A Study of E7386 in Combination With Other Anticancer Drug(s) in Participants With Solid Tumor

NCT ID: NCT04008797

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

301 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-11

Study Completion Date

2027-08-31

Brief Summary

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The primary objective of this study is to assess the safety and tolerability and to determine the recommended Phase 2 dose (RP2D) of E7386 in combination with other anticancer drug(s), and to determine the optimal dose of E7386 in combination with lenvatinib in endometrial carcinoma (EC) (for EC Dose Optimization Part only).

Detailed Description

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The Dose Escalation and Dose Expansion parts of the study have completed enrollment. The Dose Optimization part of the study is enrolling participants with endometrial carcinoma (EC) only.

Conditions

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Endometrial Neoplasms Neoplasms Carcinoma, Hepatocellular Liver Neoplasms Colorectal Neoplasms

Keywords

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Endometrial cancer Solid Tumor Hepatocellular carcinoma Colorectal cancer E7386 Lenvatinib

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

The Dose Optimization part and HCC subpart of Expansion part of the study are randomized. The Dose Escalation part, and CRC/EC subparts of Dose Escalation part are non-randomized.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dose Escalation Part: HCC: E7386 QD Subpart + Lenvatinib

Participants with hepatocellular carcinoma (HCC) will receive E7386, once daily (QD) for 5 or 6 consecutive days followed by a period of time without treatment in Cycle 0 (6 or 7 days). Participants with HCC will receive E7386, QD in combination with lenvatinib 8 milligram (mg) (participants with body weight of less than \[\<\] 60 kilograms \[kg\]) or 12 mg (participants with body weight \>=60 kg), capsules, orally, QD in 28-day treatment cycles until PD, development of unacceptable toxicity, participant request to discontinue, withdrawal of consent, or termination of the study program.

Group Type EXPERIMENTAL

E7386

Intervention Type DRUG

E7386 dosing.

Lenvatinib

Intervention Type DRUG

Lenvatinib dosing.

Dose Escalation Part: HCC: E7386 BID Subpart + Lenvatinib

Participants with HCC will receive E7386, twice daily (BID) for 5 or 6 consecutive days in Cycle 0 (6 or 7 days). Participants with HCC will receive E7386, BID in combination with lenvatinib 8 mg (participants with body weight of \< 60 kg) or 12 mg (participants with body weight \>=60 kg) capsules, orally, QD in 28-day treatment cycles until PD, development of unacceptable toxicity, participant request to discontinue, withdrawal of consent, or termination of the study program.

Group Type EXPERIMENTAL

E7386

Intervention Type DRUG

E7386 dosing.

Lenvatinib

Intervention Type DRUG

Lenvatinib dosing.

Dose Escalation Part: Other ST: E7386 QD Subpart + Lenvatinib

Participants with solid tumor (ST) (except for HCC) will receive E7386, QD for 5 or 6 consecutive days followed by a period of time without treatment in Cycle 0 (6 or 7 days). Participants with ST (except for HCC) will receive E7386, QD in combination with lenvatinib 20 mg, capsules, orally, QD in 28-day treatment cycles until PD, development of unacceptable toxicity, participant request to discontinue, withdrawal of consent, or termination of the study program.

Group Type EXPERIMENTAL

E7386

Intervention Type DRUG

E7386 dosing.

Lenvatinib

Intervention Type DRUG

Lenvatinib dosing.

Dose Escalation Part: Other ST: E7386 BID Subpart + Lenvatinib

Participants with ST (except for HCC) will receive E7386, BID for 5 or 6 consecutive days in Cycle 0 (6 or 7 days). Participants with ST (except for HCC) will receive E7386, BID in combination with lenvatinib 20 mg, capsules, orally, QD in 28-day treatment cycles until PD, development of unacceptable toxicity, participant request to discontinue, withdrawal of consent, or termination of the study program.

Group Type EXPERIMENTAL

E7386

Intervention Type DRUG

E7386 dosing.

Lenvatinib

Intervention Type DRUG

Lenvatinib dosing.

Dose Expansion Part: HCC Subpart: Lenvatinib Only

Participants with HCC will receive lenvatinib 8 mg (participants with body weight of \<60 kg) or 12 mg (participants with body weight \>=60 kg), capsules, orally, QD in 28-day treatment cycles until PD, development of unacceptable toxicity, participant request to discontinue, withdrawal of consent, or termination of the study program

Group Type EXPERIMENTAL

Lenvatinib

Intervention Type DRUG

Lenvatinib dosing.

Dose Expansion Part: HCC Subpart: E7386 + Lenvatinib

Participants with HCC will receive lenvatinib 8 mg (participants with body weight of \<60 kg) or 12 mg (participants with body weight \>=60 kg), capsule, orally QD in combination with E7386 y, BID in 28-day treatment cycles until PD, development of unacceptable toxicity, participant request to discontinue, withdrawal of consent, or termination of the study program.

Group Type EXPERIMENTAL

E7386

Intervention Type DRUG

E7386 dosing.

Lenvatinib

Intervention Type DRUG

Lenvatinib dosing.

Dose Expansion Part: CRC Subpart: E7386 + Lenvatinib

Participants with colorectal cancer (CRC) will receive E7386, BID in combination with lenvatinib 20 mg, capsules, orally, QD in 28-day treatment cycles until PD, development of unacceptable toxicity, participant request to discontinue, withdrawal of consent, or termination of the study program.

Group Type EXPERIMENTAL

E7386

Intervention Type DRUG

E7386 dosing.

Lenvatinib

Intervention Type DRUG

Lenvatinib dosing.

Dose Expansion Part: EC Subpart: E7386 + Lenvatinib

Participants with endometrial cancer (EC) will receive E7386, BID in combination with lenvatinib 14 mg, capsules, orally, QD in 28-day treatment cycles until PD, development of unacceptable toxicity, participant request to discontinue, withdrawal of consent, or termination of the study program.

Group Type EXPERIMENTAL

E7386

Intervention Type DRUG

E7386 dosing.

Lenvatinib

Intervention Type DRUG

Lenvatinib dosing.

Dose Optimization Part: EC Participants

Participants with EC will be randomized to receive 2 different doses of E7386 in combination with lenvatinib capsule or lenvatinib capsule monotherapy in 28-days cycles, or treatment of physician's choice (TPC; doxorubicin in 21-day cycles or paclitaxel in 28-day cycles \[3 weeks on/1 week off\]), until PD, development of unacceptable toxicity, participant request to discontinue, withdrawal of consent, or termination of the study program.

Group Type EXPERIMENTAL

E7386

Intervention Type DRUG

E7386 dosing.

Lenvatinib

Intervention Type DRUG

Lenvatinib dosing.

Doxorubicin

Intervention Type DRUG

Doxorubicin dosing.

Paclitaxel

Intervention Type DRUG

Paclitaxel dosing.

Interventions

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E7386

E7386 dosing.

Intervention Type DRUG

Lenvatinib

Lenvatinib dosing.

Intervention Type DRUG

Doxorubicin

Doxorubicin dosing.

Intervention Type DRUG

Paclitaxel

Paclitaxel dosing.

Intervention Type DRUG

Other Intervention Names

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Lenvima E7080

Eligibility Criteria

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Inclusion Criteria

1. HCC part only:

Participants with confirmed diagnosis of unresectable HCC with any of the following criteria:
1. Histologically or cytologically confirmed diagnosis of HCC, excluding fibrolamellar, sarcomatoid or mixed cholangio-HCC tumors
2. Clinically confirmed diagnosis of HCC according to American Association for the Study of Liver Diseases (AASLD) criteria, including cirrhosis of any etiology and/or chronic hepatitis B or C infection

ST part only (except for HCC):

Participants with histologically or cytologically confirmed diagnosis of solid tumor for which no alternative standard therapy or no effective therapy exists
2. Life expectancy of \>=12 weeks
3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1
5. Adequate washout period before study drug administration:

1. Chemotherapy and radiotherapy: 3 weeks or 5 times the half-life, whichever is shorter
2. Any antitumor therapy with antibody: 4 weeks or more
3. Any investigational drug or device: 4 weeks or more
4. Blood/platelet transfusion or granulocyte colony-stimulating factor (G-CSF): 2 weeks or more Note: Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not had radiation pneumonitis
6. Adequate controlled blood pressure (BP), renal function, bone marrow function, liver function, and serum mineral level
7. At least one measurable lesion based on mRECIST (for HCC Subparts in Dose Escalation Part) or on RECIST 1.1 (for Other ST Subparts in Dose Escalation Part and all subparts in Expansion and Dose Optimization Parts) meeting following criteria

* At least 1 lesion of \>=1.0 centimeter (cm) in the longest diameter for a non-lymph node or \>=1.5 cm in the short-axis diameter for a lymph node that is serially measurable according to RECIST 1.1 using computerized tomography (CT)/magnetic resonance imaging (MRI)
* Lesions that have had external beam radiotherapy or loco-regional therapies such as radiofrequency ablation, or transarterial chemoembolisation (TACE)/ transarterial embolization (TAE) must show evidence of progressive disease based on RECIST 1.1 to be deemed a target lesion
8. For HCC participants only: Child-Pugh score A. Note: If Child-Pugh score 7 or more was observed during Screening or Baseline, the participant is ineligible and re-assessment of the Child-Pugh score is not permitted
9. For HCC participants only: Participants categorized to stage B (not amenable to locoregional therapy or refractory to locoregional therapy, and not amenable to a curative treatment), or stage C based on Barcelona Clinic Liver Cancer (BCLC) staging system
10. For HCC Subpart in Expansion Part only: prior systemic therapy for locally advanced or metastatic disease is as defined below

a. Participants who have received only one prior line of immuno oncology (IO) based regimen and have progressed on or after prior treatment with IO based regimen, or IO ineligible participants who have received no prior systemic therapy. Participants who previously received lenvatinib treatment are ineligible
11. For CRC Subpart in Expansion Part only: participants must have received at least 2 prior regimens (not exceeding 4 prior regimens) or could not tolerate standard treatment and must have received the following prior therapies in the metastatic setting if approved and locally available (progressed on at least 1 prior regimen in the metastatic setting or could not tolerate standard treatment):

Note: Adjuvant chemotherapy counts as prior systemic treatment if there is documented disease progression within 6 months of treatment completion Note: If a participant is determined to be intolerant to prior standard treatment, the participant must have received at least of 2 cycles of that therapy Note: Participants who have received oral tyrosine kinase inhibitor (example, regorafenib) are ineligible
1. Fluoropyrimidine, irinotecan and oxaliplatin with or without an anti-Vascular endothelial growth factor (VEGF) monoclonal antibody (mAb) (example, bevacizumab) Note: Capecitabine is acceptable as equivalent to fluoropyrimidine in prior treatment Note: Participants who have previously received fluoropyrimidine, oxaliplatin, and irinotecan as part of the same and only chemotherapy regimen, example, FOLFOXIRI or FOLFIRINOX, may be eligible after discussion with the Sponsor
2. Chemotherapy with anti- epidermal growth factor receptor (EGFR) mAb (cetuximab or panitumumab) for participants with rat sarcoma virus (RAS) (Kirsten rat sarcoma viral oncogene homolog \[KRAS)/ NRAS\]) wild type (WT) CRC Note: RAS (KRAS/NRAS) WT participants with right or left CRC lesions who may have not been treated with anti-EGFR mAb based on local guidelines are eligible
3. BRAF inhibitor (in combination with cetuximab ± binimetinib) for BRAF V600E mutated tumors
4. Immune checkpoint inhibitor for participants with microsatellite instability-high (MSI-H) CRC
12. For EC Subpart in Expansion Part only: Participants must have EC that has progressed after 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 have progressed after prior platinum-based chemotherapy are eligible). Up to 3 prior systemic therapies, of which up to 2 for metastatic or locally advanced disease, are permitted Note: There is no restriction regarding prior hormonal therapies For Dose Optimization Part only: Participants must have EC that has progressed after prior platinum-based chemotherapy and an anti-PD-(L)1-directed therapy for EC. Up to 3 lines of prior therapy, regardless of setting, are allowed. Participants must be eligible for treatment with either single-agent paclitaxel or single-agent doxorubicin as determined by the investigator, with consideration of previous therapies received for EC. Note: Prior hormonal therapy and radiation are allowed and do not count as prior lines of therapy.

Exclusion Criteria

1. 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 (%)
2. Major surgery within 21 days or minor surgery (that is, simple excision) within 7 days prior to starting study drug. Participant must have recovered from the surgery related toxicities to less than Grade 2 Note: Adequate wound healing after major surgery must be assessed clinically, independent of time elapsed for eligibility
3. Known to be human immunodeficiency virus (HIV) positive Note: the sponsor has evaluated whether to include participant with HIV. Given that this is the first combination study of E7386 with lenvatinib and that the main mechanism of action of E7386 is immunomodulation of the tumor microenvironment along with the fact that several anti-retroviral therapies have drug-drug interaction with cytochrome P450 3A (CYP3A) substrates, the sponsor has decided not to include these participants at the current time. However, further considerations will be made moving forward based on new emerging data Note: HIV testing is required at screening only when mandated by local health authority
4. Participants with proteinuria on urine dipstick testing will undergo 24-hour urine collection for quantitative assessment of proteinuria. Participants with urine protein \>=1 gram per 24 hour will be ineligible
5. 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 the Screening Period although antiviral therapy for HBV is ongoing
* Has dual active HBV infection (HBsAg (+) and/or detectable HBV deoxyribonucleic acid \[DNA\]) and HCV infection (anti-HCV Ab (+) and detectable HCV ribonucleic acid \[RNA\]) at study entry
6. Diagnosed with meningeal carcinomatosis
7. Participants with central nervous system metastases are only eligible if they have been previously treated and are radiologically stable, (that is, without evidence of progression for at least 4 weeks prior to first dose of study treatment by repeat imaging), clinically stable, and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment
8. Pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring active treatment, including the use of oxygen
9. Any of bone disease/conditions as follows:

* T-score of \< minus (-) 3.0 at the left or right total hip, left or right femoral neck or lumbar spine (L1-L4) as determined by dual energy x-ray absorptiometry (DXA) scan. Participants with T-score \<-2.5 to -3.0 can only be included if treatment with a bisphosphonate (example, zoledronic acid) or denosumab has been started at least 14 days and no more than 6 months prior to the first dose of study drug
* Metabolic bone disease, such as hyperparathyroidism, Paget's disease or osteomalacia
* 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. Participants may be included if treatment with bisphosphonate or denosumab has been started at least 14 days prior to the first dose of study drug. Participants with previous solitary bone lesions controlled with radiotherapy are eligible
* History of symptomatic vertebral fragility fracture or any fragility fracture of the hip, pelvis, wrist or other location (defined as any fracture without a history 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 at baseline
10. History of malignancy (except for original disease, or definitively treated melanoma in-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
11. For HCC Subpart in Dose Escalation Part only: Participants who experienced discontinuation of lenvatinib, 2 or more dose reductions of lenvatinib required from initial dose level of this study due to its toxicity, or participants who experienced single dose reduction or consecutive \>=8 days dose interruption of lenvatinib within 60 days from the first dose, due to its toxicity. HCC Subpart in Expansion Part only: Participants who previously received lenvatinib treatment are ineligible.

EC Subpart in Expansion Part only: Participants previously treated with lenvatinib who experienced discontinuation of lenvatinib due to toxicity, or dose reduction to less than 10 mg of lenvatinib due to toxicity within 60 days from the first dose.

EC Dose Optimization Part only: Participants who previously received lenvatinib treatment are ineligible.
12. Bleeding or thrombotic disorders or use of anticoagulants requiring therapeutic International Normalized Ratio (INR) monitoring for HCC participants only (example, warfarin or similar agents). Treatment with low molecular weight heparin and factor X inhibitors is permitted. Treatment with antiplatelet agents is prohibited for HCC participants in Dose Escalation Part only
13. 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
14. For HCC participants only: History of hepatic encephalopathy within 6 months prior to starting study drug
15. For EC Subpart in Expansion and Dose Optimization Parts only: carcinosarcoma (malignant mixed Mullerian tumor), endometrial leiomyosarcoma, and endometrial stromal sarcomas
16. Has preexisting \>=Grade 3 gastrointestinal or non-gastrointestinal fistula
17. Evidence of current Coronavirus disease 2019 (COVID-19) infection or ongoing unrecovered active sequelae of COVID-19 infection
19. Has a known psychiatric or substance abuse disorder that would interfere with the participant ability to cooperate with the requirements of the study
20. Evidence of clinically significant disease (example, cardiac, respiratory, gastrointestinal, renal disease) that in the opinion of the investigator could affect the participant safety or interfere with the study assessments
21. Scheduled for major surgery during the study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eisai Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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UAMS

Little Rock, Arkansas, United States

Site Status RECRUITING

University of California San Diego (UCSD) - Moores Cancer Center(All)

La Jolla, California, United States

Site Status RECRUITING

Cedars-Sinai Medical Center

Los Angeles, California, United States

Site Status COMPLETED

Pasadena Liver Center

Pasadena, California, United States

Site Status COMPLETED

California Pacific Medical Center

San Francisco, California, United States

Site Status RECRUITING

UCLA University of California - Los Angeles

Santa Monica, California, United States

Site Status ACTIVE_NOT_RECRUITING

John Muir Clinical Research

Walnut Creek, California, United States

Site Status RECRUITING

University of Colorado Cancer Center - Anschutz Medical Campus

Aurora, Colorado, United States

Site Status RECRUITING

Uni. Of Miami- Sylvester Cancer Centre

Miami, Florida, United States

Site Status RECRUITING

Florida Cancer Specialists - South

Sarasota, Florida, United States

Site Status RECRUITING

Florida Cancer Specialists - East

West Palm Beach, Florida, United States

Site Status RECRUITING

Women's Cancer Care - Covington, LA

Covington, Louisiana, United States

Site Status RECRUITING

University Of Mississippi Medical Center

Jackson, Mississippi, United States

Site Status RECRUITING

Kansas City Research Institute

Kansas City, Missouri, United States

Site Status COMPLETED

Perlmutter Cancer Center- NYU Langone Health

New York, New York, United States

Site Status RECRUITING

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status RECRUITING

Montefiore Medical Center (MMC) - Jack D. Weiler Hospital

The Bronx, New York, United States

Site Status RECRUITING

MetroHealth Medical Center

Cleveland, Ohio, United States

Site Status RECRUITING

ProMedica Flower Hospital

Sylvania, Ohio, United States

Site Status RECRUITING

University of Oklahoma Health Science Center

Oklahoma City, Oklahoma, United States

Site Status RECRUITING

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status RECRUITING

Sanford Cancer Centre

Sioux Falls, South Dakota, United States

Site Status RECRUITING

Tennessee Oncology

Nashville, Tennessee, United States

Site Status RECRUITING

Vanderbilt University Medical Center (VUMC) - Vanderbilt-Ingram Cancer Center (VICC) - Nashville

Nashville, Tennessee, United States

Site Status RECRUITING

Mary Crowley Cancer Research

Dallas, Texas, United States

Site Status COMPLETED

University of Texas Southwestern Medical

Dallas, Texas, United States

Site Status RECRUITING

MD Anderson Cancer Center

Houston, Texas, United States

Site Status RECRUITING

Fred Hutchinson/University of Washington Cancer Consortium

Seattle, Washington, United States

Site Status RECRUITING

Sunnybrook Research Institute

Toronto, Ontario, Canada

Site Status RECRUITING

CHUM, Unit for Innovative Therapies

Montreal, Quebec, Canada

Site Status RECRUITING

McGill University Health Centre

Montreal, Quebec, Canada

Site Status RECRUITING

Beijing Cancer Hospital

Beijing, , China

Site Status RECRUITING

Peking Union Medical College Hospital

Beijing, , China

Site Status RECRUITING

The First Bethune Hospital of Jilin University

Changchun, , China

Site Status RECRUITING

Fujian Provincial Cancer Hospital

Fuzhou, , China

Site Status RECRUITING

Sun Yan-sen University Cancer Center

Guangzhou, , China

Site Status RECRUITING

Sun Yat-Sen Memrial Hospital, Sun Yat-Sen University

Guangzhou, , China

Site Status RECRUITING

Cancer Hospital of Shandong First Medical University

Jinan, , China

Site Status RECRUITING

Yunnan Cancer Hospital

Kunming, , China

Site Status RECRUITING

Fudan University Cancer Center

Shanghai, , China

Site Status RECRUITING

The Tenth People's Hospital; Shanghai Tongji University

Shanghai, , China

Site Status RECRUITING

Cancer Hospital Chinese Academy of Medical Sciences, Shenzhen Center

Shenzhen, , China

Site Status RECRUITING

Tianjin Cancer Hospital

Tianjin, , China

Site Status RECRUITING

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, , China

Site Status RECRUITING

Odense University Hospital

Odense, , Denmark

Site Status RECRUITING

CHU Amiens-Picardie (Hopital Sud)

Amiens, , France

Site Status COMPLETED

CHU Bordeaux

Bordeaux, , France

Site Status RECRUITING

CHU Cavale Blanche

Brest, , France

Site Status RECRUITING

Centre Fran ois Baclesse

Caen, , France

Site Status RECRUITING

Centre Jean Perrin

Clermont-Ferrand, , France

Site Status RECRUITING

H pital Beaujon

Clichy, , France

Site Status ACTIVE_NOT_RECRUITING

Centre Georges-Fran ois Leclerc

Dijon, , France

Site Status RECRUITING

Grenoble University Hospital (Centre Hospitalier Universitaire Grenoble Alpes)

La Tronche, , France

Site Status RECRUITING

CHU de LILLE - H pital HURIEZ

Lille, , France

Site Status ACTIVE_NOT_RECRUITING

Hepatology, Hopital de la Croix-Rousse - 103 grande rue de la Croix-Rousse

Lyon, , France

Site Status ACTIVE_NOT_RECRUITING

Centre L on B rard

Lyon, , France

Site Status RECRUITING

Institut Paoli-Calmettes

Marseille, , France

Site Status WITHDRAWN

Centre Antoine Lacassagne

Nice, , France

Site Status RECRUITING

Institut Curie - Centre de Recherche

Paris, , France

Site Status RECRUITING

APHP Hospital Saint-Antoine

Paris, , France

Site Status ACTIVE_NOT_RECRUITING

AP-HP Universit de Paris, Port Royal

Paris, , France

Site Status RECRUITING

Hopital Europeen Georges-Pompidou (HEGP)

Paris, , France

Site Status RECRUITING

Hopital de la Croix Saint-Simon

Paris, , France

Site Status RECRUITING

Centre Hospitalier Universitaire de Bordeaux (CHU Bordeaux)(Hopitaux de Bordeaux) - Groupe hospitalier Sud - Hopital Haut-Levequ

Pessac, , France

Site Status ACTIVE_NOT_RECRUITING

Centre Hospitalier Universitaire (CHU) de Poitiers

Poitiers, , France

Site Status RECRUITING

Insitute de Canc rologie de l'Ouest - Centre Ren Gauducheau

Saint-Herblain, , France

Site Status RECRUITING

ICANs

Strasbourg, , France

Site Status RECRUITING

Gustave Roussy Institute (IGR)

Villejuif, , France

Site Status RECRUITING

Clinica Oncologica AOU (Azienda Ospedaliero Universitaria) delle Marche

Ancona, , Italy

Site Status RECRUITING

Istituto Clinico Humanitas, Rozzano

Milan, , Italy

Site Status RECRUITING

Fondazione Policlinico Gemelli IRCCS

Rome, , Italy

Site Status RECRUITING

Eisai#1005

Nagoya, Aichi-ken, Japan

Site Status RECRUITING

Eisai#1011

Toyoake, Aichi-ken, Japan

Site Status RECRUITING

Eisai#1002

Kashiwa, Chiba, Japan

Site Status RECRUITING

Eisai#1008

Matsuyama, Ehime, Japan

Site Status COMPLETED

Eisai#1007

Kurume, Fukuoka, Japan

Site Status RECRUITING

Eisai#1013

Akashi, Hyōgo, Japan

Site Status RECRUITING

Eisai#1010

Kawasaki, Kanagawa, Japan

Site Status ACTIVE_NOT_RECRUITING

Eisai#1012

Kamigyō-ku, Kyoto, Japan

Site Status COMPLETED

Eisai#1003

Sayama, Osaka, Japan

Site Status COMPLETED

Eisai#1009

Hidaka, Saitama, Japan

Site Status RECRUITING

Eisai#1001

Chuo-ku, Tokyo, Japan

Site Status RECRUITING

Eisai#1006

Koto-ku, Tokyo, Japan

Site Status RECRUITING

Eisai#1015

Minato-ku, Tokyo, Japan

Site Status RECRUITING

Eisai#1004

Chiba, , Japan

Site Status COMPLETED

Eisai#1014

Niigata, , Japan

Site Status RECRUITING

Korea University Guro Hospital

Guro-gu, , South Korea

Site Status RECRUITING

National Cancer Center

Ilsandong-gu, , South Korea

Site Status RECRUITING

Seoul National University Hospital

Jongno-gu, , South Korea

Site Status COMPLETED

Seoul National University Hospital

Jongno-gu, , South Korea

Site Status RECRUITING

Seoul St. Mary's Hospital

Seocho-Gu, , South Korea

Site Status RECRUITING

Severance Hospital (Yonsei University Medical Center)

Seodaemun, , South Korea

Site Status RECRUITING

Seoul National University Bundang Hospital

Seongnamsi Bundang, , South Korea

Site Status ACTIVE_NOT_RECRUITING

Samsung Medical Center

Seoul, , South Korea

Site Status RECRUITING

Asan Medical Center

Songpa-Gu, , South Korea

Site Status RECRUITING

University of Ulsan College of Medicine - Asan Medical Center (AMC)

Songpa-gu, , South Korea

Site Status ACTIVE_NOT_RECRUITING

University Hospital A Coru a

A Coruña, , Spain

Site Status RECRUITING

Fundaci Privada Institut d Investigaci Oncol gica de Vall-Hebron (VHIO)

Barcelona, , Spain

Site Status RECRUITING

Hospital Universitario de Ja n

Jaén, , Spain

Site Status RECRUITING

Cl nica Universidad de Navarra

Madrid, , Spain

Site Status RECRUITING

H. Clinico San Carlos

Madrid, , Spain

Site Status RECRUITING

Hospital Universitario 12 de Octubre

Madrid, , Spain

Site Status RECRUITING

Chang Gung Medical Foundation - Kaohsiung Branch

Kaohsiung City, , Taiwan

Site Status ACTIVE_NOT_RECRUITING

Taichung Veterans General Hospital

Taichung, , Taiwan

Site Status RECRUITING

National Cheng Kung University Hospital

Tainan, , Taiwan

Site Status COMPLETED

National Taiwan University Hospital

Taipei, , Taiwan

Site Status ACTIVE_NOT_RECRUITING

Taipei Veterans General Hospital

Taipei, , Taiwan

Site Status COMPLETED

Chang Gung Medical Foundation - Linkou Branch

Taoyuan District, , Taiwan

Site Status ACTIVE_NOT_RECRUITING

Countries

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United States Canada China Denmark France Italy Japan South Korea Spain Taiwan

Central Contacts

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Eisai Inquiry Service

Role: CONTACT

Email: [email protected]

References

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Mesropian A, Gris-Oliver A, Balaseviciute U, Potdar AA, Kimura T, Shen J, Torres-Marcen M, Abril-Fornaguera J, Pique-Gili M, Camell-Raventos D, Peix J, Fernandez-Martinez E, Huguet-Pradell J, Hernandez de Sande A, Keraite I, Esteban-Fabro R, Barcena-Varela M, Lindblad KE, Lujambio A, Guccione E, Thung S, Ikeda M, Kudo M, Sia D, Pinyol R, Llovet JM. E7386 enhances lenvatinib's antitumor activity in preclinical models and human hepatocellular carcinoma. Clin Cancer Res. 2025 Sep 23. doi: 10.1158/1078-0432.CCR-25-0725. Online ahead of print.

Reference Type DERIVED
PMID: 40986544 (View on PubMed)

Eskander RN, Lee JY, Mirza MR, Lorusso D, MacKay H, Ray-Coquard I, Oaknin A, Gonzalez-Martin A, Hasegawa K, Corr BR, Wu X, Leary A, Hu T, Dutta L, Okpara CE, McKenzie J, Makker V. Randomized study evaluating optimal dose, efficacy, and safety of E7386 plus lenvatinib versus treatment of physician's choice in advanced/recurrent endometrial carcinoma previously treated with platinum-based chemotherapy and immune checkpoint inhibitors. Int J Gynecol Cancer. 2025 Sep;35(9):101812. doi: 10.1016/j.ijgc.2025.101812. Epub 2025 Apr 5.

Reference Type DERIVED
PMID: 40318924 (View on PubMed)

Other Identifiers

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2022-003300-32

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2023-510275-64-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

E7386-J081-102

Identifier Type: -

Identifier Source: org_study_id