fon-2020-0877. Epub 2021 Jan 21.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eisai Medical Information study director
Eisai Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing lenvatinib in people with Solid Tumor, run by Eisai Co., Ltd. at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03009292, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2021.