Kidney Cancer Clinical Trial

Trial to Assess Safety and Efficacy of Lenvatinib (18 mg vs. 14 mg) in Combination With Everolimus in Participants With Renal Cell Carcinoma

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 greater than or equal to (>=) Grade 3 adverse events (AEs) in the first 24 weeks after randomization).

View Eligibility Criteria

Eligibility Criteria

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 less than or equal to (<=) 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

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 mg prednisolone equivalent) before starting treatment in this study. Any signs (example, 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 (example, sirolimus, everolimus, temsirolimus) or any of the excipients
Participants with proteinuria greater than (>) 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 (example, 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 [β-hCG] (or human chorionic gonadotropin [hCG]) test with a minimum sensitivity of 25 International Units per Liter [IU/L] or equivalent units of β-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 [that is, 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, that is:

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, that is, double barrier methods of contraception, such as condom plus diaphragm or cervical/vault cap with spermicide.

Study is for people with:

Kidney Cancer

Phase:

Phase 2

Estimated Enrollment:

343

Study ID:

NCT03173560

Recruitment Status:

Active, not recruiting

Sponsor:

Eisai Inc.

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There are 18 Locations for this study

See Locations Near You

City of Hope National Medical Center
Duarte California, 91010, United States
Innovative Clinical Research Institute, LLC
Whittier California, 90603, United States
Baptist Health Medical Group Oncology, LLC - US Oncology
Miami Florida, 33143, United States
Optimal Research
Honolulu Hawaii, 96819, United States
Oklahoma Cancer Specialist and Research Institute , LLC
Tulsa Oklahoma, 74146, United States
University of Pittsburgh Medical Center
Pittsburgh Pennsylvania, 15232, United States
University of Tennessee Medical Center
Knoxville Tennessee, 37920, United States
Texas Oncology PA - US Oncology
Fort Worth Texas, 76104, United States
Macquarie University
Macquarie Park New South Wales, , Australia
Northern Cancer Institute, Saint Leonards
Saint Leonards New South Wales, , Australia
Adelaide Cancer Center
Kurralta Park South Australia, , Australia
Sunshine Hospital
Saint Albans Victoria, , Australia
Fiona Stanley Hospital
Murdoch Western Australia, , Australia
Alberta Health Service - Tom Baker Cancer Centre
Calgary Alberta, T2N 4, Canada
British Columbia Cancer Agency
Kelowna British Columbia, V1Y 5, Canada
Juravinski Cancer Centre
Hamilton Ontario, L8V 5, Canada
London Health Sciences Centre
London Ontario, N6A 4, Canada
Ottawa Hospital Cancer Centre
Ottawa Ontario, K1H 8, Canada
Sunnybrook Research Institute- University of Toronto
Toronto Ontario, M4N 3, Canada
Sir Mortimer B Davis Jewish General Hospital
Montreal Quebec, H3T 1, Canada
Masarykuv onkologicky ustav
Brno , , Czechia
Fakultni nemocnice Olomouc
Olomouc , , Czechia
Fakultni nemocnice v Motole
Prague , , Czechia
Nemocnice Na Bulovce
Prague , , Czechia
Helsingin Yliopistollinen Keskussairaala
Helsinki , , Finland
Tampereen yliopistollinen sairaala
Tampere , , Finland
Turun Yliopistollinen Keskussairaala
Turku , , Finland
Vaasan Keskussairaala
Vaasa , , Finland
Alexandra Hospital
Athens , , Greece
Metropolitan hospital
Athens , , Greece
University General Hospital of Patras
Patras , , Greece
Interbalkan Medical Center of Thessaloniki
Pylaia , , Greece
EUROMEDICA General Clinic of Thessaloniki
Thessaloniki , , Greece
Papageorgiou General Hospital of Thessaloniki
Thessaloniki , , Greece
IRCCS Istituto Nazionale dei Tumori
Milano Lombardia, , Italy
Presidio Ospedaliero San Donato
Arezzo , 52100, Italy
AORN A Cardarelli
Napoli , , Italy
Azienda Ospedaliera San Camillo Forlanini
Roma , 00152, Italy
National Cancer Center
Goyang-si Gyeonggido, , Korea, Republic of
Chonnam National University Hwasun Hospital
Chŏnam , , Korea, Republic of
Asan Medical Center
Seoul , , Korea, Republic of
Samsung Medical Center
Seoul , , Korea, Republic of
Severance Hospital - Yonsei University Health System
Seoul , , Korea, Republic of
The Catholic University of Korea, Seoul Saint Mary's Hospital
Seoul , , Korea, Republic of
Hagaziekenhuis
Den Haag , , Netherlands
MC Haaglanden
Den Haag , , Netherlands
Leids Universitair Medisch Centrum
Leiden , , Netherlands
Szpital Specjalistyczny w Brzozowie
Brzozow , , Poland
Copernicus PL Sp. z o.o. Wojewodzkie Centrum Onkologii
Gdansk , , Poland
NZOZ Vesalius
Krakow , , Poland
SP ZOZ Szpital Uniwersytecki w Krakowie
Krakow , , Poland
Centrum Onkologii Ziemi Lubelskiej
Lublin , , Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Opolskie Centrum Onkologii
Opole , , Poland
Mrukmed. Lekarz Beata Madej-Mruk i Partner. Spolka Partnerska
Rzeszow , , Poland
MAGODENT Sp. z o.o. Szpital Elblaska
Warszawa , , Poland
Centro Hospitalar E Universitário de Coimbra EPE
Coimbra , , Portugal
Champalimaud Cancer Center
Lisboa , , Portugal
Centro Hospitalar Lisboa Norte, E.P.E. - Hospital de Santa Maria
Lisbon , , Portugal
Centro Hospitalar do Porto - Hospital de Santo António
Porto , , Portugal
Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe
Porto , , Portugal
Medisprof SRL
Cluj-Napoca , , Romania
Prof Dr I Chiricuta Institute of Oncology
Cluj-Napoca , , Romania
Oncology Center Sfantul Nectarie
Craiova , , Romania
Oncocenter Clinical Oncology
Timisoara , , Romania
Altay Regional Oncology Center
Barnaul , , Russian Federation
Chelyabinsk Regional Clinical Oncology Dispensary
Chelyabinsk , , Russian Federation
Central Clinical Hospital With Polyclinic of President Administration of RF
Moscow , , Russian Federation
Moscow City Oncology Hospital #62
Moscow , , Russian Federation
Moscow Scientific Research Oncology Institute P.A. Herzen
Moscow , , Russian Federation
Federal State Institution Medical Radiology Research Center
Obninsk , , Russian Federation
Clinical Oncology Dispensary
Omsk , , Russian Federation
Regional Clinical Oncology Hospital
Yaroslavl , , Russian Federation
Hospital Universitario A Coruna
A Coruna , , Spain
Hospital Universitario Germans Trias i Pujol
Badalona , , Spain
Hospital Clinic de Barcelona
Barcelona , , Spain
Hospital de la Santa Creu I Sant Pau
Barcelona , , Spain
C.H. Regional Reina Sofia
Cordoba , , Spain
ICO l'Hospitalet - Hospital Duran i Reynals
Hospitalet de Llobregat , , Spain
Hospital Clinico San Carlos
Madrid , 28040, Spain
Hospital Universitario 12 de Octubre
Madrid , , Spain
Hospital Universitario Ramon y Cajal
Madrid , , Spain
MD Anderson Cancer Center Madrid
Madrid , , Spain
Hospital Universitario Son Espases
Palma de Mallorca , , Spain
Clinica Universidad Navarra
Pamplona , , Spain
Fundacion Instituto Valenciano de Oncologia
Valencia , , Spain
China Medical University Hospital
Taichung , , Taiwan
Taichung Veterans General Hospital
Taichung , , Taiwan
National Taiwan University Hospital
Taipei , , Taiwan
Taipei Veterans General Hospital
Taipei , , Taiwan
Beatson West of Scotland Cancer Centre
Glasgow , , United Kingdom
Christie Hospital
Manchester , , United Kingdom
Mount Vernon Hospital
Northwood , , United Kingdom
Singleton Hospital
Swansea , , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Kidney Cancer

Phase:

Phase 2

Estimated Enrollment:

343

Study ID:

NCT03173560

Recruitment Status:

Active, not recruiting

Sponsor:


Eisai Inc.

How clear is this clinincal trial information?

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