Phase
Condition
Neoplasms
Liver Cancer
Endometrial Cancer
Treatment
Lenvatinib
Paclitaxel
Doxorubicin
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
HCC part only: Participants with confirmed diagnosis of unresectable HCC with any of the followingcriteria:
Histologically or cytologically confirmed diagnosis of HCC, excludingfibrolamellar, sarcomatoid or mixed cholangio-HCC tumors
Clinically confirmed diagnosis of HCC according to American Association for theStudy of Liver Diseases (AASLD) criteria, including cirrhosis of any etiologyand/or chronic hepatitis B or C infection ST part only (except for HCC): Participants with histologically or cytologically confirmed diagnosis of solid tumorfor which no alternative standard therapy or no effective therapy exists
Life expectancy of >=12 weeks
Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1
All AEs due to previous anti-cancer therapy have either returned to Grade 0 to 1except for alopecia or up to Grade 2 peripheral neuropathy (renal/bone marrow/liverfunction should meet the inclusion criteria)
Adequate washout period before study drug administration:
Chemotherapy and radiotherapy: 3 weeks or 5 times the half-life, whichever isshorter
Any antitumor therapy with antibody: 4 weeks or more
Any investigational drug or device: 4 weeks or more
Blood/platelet transfusion or granulocyte colony-stimulating factor (G-CSF): 2weeks or more Note: Participants must have recovered from all radiation-relatedtoxicities, not require corticosteroids, and not had radiation pneumonitis
Adequate controlled blood pressure (BP), renal function, bone marrow function, liverfunction, and serum mineral level
At least one measurable lesion based on mRECIST (for HCC Subparts in Dose EscalationPart) or on RECIST 1.1 (for Other ST Subparts in Dose Escalation Part and allsubparts in Expansion and Dose Optimization Parts) meeting following criteria
At least 1 lesion of >=1.0 centimeter (cm) in the longest diameter for anon-lymph node or >=1.5 cm in the short-axis diameter for a lymph node that isserially measurable according to RECIST 1.1 using computerized tomography (CT)/magnetic resonance imaging (MRI)
Lesions that have had external beam radiotherapy or loco-regional therapiessuch as radiofrequency ablation, or transarterial chemoembolisation (TACE)/transarterial embolization (TAE) must show evidence of progressive diseasebased on RECIST 1.1 to be deemed a target lesion
For HCC participants only: Child-Pugh score A. Note: If Child-Pugh score 7 or morewas observed during Screening or Baseline, the participant is ineligible andre-assessment of the Child-Pugh score is not permitted
For HCC participants only: Participants categorized to stage B (not amenable tolocoregional therapy or refractory to locoregional therapy, and not amenable to acurative treatment), or stage C based on Barcelona Clinic Liver Cancer (BCLC)staging system
For HCC Subpart in Expansion Part only: prior systemic therapy for locally advancedor metastatic disease is as defined below a. Participants who have received only one prior line of immuno oncology (IO) basedregimen and have progressed on or after prior treatment with IO based regimen, or IOineligible participants who have received no prior systemic therapy. Participantswho previously received lenvatinib treatment are ineligible
For CRC Subpart in Expansion Part only: participants must have received at least 2prior regimens (not exceeding 4 prior regimens) or could not tolerate standardtreatment and must have received the following prior therapies in the metastaticsetting if approved and locally available (progressed on at least 1 prior regimen inthe metastatic setting or could not tolerate standard treatment): Note: Adjuvant chemotherapy counts as prior systemic treatment if there isdocumented disease progression within 6 months of treatment completion Note: If aparticipant is determined to be intolerant to prior standard treatment, theparticipant must have received at least of 2 cycles of that therapy Note:Participants who have received oral tyrosine kinase inhibitor (example, regorafenib)are ineligible
Fluoropyrimidine, irinotecan and oxaliplatin with or without an anti-Vascularendothelial growth factor (VEGF) monoclonal antibody (mAb) (example,bevacizumab) Note: Capecitabine is acceptable as equivalent to fluoropyrimidinein prior treatment Note: Participants who have previously receivedfluoropyrimidine, oxaliplatin, and irinotecan as part of the same and onlychemotherapy regimen, example, FOLFOXIRI or FOLFIRINOX, may be eligible afterdiscussion with the Sponsor
Chemotherapy with anti- epidermal growth factor receptor (EGFR) mAb (cetuximabor panitumumab) for participants with rat sarcoma virus (RAS) (Kirsten ratsarcoma viral oncogene homolog [KRAS)/ NRAS]) wild type (WT) CRC Note: RAS (KRAS/NRAS) WT participants with right or left CRC lesions who may have notbeen treated with anti-EGFR mAb based on local guidelines are eligible
BRAF inhibitor (in combination with cetuximab ± binimetinib) for BRAF V600Emutated tumors
Immune checkpoint inhibitor for participants with microsatelliteinstability-high (MSI-H) CRC
For EC Subpart in Expansion Part only: Participants must have EC that has progressedafter prior platinum-based chemotherapy and an anti-programmed cell death (ligand) 1 (PD-[L])1)-directed therapy for EC (participants ineligible for IO therapy who haveprogressed after prior platinum-based chemotherapy are eligible). Up to 3 priorsystemic therapies, of which up to 2 for metastatic or locally advanced disease, arepermitted Note: There is no restriction regarding prior hormonal therapies For DoseOptimization Part only: Participants must have EC that has progressed after priorplatinum-based chemotherapy and an anti-PD-(L)1-directed therapy for EC. Up to 3lines of prior therapy, regardless of setting, are allowed. Note: Prior hormonaltherapy and radiation are allowed and do not count as prior lines of therapy.
Exclusion
Exclusion Criteria:
- Any of cardiac conditions as follows:
Heart failure New York Heart Association (NYHA) Class II or above
Prolongation of QT interval with Fridericias correction (QTcF) to greater than (>) 480 millisecond (msec)
Left ventricular ejection fraction (LVEF) less than (<) 50 percent (%)
Major surgery within 21 days or minor surgery (that is, simple excision) within 7days prior to starting study drug. Participant must have recovered from the surgeryrelated toxicities to less than Grade 2 Note: Adequate wound healing after majorsurgery must be assessed clinically, independent of time elapsed for eligibility
Known to be human immunodeficiency virus (HIV) positive Note: the sponsor hasevaluated whether to include participant with HIV. Given that this is the firstcombination study of E7386 with lenvatinib and that the main mechanism of action ofE7386 is immunomodulation of the tumor microenvironment along with the fact thatseveral anti-retroviral therapies have drug-drug interaction with cytochrome P450 3A (CYP3A) substrates, the sponsor has decided not to include these participants at thecurrent time. However, further considerations will be made moving forward based onnew emerging data Note: HIV testing is required at screening only when mandated bylocal health authority
Participants with proteinuria on urine dipstick testing will undergo 24-hour urinecollection for quantitative assessment of proteinuria. Participants with urineprotein >=1 gram per 24 hour will be ineligible
Active infection requiring systemic treatment (Except for Hepatitis B and/or C [HBV/HCV] infection in HCC participants) In case of HBsAg (+) participants in HCC participants:
Antiviral therapy for HBV is not ongoing
HBV viral load is 2000 international unit per milliliter (IU/mL) or more at theScreening Period although antiviral therapy for HBV is ongoing
Has dual active HBV infection (HBsAg (+) and/or detectable HBV deoxyribonucleicacid [DNA]) and HCV infection (anti-HCV Ab (+) and detectable HCV ribonucleicacid [RNA]) at study entry
Diagnosed with meningeal carcinomatosis
Participants with central nervous system metastases are only eligible if they havebeen previously treated and are radiologically stable, (that is, without evidence ofprogression for at least 4 weeks prior to first dose of study treatment by repeatimaging), clinically stable, and without requirement of steroid treatment for atleast 14 days prior to first dose of study treatment
Pulmonary lymphangitic involvement that results in pulmonary dysfunction requiringactive treatment, including the use of oxygen
Any of bone disease/conditions as follows:
T-score of < minus (-) 3.0 at the left or right total hip, left or rightfemoral neck or lumbar spine (L1-L4) as determined by dual energy x-rayabsorptiometry (DXA) scan. Participants with T-score <-2.5 to -3.0 can only beincluded if treatment with a bisphosphonate (example, zoledronic acid) ordenosumab has been started at least 14 days and no more than 6 months prior tothe first dose of study drug
Metabolic bone disease, such as hyperparathyroidism, Paget's disease orosteomalacia
Symptomatic hypercalcemia requiring bisphosphonate therapy
History of any fracture within 6 months prior to starting study drug
Bone metastasis requiring orthopedic intervention
Bone metastasis not being treated by bisphosphonate or denosumab. Participantsmay be included if treatment with bisphosphonate or denosumab has been startedat least 14 days prior to the first dose of study drug. Participants withprevious solitary bone lesions controlled with radiotherapy are eligible
History of symptomatic vertebral fragility fracture or any fragility fractureof the hip, pelvis, wrist or other location (defined as any fracture without ahistory of trauma or because of a fall from standing height or less)
Moderate (25% to 40% decrease in the height of any vertebrae) or severe (>40%decrease in the height of any vertebrae) morphometric vertebral fracture atbaseline
History of malignancy (except for original disease, or definitively treated melanomain-situ, basal or squamous cell carcinoma of the skin, carcinoma in-situ [example,bladder or cervix]) within the past 24 months prior to the first dose of study drug
For HCC Subpart in Dose Escalation Part only: Participants who experienceddiscontinuation of lenvatinib, 2 or more dose reductions of lenvatinib required frominitial dose level of this study due to its toxicity, or participants whoexperienced single dose reduction or consecutive >=8 days dose interruption oflenvatinib within 60 days from the first dose, due to its toxicity. HCC Subpart inExpansion Part only: Participants who previously received lenvatinib treatment areineligible. EC Subpart in Expansion Part only: Participants previously treated with lenvatinibwho experienced discontinuation of lenvatinib due to toxicity, or dose reduction toless than 10 mg of lenvatinib due to toxicity within 60 days from the first dose. EC Dose Optimization Part only: Participants who previously received lenvatinibtreatment are ineligible.
Bleeding or thrombotic disorders or use of anticoagulants requiring therapeuticInternational Normalized Ratio (INR) monitoring for HCC participants only (example,warfarin or similar agents). Treatment with low molecular weight heparin and factorX inhibitors is permitted. Treatment with antiplatelet agents is prohibited for HCCparticipants in Dose Escalation Part only
Gastrointestinal bleeding event or active hemoptysis (bright red blood of at least 0.5 teaspoon) within 3 weeks prior to the first dose of study drug
For HCC participants only: History of hepatic encephalopathy within 6 months priorto starting study drug
For EC Subpart in Expansion and Dose Optimization Parts only: carcinosarcoma (malignant mixed Mullerian tumor), endometrial leiomyosarcoma, and endometrialstromal sarcomas
Has preexisting >=Grade 3 gastrointestinal or non-gastrointestinal fistula
Evidence of current Coronavirus disease 2019 (COVID-19) infection or ongoingunrecovered active sequelae of COVID-19 infection
Males who have not had a successful vasectomy (confirmed azoospermia) if theirfemale partners meet the exclusion criteria above (that is, the female partners areof childbearing potential and are not willing to use a highly effectivecontraceptive method throughout the study period and after study drugdiscontinuation). No sperm donation is allowed during the study period and afterstudy drug discontinuation
Has a known psychiatric or substance abuse disorder that would interfere with theparticipant ability to cooperate with the requirements of the study
Evidence of clinically significant disease (example, cardiac, respiratory,gastrointestinal, renal disease) that in the opinion of the investigator couldaffect the participant safety or interfere with the study assessments
Scheduled for major surgery during the study
Study Design
Connect with a study center
Sunnybrook Hospital
Toronto, Ontario
CanadaSite Not Available
CHUM, Unit for Innovative Therapies
Montreal, Quebec
CanadaSite Not Available
McGill University Health Centre
Montreal, Quebec
CanadaSite Not Available
Beijing Cancer Hospital
Beijing,
ChinaSite Not Available
Peking Union Medical College Hospital
Beijing,
ChinaSite Not Available
Bethune Hospital of Jilin University
Changchun,
ChinaActive - Recruiting
Fujian Provincial Cancer Hospital
Fuzhou,
ChinaActive - Recruiting
Sun Yan-sen University Cancer Center
Guangzhou,
ChinaSite Not Available
Sun Yat-Sen Memrial Hospital, Sun Yat-Sen University
Guangzhou,
ChinaSite Not Available
Cancer Hospital of Shandong First Medical University
Jinan,
ChinaSite Not Available
Yunnan Cancer Hospital
Kunming,
ChinaActive - Recruiting
Fudan University Cancer Center
Shanghai,
ChinaActive - Recruiting
The Tenth People's Hospital; Shanghai Tongji University
Shanghai,
ChinaActive - Recruiting
Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center
Shenzhen,
ChinaSite Not Available
Tianjin Cancer Hospital
Tianjin,
ChinaSite Not Available
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou,
ChinaSite Not Available
Rigshospatalet
Copenhagen,
DenmarkSite Not Available
Odense University Hospital
Odense,
DenmarkSite Not Available
CHU Amiens-Picardie (Hopital Sud)
Amiens, 80000
FranceCompleted
CHU Bordeaux
Bordeaux, 33075
FranceSite Not Available
CHU Cavale Blanche
Brest, 29200
FranceActive - Recruiting
Centre François Baclesse
Caen, 14000 Caen
FranceSite Not Available
Centre Jean Perrin
Clermont-Ferrand, 63000 Clermont-Ferrand
FranceSite Not Available
Hôpital Beaujon
Clichy, 92110
FranceSite Not Available
Centre Georges-François Leclerc
Dijon, 21000
FranceSite Not Available
Grenoble University Hospital (Centre Hospitalier Universitaire Grenoble Alpes)
La Tronche, 38700
FranceSite Not Available
CHU de LILLE - Hôpital HURIEZ
Lille, 59037
FranceSite Not Available
Centre Léon Bérard
Lyon, 69008 Lyon
FranceSite Not Available
Hepatology, Hopital de la Croix-Rousse - 103 grande rue de la Croix-Rousse
Lyon, 69004
FranceSite Not Available
Institut Paoli-Calmettes
Marseille, 3009 Marseille
FranceSite Not Available
Centre Antoine Lacassagne
Nice, 06100 Nice
FranceSite Not Available
AP-HP Université de Paris, Port Royal
Paris, 75014 Paris
FranceSite Not Available
APHP Hospital Saint-Antoine
Paris, 75012
FranceSite Not Available
Hopital Europeen Georges-Pompidou (HEGP)
Paris, 75015
FranceSite Not Available
Hopital de la Croix Saint-Simon
Paris, 75020
FranceSite Not Available
Institut Curie - Centre de Recherche
Paris, 75005
FranceActive - Recruiting
Centre Hospitalier Universitaire de Bordeaux (CHU Bordeaux)(Hopitaux de Bordeaux) - Groupe hospitalier Sud - Hopital Haut-Levequ
Pessac, 33604
FranceSite Not Available
Centre Hospitalier Universitaire (CHU) de Poitiers
Poitiers, 86000 Poitiers
FranceActive - Recruiting
Insitute de Cancérologie de l'Ouest - Centre René Gauducheau
Saint-Herblain, Saint-Herblain 44800
FranceSite Not Available
ICANs
Strasbourg, 67200 Strasbourg
FranceSite Not Available
Gustave Roussy Institute (IGR)
Villejuif, 94805
FranceActive - Recruiting
Clinica Oncologica AOU (Azienda Ospedaliero Universitaria) delle Marche
Ancona,
ItalySite Not Available
Istituto Clinico Humanitas, Rozzano
Milan,
ItalySite Not Available
Fondazione Policlinico Gemelli IRCCS
Rome,
ItalySite Not Available
Eisai Trial Site #5
Nagoya, Aichi
JapanActive - Recruiting
Eisai Trial Site #11
Toyoake, Aichi
JapanSite Not Available
Eisai Trial Site #2
Kashiwa, Chiba
JapanSite Not Available
Eisai Trial Site #8
Matsuyama, Ehime
JapanCompleted
Eisai Trial Site #7
Kurume, Fukuoka
JapanSite Not Available
Eisai site #13
Akashi, Hyogo
JapanSite Not Available
Eisai Trial Site #10
Kawasaki, Kanagawa
JapanSite Not Available
Eisai Trial Site #12
Kamigyo-ku, Kyoto
JapanCompleted
Eisai Trial Site #3
Osakasayama, Osaka
JapanSite Not Available
Eisai Trial Site #9
Hidaka, Saitama
JapanActive - Recruiting
Eisai Trial Site #1
Chuo-Ku, Tokyo
JapanSite Not Available
Eisai Trial Site #6
Koto-ku, Tokyo
JapanSite Not Available
Eisai Site 15
Minato-ku, Tokyo
JapanSite Not Available
Eisai Trial Site #4
Chiba,
JapanSite Not Available
Eisai site #14
Niigata,
JapanSite Not Available
Eisai Trial Site #1
Seongnamsi Bundang, Gyeonggi-Do
Korea, Republic ofSite Not Available
Eisai Trial Site #2001
Seongnamsi Bundang, Gyeonggi-Do
Korea, Republic ofActive - Recruiting
National Cancer Center
Goyang-si Gyeonggi-do, Ilsandong-gu
Korea, Republic ofSite Not Available
Korea University Guro Hospital
Guro-gu, Seoul
Korea, Republic ofActive - Recruiting
Eisai Trial Site #2005
Jongno-gu, Seoul
Korea, Republic ofActive - Recruiting
Eisai Trial Site #5
Jongno-gu, Seoul
Korea, Republic ofCompleted
Seoul National University Hospital
Jongno-gu, Seoul
Korea, Republic ofSite Not Available
Seoul St. Mary's Hospital
Seocho-Gu, Seoul
Korea, Republic ofSite Not Available
Eisai Trial Site #2
Seodaemun, Seoul
Korea, Republic ofSite Not Available
Eisai Trial Site #2002
Seodaemun, Seoul
Korea, Republic ofActive - Recruiting
Asan Medical Centre
Songpa-Gu, Seoul
Korea, Republic ofSite Not Available
Eisai Trial Site #2004
Songpa-gu, Seoul
Korea, Republic ofActive - Recruiting
Eisai Trial Site #4
Songpa-gu, Seoul
Korea, Republic ofSite Not Available
Eisai Trial Site #2003
Seoul,
Korea, Republic ofActive - Recruiting
Eisai Trial Site #3
Seoul,
Korea, Republic ofSite Not Available
H. Clinico San Carlos
San Carlos, Madrid
SpainSite Not Available
Fundació Privada Institut d'Investigació Oncològica de Vall-Hebron (VHIO)
Barcelona,
SpainSite Not Available
University Hospital A Coruña
Coruna,
SpainSite Not Available
Hospital Universitario de Jaén
Jaen,
SpainSite Not Available
Clínica Universidad de Navarra
Madrid,
SpainSite Not Available
Hospital Universitario 12 de Octubre
Madrid,
SpainSite Not Available
Chang Gung Medical Foundation - Kaohsiung Branch
Kao-Hsiung,
TaiwanSite Not Available
Taichung Veterans General Hospital
Taichung,
TaiwanActive - Recruiting
National Cheng Kung University Hospital
Tainan,
TaiwanCompleted
National Taiwan University Hospital
Taipei,
TaiwanSite Not Available
Taipei Veterans General Hospital
Taipei,
TaiwanCompleted
Chang Gung Medical Foundation - Linkou Branch
Taoyuan,
TaiwanSite Not Available
UAMS
Little Rock, Arkansas 72205
United StatesSite Not Available
University of California San Diego (UCSD) - Moores Cancer Center(All)
La Jolla, California 92037
United StatesActive - Recruiting
Cedars-Sinai Medical Center
Los Angeles, California 90048
United StatesCompleted
Pasadena Liver Center
Pasadena, California 91105
United StatesSite Not Available
California Pacific Medical Center
San Francisco, California 94066
United StatesSite Not Available
UCLA University of California - Los Angeles
Santa Monica, California 90404
United StatesSite Not Available
John Muir Clinical Research
Walnut Creek, California 94598
United StatesSite Not Available
University of Colorado Cancer Center - Anschutz Medical Campus
Aurora, Colorado 80045
United StatesSite Not Available
Uni. Of Miami- Sylvester Cancer Centre
Miami, Florida 33136
United StatesSite Not Available
Florida Cancer Specialists - South
Sarasota, Florida 34236
United StatesSite Not Available
Florida Cancer Specialists - East
West Palm Beach, Florida 33401
United StatesSite Not Available
Women's Cancer Care - Covington, LA
Covington, Louisiana 70433
United StatesSite Not Available
University Of Mississippi Medical Center
Jackson, Mississippi 39216
United StatesSite Not Available
Kansas City Research Institute
Kansas City, Missouri 64131
United StatesCompleted
Montefiore Medical Center (MMC) - Jack D. Weiler Hospital
Bronx, New York 10461
United StatesSite Not Available
Memorial Sloan Kettering Cancer Center
New York, New York 10065
United StatesSite Not Available
Perlmutter Cancer Center- NYU Langone Health
New York, New York 10016
United StatesActive - Recruiting
MetroHealth Medical Center
Cleveland, Ohio 44109
United StatesSite Not Available
ProMedica Flower Hospital
Sylvania, Ohio 43560
United StatesSite Not Available
University of Oklahoma Health Science Center
Oklahoma City, Oklahoma 73104
United StatesSite Not Available
UPMC
Pittsburgh, Pennsylvania 15213
United StatesSite Not Available
Medical University of South Carolina
Charleston, South Carolina 29425
United StatesActive - Recruiting
Sanford Cancer Centre
Sioux Falls, South Dakota 57106
United StatesSite Not Available
Tennessee Oncology
Nashville, Tennessee 37211
United StatesSite Not Available
Vanderbilt University Medical Center (VUMC) - Vanderbilt-Ingram Cancer Center (VICC) - Nashville
Nashville, Tennessee 37232
United StatesSite Not Available
Mary Crowley Cancer Research
Dallas, Texas 75230
United StatesSite Not Available
University of Texas Southwestern Medical
Dallas, Texas 75390
United StatesSite Not Available
MD Anderson Cancer Center
Houston, Texas 77030
United StatesSite Not Available
Fred Hutchinson/University of Washington Cancer Consortium
Seattle, Washington 98109
United StatesSite Not Available
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