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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03173560




Registration number
NCT03173560
Ethics application status
Date submitted
22/05/2017
Date registered
2/06/2017
Date last updated
2/06/2020

Titles & IDs
Public title
Trial to Assess Safety and Efficacy of Lenvatinib in Combination With Everolimus in Participants With Renal Cell Carcinoma
Scientific title
A Randomized, Open-Label (Formerly Double-Blind), Phase 2 Trial to Assess Safety and Efficacy of Lenvatinib at Two Different Starting Doses (18 mg vs. 14 mg QD) in Combination With Everolimus (5 mg QD) in Renal Cell Carcinoma Following One Prior VEGF-Targeted Treatment
Secondary ID [1] 0 0
2016-002778-11
Secondary ID [2] 0 0
E7080-G000-218
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Renal Cell Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Non melanoma skin cancer
Cancer 0 0 0 0
Kidney

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - lenvatinib
Treatment: Drugs - everolimus

Experimental: Lenvatinib 18 mg plus everolimus 5 mg - Participants will receive oral lenvatinib 18 milligrams (mg) once daily (QD) plus oral everolimus 5 mg QD as the starting dose in Cycle 1.

Experimental: Lenvatinib 14 mg plus everolimus 5 mg - Participants will receive oral lenvatinib 14 mg QD plus oral everolimus 5 mg QD as the starting dose for Cycle 1. If there are no intolerable Grade 2 or any = Grade 3 treatment-emergent adverse events (TEAEs) that require dose reduction in the first 28-day cycle (ie, the first 4 weeks of treatment), the lenvatinib dose will be escalated to 18 mg QD (plus everolimus 5 mg) beginning in Cycle 2.


Treatment: Drugs: lenvatinib
lenvatinib capsules.

Treatment: Drugs: everolimus
everolimus tablets.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Objective response rate (ORR) at Week 24 (ORR24W) as assessed by the investigator according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 - ORR24W is defined as the proportion of participants with a best overall response (BOR) of complete response (CR) or partial response (PR) at the Week 24 (after randomization) time point or earlier. To be considered a BOR, all responses must be confirmed no less than 4 weeks after the initial assessment of response.
Timepoint [1] 0 0
Week 24
Primary outcome [2] 0 0
Percentage of participants with intolerable Grade 2 or any = Grade 3 treatment-emergent adverse events (TEAEs) within 24 weeks after randomization (as of the Week-24 time point) - Adverse events (AEs) will be graded using Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. The CTCAE is a list of AE terms commonly encountered in oncology. Each AE term is defined and accompanied by a grading scale that indicates the severity of the AE. Intolerable toxicities will be judged as such by the participant and/or physician to be intolerable.
Timepoint [2] 0 0
Week 24
Secondary outcome [1] 0 0
Progression-free survival (PFS) - PFS is defined as the time from the date of randomization to the date of the first documentation of disease progression or date of death, whichever occurs first. For target lesions, progressive disease is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). For non-target lesions, progressive disease is defined as the unequivocal progression of existing non-target lesions. The appearance of one or more new lesions is also considered progression.
Timepoint [1] 0 0
from the date of randomization to the date of the first documentation of disease progression or date of death, whichever occurs first (up to approximately 4 years)
Secondary outcome [2] 0 0
ORR as assessed by the investigator according to RECIST 1.1 at the end of treatment - ORR is defined as the proportion of participants with a best overall response (BOR) of CR or PR at the end of treatment. To be considered a BOR, all responses must be confirmed no less than 4 weeks after the initial assessment of response.
Timepoint [2] 0 0
up to approximately 4 years
Secondary outcome [3] 0 0
Percentage of participants with any treatment-emergent adverse event (TEAE) and percentage of participants with any serious TEAE - An AE is any untoward medical occurrence in a patient or clinical investigation participant administered an investigational product. An AE does not necessarily have a causal relationship with the medicinal product. A serious TEAE is any untoward medical occurrence that at any dose: results in death; is life threatening (ie, the participant was at immediate risk of death from the AE as it occurred; this does not include an event that, had it occurred in a more severe form or was allowed to continue, might have caused death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug).
Timepoint [3] 0 0
up to approximately 4 years
Secondary outcome [4] 0 0
Percentage of participants who discontinue treatment due to toxicity - The percentage of participants who discontinue treatment due to toxicity is defined as the percentage of participants who discontinue study treatment due to TEAEs.
Timepoint [4] 0 0
up to approximately 4 years
Secondary outcome [5] 0 0
Time to treatment failure due to toxicity - Time to treatment failure is defined as the time from the date of randomization to the date that a participant discontinues study treatment due to TEAEs.
Timepoint [5] 0 0
from the date of randomization to the date of discontinuation of study treatment due to a TEAE (up to approximately 4 years)
Secondary outcome [6] 0 0
Apparent clearance - The empirical Bayesian estimate of lenvatinib and everolimus apparent clearance for each participant will be obtained from the final pharmacokinetic (PK) model and the observed plasma concentration data.
Timepoint [6] 0 0
Cycle 1, Day 1 (C1D1) (each cycle is 28 days): 0.5 to 4 hours postdose, 6 to 10 hours postdose; C1D15: predose on Day 15, 0.5 to 4 hours postdose, 6 to 10 hours postdose; C2D1: predose on Day 1, 2 to 12 hours postdose
Secondary outcome [7] 0 0
Area under the plasma drug concentration-time curve (AUC) - Individual lenvatinib and everolimus AUCs will be derived from the clearance and dose history data.
Timepoint [7] 0 0
C1D1 (each cycle is 28 days): 0.5 to 4 hours postdose, 6 to 10 hours postdose; C1D15: predose on Day 15, 0.5 to 4 hours postdose, 6 to 10 hours postdose; C2D1: predose on Day 1, 2 to 12 hours postdose
Secondary outcome [8] 0 0
Population PK-derived AUC - Lenvatinib and everolimus exposure parameters derived from the population PK analysis will be related to biomarker, safety, and efficacy data using a model-based approach.
Timepoint [8] 0 0
C1D1 (each cycle is 28 days): 0.5 to 4 hours postdose, 6 to 10 hours postdose; C1D15: predose on Day 15, 0.5 to 4 hours postdose, 6 to 10 hours postdose; C2D1: predose on Day 1, 2 to 12 hours postdose
Secondary outcome [9] 0 0
Overall survival (OS) - OS will be measured from the date of randomization until the date of death from any cause. In the absence of confirmation of death, participants will be censored either at the date that the participant was last known to be alive or the date of data cutoff, whichever comes earlier.
Timepoint [9] 0 0
from the date of randomization until the date of death from any cause (up to approximately 4 years)
Secondary outcome [10] 0 0
Health-Related Quality of Life (HRQoL) assessed by Functional Assessment of Cancer Therapy Kidney Syndrome Index-Disease-Related Symptoms (FKSI-DRS) scores - The FKSI-DRS consists of 9 items that experts and participants have indicated are important targets for the treatment of advanced kidney cancer, and that clinical experts have indicated are primarily disease related, as opposed to treatment related. Symptoms assessed on the FKSI-DRS include pain, fatigue, shortness of breath, fevers, weight loss, coughing, and blood in urine. The total score can range from 0 (worst) to 36 (best).
Timepoint [10] 0 0
Baseline (prior to first dose of study drug), on Day 1 of each subsequent cycle, and at the Off-Treatment Visit (up to a maximum of 4 years)
Secondary outcome [11] 0 0
HRQoL assessed by European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 scores - The QLQ-C30 measure comprises 9 multiple-item scales and 6 single items. Multiple-item scales of QLQ-C30 consist of 6 functional scales (physical, role, emotional, cognitive, social and global QoL) and 3 symptom scales (fatigue, nausea and vomiting, pain). Six single-item scales of QLQ-C30 involve dyspnea, sleep disturbance, appetite loss, constipation, diarrhea and financial impact. All of the derived scales range in scores from 0 to 100. For the overall Health Related Quality of Life (HRQoL) and functioning scales, a higher score is correlated with better HRQoL, whereas a higher score represents worse HRQoL for symptom scales.
Timepoint [11] 0 0
Baseline (prior to first dose of study drug), on Day 1 of each subsequent cycle, and at the Off-Treatment Visit (up to a maximum of 4 years)
Secondary outcome [12] 0 0
HRQoL assessed by European Quality of Life (EuroQol) Five-Dimensional, 3-Level (EQ-5D-3L) questionnaire scores - The EQ-5D-3L generic QoL questionnaire is comprised of 5 dimensions: mobility, self-care, usual activities, pain or discomfort, and anxiety or depression. Each dimension has 3 levels:
(1) no problem, (2) some problem, or (3) extreme problem. Thus, the final scoring consists of 243 possible combinations or health states. The utility value for each state is assigned on the basis of a set of preference weights (tariffs) elicited from the general population.
Timepoint [12] 0 0
Baseline (prior to first dose of study drug), on Day 1 of each subsequent cycle, and at the Off-Treatment Visit (up to a maximum of 4 years)
Secondary outcome [13] 0 0
PFS after next line of treatment (PFS2) - PFS is defined as the time from the date of randomization to the date of the first documentation of disease progression or date of death, whichever occurs first. Progressive disease is defined as the unequivocal progression of existing non-target lesions. The appearance of one or more new lesions is also considered progression.
Timepoint [13] 0 0
the time from randomization to the date of disease progression after next line of therapy or death from any cause, whichever occurs first (up to approximately 4 years)

Eligibility
Key inclusion criteria
- Histological or cytological confirmation of predominant clear cell renal cell
carcinoma (RCC) (original tissue diagnosis of RCC is acceptable)

- Documented evidence of advanced RCC

- One prior disease progression episode on or after vascular endothelial growth factor
(VEGF)-targeted treatment (for example, but not limited to, sunitinib, sorafenib,
pazopanib, cabozantinib, bevacizumab, axitinib, vatalanib, AV951/tivozanib)
administered for the treatment of RCC. Prior programmed cell death protein 1
(PD-1)/programmed death-ligand 1 (PD-L1) treatment in addition to 1 prior
VEGF-targeted treatment is allowed.

- At least 1 measurable target lesion according to Response Evaluation Criteria in Solid
Tumors (RECIST 1.1) meeting the following criteria:

- Lymph node (LN) lesion that measures at least 1 dimension as =1.5 centimeter (cm)
in the short axis;

- Non-nodal lesion that measures =1.0 cm in the longest diameter;

- The lesion is suitable for repeat measurement using computerized
tomography/magnetic resonance imaging (CT/MRI). Lesions that have had external
beam radiotherapy (EBRT) or locoregional therapy must show radiographic evidence
of disease progression based on RECIST 1.1 to be deemed a target lesion.

- Male or female participants age =18 years (or any age =18 years if that age is
considered to be an adult per the local jurisdiction) at the time of informed consent

- Karnofsky Performance Status (KPS) of =70

- Adequately controlled blood pressure (BP) with or without antihypertensive
medications, defined as BP =150/90 millimeters of mercury (mmHg) at Screening and no
change in antihypertensive medications within 1 week before Cycle 1/Day 1

- Adequate renal function defined as calculated creatinine clearance =30 milliliters per
minute (mL/min) per the Cockcroft and Gault formula

- Adequate bone marrow function defined by:

- Absolute neutrophil count (ANC) =1500/millimeters cubed (mm^3) (=1.5 ×
10^9/Liters [L]);

- Platelets =100,000/mm^3 (=100 × 10^9/L);

- Hemoglobin =9 grams per deciliter (g/dL)

- Adequate blood coagulation function defined by International Normalized Ratio (INR)
=1.5 (except for participants on warfarin therapy where INR must be =3.0 prior to
randomization)

- Adequate liver function defined by:

- Total bilirubin =1.5 times the upper limit of normal (ULN) except for
unconjugated hyperbilirubinemia of Gilbert's syndrome;

- Alkaline phosphatase (ALP), alanine aminotransferase (ALT), and aspartate
aminotransferase (AST) =3× the ULN (in the case of liver metastases =5× the ULN).
Participants with bone metastases with ALP values greater than 3 times can be
included.

- Participant must voluntarily agree to provide written informed consent

- Participant must be willing and able to comply with all aspects of the protocol
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- More than 1 prior VEGF-targeted treatment for advanced RCC

- Participants with Central Nervous System (CNS) metastases are not eligible, unless
they have completed local therapy for at least 4 weeks and have discontinued the use
of corticosteroids for this indication or are on a tapering regimen of corticosteroids
(defined as =10 milligrams [mg] prednisolone equivalent) before starting treatment in
this study. Any signs (eg, radiologic) or symptoms of brain metastases must be stable
for at least 4 weeks before starting study treatment.

- Active malignancy (except for RCC or definitively treated basal or squamous cell
carcinoma of the skin, or carcinoma in-situ of the cervix or bladder) within the past
24 months

- Any anti-cancer treatment (except for radiation therapy) within 21 days, or any
investigational agent within 30 days prior to the first dose of study drug;
participants should have recovered from any toxicity related to previous anti-cancer
treatment to Common Toxicity Criteria (CTC) grade 0 or 1.

- Prior radiation therapy within 21 days prior to the start of study treatment with the
exception of palliative radiotherapy to bone lesions, which is allowed if completed 2
weeks prior to study treatment start

- Known intolerance to study drug (or any of the excipients) and/or known
hypersensitivity to rapamycins (eg, sirolimus, everolimus, temsirolimus) or any of the
excipients

- Participants with proteinuria >1+ on urinalysis will undergo 24-hour urine collection
for quantitative assessment of proteinuria. Participants with urine protein =1 g/24
hour will be ineligible.

- Fasting total cholesterol ?300 mg/dL (or ?7.75 millimoles [mmol]/L) and/or fasting
triglycerides level ?2.5 × the ULN. Note: these participants can be included after
initiation or adjustment of lipid-lowering medication.

- Uncontrolled diabetes as defined by fasting glucose >1.5 times the ULN. Note: these
participants can be included after initiation or adjustment of glucose-lowering
medication.

- Prolongation of QT corrected (QTc) interval to >480 milliseconds (ms)

- Participants who have not recovered adequately from any toxicity and/or complications
from major surgery prior to starting therapy

- Gastrointestinal malabsorption, gastrointestinal anastomosis, or any other condition
that might affect the absorption of lenvatinib or everolimus

- Bleeding or thrombotic disorders or participants at risk for severe hemorrhage. The
degree of tumor invasion/infiltration of major blood vessels (eg, carotid artery)
should be considered because of the potential risk of severe hemorrhage associated
with tumor shrinkage/necrosis following lenvatinib therapy.

- Clinically significant hemoptysis or tumor bleeding within 2 weeks prior to the first
dose of study drug

- Significant cardiovascular impairment within 6 months prior to the first dose of study
drug; history of congestive heart failure greater than New York Heart Association
(NYHA) Class II, unstable angina, myocardial infarction or stroke, or cardiac
arrhythmia associated with significant cardiovascular impairment or left ventricular
ejection fraction (LVEF) below the institutional normal range as determined by
screening multigated acquisition (MUGA) scan or echocardiogram.

- Active infection (any infection requiring systemic treatment)

- Any medical or other condition that in the opinion of the investigator(s) would
preclude the participant's participation in a clinical study

- Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a
positive beta-human chorionic gonadotropin [ß-hCG] (or human chorionic gonadotropin
[hCG]) test with a minimum sensitivity of 25 International Units per Liter [IU/L] or
equivalent units of ß-hCG [or hCG]). A separate baseline assessment is required if a
negative screening pregnancy test was obtained more than 72 hours before the first
dose of study drug.

- Females of childbearing potential who (Note: all females will be considered to be of
childbearing potential unless they are postmenopausal [amenorrheic for at least 12
consecutive months, in the appropriate age group, and without other known or suspected
cause] or have been sterilized surgically [ie, bilateral tubal ligation, total
hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before
dosing].):

- do not agree to use a highly effective method of contraception for the entire
study period and for up to 8 weeks after study drug discontinuation, ie:

- total abstinence (if it is their preferred and usual lifestyle)

- an intrauterine device (IUD) or hormone releasing system (IUS)

- a contraceptive implant

- an oral contraceptive (with additional barrier method) (Note: Participants
must be on a stable dose of the same oral hormonal contraceptive product for
at least 4 weeks before dosing with study drug and for the duration of the
study.) OR

- do not have a vasectomized partner with confirmed azoospermia

For sites outside of the European Union, it is permissible that if a highly effective
method of contraception is not appropriate or acceptable to the participant, then the
participant must agree to use a medically acceptable method of contraception, ie double
barrier methods of contraception, such as condom plus diaphragm or cervical/vault cap with
spermicide.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
Macquarie University - Macquarie Park
Recruitment hospital [2] 0 0
Northern Cancer Institute, Saint Leonards - Saint Leonards
Recruitment hospital [3] 0 0
Adelaide Cancer Center - Kurralta Park
Recruitment hospital [4] 0 0
Sunshine Hospital - Saint Albans
Recruitment hospital [5] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 0 0
- Macquarie Park
Recruitment postcode(s) [2] 0 0
- Saint Leonards
Recruitment postcode(s) [3] 0 0
- Kurralta Park
Recruitment postcode(s) [4] 0 0
- Saint Albans
Recruitment postcode(s) [5] 0 0
- Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Hawaii
Country [4] 0 0
United States of America
State/province [4] 0 0
Oklahoma
Country [5] 0 0
United States of America
State/province [5] 0 0
Pennsylvania
Country [6] 0 0
United States of America
State/province [6] 0 0
Tennessee
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
Canada
State/province [8] 0 0
Alberta
Country [9] 0 0
Canada
State/province [9] 0 0
British Columbia
Country [10] 0 0
Canada
State/province [10] 0 0
Ontario
Country [11] 0 0
Canada
State/province [11] 0 0
Quebec
Country [12] 0 0
Czechia
State/province [12] 0 0
Brno
Country [13] 0 0
Czechia
State/province [13] 0 0
Olomouc
Country [14] 0 0
Czechia
State/province [14] 0 0
Prague
Country [15] 0 0
Finland
State/province [15] 0 0
Helsinki
Country [16] 0 0
Finland
State/province [16] 0 0
Tampere
Country [17] 0 0
Finland
State/province [17] 0 0
Turku
Country [18] 0 0
Finland
State/province [18] 0 0
Vaasa
Country [19] 0 0
Greece
State/province [19] 0 0
Athens
Country [20] 0 0
Greece
State/province [20] 0 0
Patras
Country [21] 0 0
Greece
State/province [21] 0 0
Pylaia
Country [22] 0 0
Greece
State/province [22] 0 0
Thessaloniki
Country [23] 0 0
Italy
State/province [23] 0 0
Lombardia
Country [24] 0 0
Italy
State/province [24] 0 0
Arezzo
Country [25] 0 0
Italy
State/province [25] 0 0
Napoli
Country [26] 0 0
Italy
State/province [26] 0 0
Roma
Country [27] 0 0
Korea, Republic of
State/province [27] 0 0
Gyeonggido
Country [28] 0 0
Korea, Republic of
State/province [28] 0 0
Chonam
Country [29] 0 0
Korea, Republic of
State/province [29] 0 0
Seoul
Country [30] 0 0
Netherlands
State/province [30] 0 0
Den Haag
Country [31] 0 0
Netherlands
State/province [31] 0 0
Leiden
Country [32] 0 0
Poland
State/province [32] 0 0
Brzozow
Country [33] 0 0
Poland
State/province [33] 0 0
Gdansk
Country [34] 0 0
Poland
State/province [34] 0 0
Krakow
Country [35] 0 0
Poland
State/province [35] 0 0
Lublin
Country [36] 0 0
Poland
State/province [36] 0 0
Opole
Country [37] 0 0
Poland
State/province [37] 0 0
Rzeszow
Country [38] 0 0
Poland
State/province [38] 0 0
Warszawa
Country [39] 0 0
Portugal
State/province [39] 0 0
Coimbra
Country [40] 0 0
Portugal
State/province [40] 0 0
Lisboa
Country [41] 0 0
Portugal
State/province [41] 0 0
Lisbon
Country [42] 0 0
Portugal
State/province [42] 0 0
Porto
Country [43] 0 0
Romania
State/province [43] 0 0
Cluj-Napoca
Country [44] 0 0
Romania
State/province [44] 0 0
Craiova
Country [45] 0 0
Romania
State/province [45] 0 0
Timisoara
Country [46] 0 0
Russian Federation
State/province [46] 0 0
Barnaul
Country [47] 0 0
Russian Federation
State/province [47] 0 0
Chelyabinsk
Country [48] 0 0
Russian Federation
State/province [48] 0 0
Moscow
Country [49] 0 0
Russian Federation
State/province [49] 0 0
Obninsk
Country [50] 0 0
Russian Federation
State/province [50] 0 0
Omsk
Country [51] 0 0
Russian Federation
State/province [51] 0 0
Yaroslavl
Country [52] 0 0
Spain
State/province [52] 0 0
A Coruna
Country [53] 0 0
Spain
State/province [53] 0 0
Badalona
Country [54] 0 0
Spain
State/province [54] 0 0
Barcelona
Country [55] 0 0
Spain
State/province [55] 0 0
Cordoba
Country [56] 0 0
Spain
State/province [56] 0 0
Hospitalet de Llobregat
Country [57] 0 0
Spain
State/province [57] 0 0
Madrid
Country [58] 0 0
Spain
State/province [58] 0 0
Palma de Mallorca
Country [59] 0 0
Spain
State/province [59] 0 0
Pamplona
Country [60] 0 0
Spain
State/province [60] 0 0
Valencia
Country [61] 0 0
Taiwan
State/province [61] 0 0
Taichung
Country [62] 0 0
Taiwan
State/province [62] 0 0
Taipei
Country [63] 0 0
United Kingdom
State/province [63] 0 0
Glasgow
Country [64] 0 0
United Kingdom
State/province [64] 0 0
Manchester
Country [65] 0 0
United Kingdom
State/province [65] 0 0
Northwood
Country [66] 0 0
United Kingdom
State/province [66] 0 0
Swansea

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Eisai Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Study E7080-G000-218 is a Randomized, open-label (formerly Double-blind), Phase 2 Trial
conducted to assess whether a starting dose of lenvatinib 14 milligrams (mg) in combination
with everolimus 5 mg once daily (QD) will provide comparable efficacy (based on objective
response rate [ORR] at 24 weeks [ORR24W]) with an improved safety profile compared to
lenvatinib 18 mg in combination with everolimus 5 mg (based on treatment-emergent intolerable
Grade 2, or any = Grade 3 adverse events (AEs) in the first 24 weeks after randomization).
Trial website
https://clinicaltrials.gov/show/NCT03173560
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications