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

Primary Purpose

Neoplasms, Carcinoma, Hepatocellular, Liver Neoplasms

Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
E7386
Lenvatinib
Sponsored by
Eisai Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neoplasms focused on measuring Solid Tumor, Hepatocellular carcinoma, Endometrial cancer, Colorectal cancer, E7386, Lenvatinib

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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
  4. All AEs due to previous anti-cancer therapy have either returned to Grade 0 to 1 except for alopecia or up to Grade 2 peripheral neuropathy (renal/bone marrow/liver function should meet the inclusion criteria)
  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 Part) 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 who have radiographic evidence of disease progression after prior systemic therapies. Participants must have received platinum-based chemotherapy regimen and/or IO based regimen (example, lenvatinib + pembrolizumab or pembrolizumab monotherapy) for EC. Participants may have received up to 1 additional line of platinum-based chemotherapy if given in the neoadjuvant or adjuvant treatment setting, but not exceeding 3 lines of therapies. If participants are ineligible for IO therapy, participants who have received only 1 prior systemic therapy including platinum based chemotherapy regimen are eligible Note: There is no restriction regarding prior hormonal therapy

Exclusion Criteria:

  1. Any of cardiac conditions as follows:

    1. Heart failure New York Heart Association (NYHA) Class II or above
    2. Unstable ischaemic heart disease (myocardial infarction within 6 months prior to starting study drug, or angina requiring use of nitrates more than once weekly)
    3. Prolongation of QT interval with Fridericias correction (QTcF) to greater than (>) 480 millisecond (msec)
    4. 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 >1 positive 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:

    • Osteoporosis with T-score of < minus (-) 2.5 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
    • 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 Subparts in Dose Escalation Part and EC Subpart in Expansion Part only: Participants who experienced discontinuation of lenvatinib, 2 or more multiple 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. If participants previously started at lower dose level of lenvatinib (that is, 14 mg QD in EC) and had no dose reduction are eligible after discussion with the Sponsor, if participants can start at initial dose level of this study based on investigators judgement
  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 Part 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 COVID-19 infection or ongoing unrecovered active sequelae of COVID-19 infection
  18. Males who have not had a successful vasectomy (confirmed azoospermia) if their female partners meet the exclusion criteria above (that is, the female partners are of childbearing potential and are not willing to use a highly effective contraceptive method throughout the study period and for 30 days after study drug discontinuation). No sperm donation is allowed during the study period and for 30 days after study drug discontinuation
  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

Sites / Locations

  • University of California San Diego (UCSD) - Moores Cancer Center(All)
  • Cedars-Sinai Medical Center
  • UCLA University of California - Los Angeles
  • University of Colorado Cancer Center - Anschutz Medical Campus
  • Florida Cancer Specialists - South
  • Florida Cancer Specialists - East
  • Kansas City Research Institute
  • Memorial Sloan Kettering Cancer Center
  • University of Oklahoma Health Science Center
  • Medical University of South Carolina
  • Vanderbilt University Medical Center (VUMC) - Vanderbilt-Ingram Cancer Center (VICC) - Nashville
  • Mary Crowley Cancer ResearchRecruiting
  • University of Texas Southwestern Medical
  • MD Anderson Cancer CenterRecruiting
  • CHU Amiens-Picardie (Hopital Sud)Recruiting
  • CHU de LILLE - Hôpital HURIEZ
  • Hepatology, Hopital de la Croix-Rousse - 103 grande rue de la Croix-RousseRecruiting
  • APHP Hospital Saint-AntoineRecruiting
  • Centre Hospitalier Universitaire de Bordeaux (CHU Bordeaux)(Hopitaux de Bordeaux) - Groupe hospitalier Sud - Hopital Haut-LevequRecruiting
  • Eisai Trial Site #5Recruiting
  • Eisai Trial Site #11Recruiting
  • Eisai Trial Site #2Recruiting
  • Eisai Trial Site #8Recruiting
  • Eisai Trial Site #7Recruiting
  • Eisai Trial Site #10Recruiting
  • Eisai Trial Site #12Recruiting
  • Eisai Trial Site #3Recruiting
  • Eisai Trial Site #9Recruiting
  • Eisai Trial Site #1Recruiting
  • Eisai Trial Site #6Recruiting
  • Eisai Trial Site #4Recruiting
  • Eisai Trial Site #1Recruiting
  • Eisai Trial Site #5Recruiting
  • Eisai Trial Site #2Recruiting
  • Eisai Trial Site #4Recruiting
  • Eisai Trial Site #3Recruiting
  • Chang Gung Medical Foundation - Kaohsiung Branch
  • Taichung Veterans General HospitalRecruiting
  • National Cheng Kung University HospitalRecruiting
  • National Taiwan University HospitalRecruiting
  • Taipei Veterans General HospitalRecruiting
  • Chang Gung Medical Foundation - Linkou BranchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Dose Escalation Part: HCC: E7386 QD Subpart + Lenvatinib

Dose Escalation Part: HCC: E7386 BID Subpart + Lenvatinib

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

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

Dose Expansion Part: HCC Subpart: Lenvatinib Only

Dose Expansion Part: HCC Subpart: E7386 + Lenvatinib

Dose Expansion Part: CRC Subpart: E7386 + Lenvatinib

Dose Expansion Part: EC Subpart: E7386 + Lenvatinib

Arm Description

Participants with hepatocellular carcinoma (HCC) will receive E7386 tablets, orally, QD for 5 or 6 consecutive days followed by 48 hours of without treatment in Cycle 0 (6 or 7 days). Participants with HCC will receive E7386 tablets, orally, QD in combination with lenvatinib 8 milligram (mg) (participants with body weight of less than [<] 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. Dose escalation of E7386 will be based on the available safety data from the previous cohorts.

Participants with HCC will receive E7386 tablets, orally, BID for 5 or 6 consecutive days in Cycle 0 (6 or 7 days). Participants with HCC will receive E7386 tablets, orally, 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. Dose escalation of E7386 will be based on the available safety data from the previous cohorts.

Participants with solid tumor (ST) (except for HCC) will receive E7386 tablets, alone orally, QD for 5 or 6 consecutive days followed by 48 hours of without treatment in Cycle 0 (6 or 7 days). Participants with ST (except for HCC) will receive E7386 tablets, orally, 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. Dose escalation of E7386 will be based on the available safety data from the previous cohorts.

Participants with ST (except for HCC) will receive E7386 tablets, alone orally, BID for 5 or 6 consecutive days in Cycle 0 (6 or 7 days). Participants with ST (except for HCC) will receive E7386 tablets, orally, 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. Dose escalation of E7386 will be based on the available safety data from the previous cohorts.

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.

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 tablets, orally, 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. E7386 dose will be determined from recommended dose level of the HCC BID Subpart in Dose Escalation Part.

Participants with colorectal cancer (CRC) will receive E7386 tablets, orally, 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. E7386 dose will be determined from recommended dose level of the ST BID Subpart in Dose Escalation Part.

Participants with endometrial cancer (EC) will receive E7386 tablets, orally, 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. E7386 dose will be determined from recommended dose level of the ST BID Subpart in Dose Escalation Part.

Outcomes

Primary Outcome Measures

Dose Escalation Part: Number of Participants with Dose-limiting Toxicities (DLTs)
DLT will be defined as any of the events that are considered by the investigator to be at least possibly related to therapy with the study medication. Toxicity will be evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE 5.0).
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

Secondary Outcome Measures

Dose Escalation Part: Cmax: Maximum Observed Plasma Concentration for E7386
Here BID is twice daily and QD is once daily.
Dose Escalation Part: Cmax: Maximum Observed Plasma Concentration for Lenvatinib
Dose Escalation Part: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for E7386
Dose Escalation Part: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Lenvatinib
Dose Escalation Part: AUC: Area Under the Plasma Concentration Versus Time Curve for E7386
Dose Escalation Part: AUC: Area Under the Plasma Concentration Versus Time Curve for Lenvatinib
Dose Escalation Part: CL/F: Apparent Total Body Clearance for E7386
Dose Escalation Part: CL/F: Apparent Total Body Clearance for Lenvatinib
Dose Escalation Part: Vz/F: Apparent Volume of Distribution for E7386
Dose Escalation Part: Vz/F: Apparent Volume of Distribution for Lenvatinib
Percentage of Participants with Best Overall Response (BOR)
BOR is defined as confirmed complete response (CR), confirmed partial response (PR), stable disease (SD), PD, and not evaluable (NE), where SD has to be achieved at greater than or equal to (>=) 7 weeks after the first dose. The BOR will be assessed by investigator based on Modified Response Evaluation Criteria in Solid Tumors (mRECIST) for HCC subparts in dose escalation part and based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 for ST subparts in dose escalation part, and for HCC subpart, CRC subpart, EC subpart in dose expansion part.
Objective Response Rate (ORR)
The ORR is defined as the percentage of participants with a BOR of CR or PR. The ORR will be assessed by investigator based on mRECIST for HCC subparts in dose escalation part and based on RECIST version 1.1 for ST-subparts in dose escalation part, and for HCC subpart, CRC subpart, EC subpart in dose expansion part.
Disease Control Rate (DCR)
DCR is defined as the percentage of participants with a BOR of CR, PR, or SD after >=7 weeks from the first dose. The DCR will be assessed by investigator based on mRECIST for HCC subparts in dose escalation part and based on RECIST version 1.1 for ST-subparts in dose escalation part, and for HCC subpart, CRC subpart, EC subpart in dose expansion part.
Clinical Benefit Rate (CBR)
The CBR is defined as the percentage of participants with a BOR of CR, PR, or durable SD (duration of SD >=23 weeks). The CBR will be assessed by investigator based on mRECIST for HCC subparts in dose escalation part and based on RECIST version 1.1 for ST-subparts in dose escalation part, and for HCC subpart, CRC subpart, EC subpart in dose expansion part.
Progression-free Survival (PFS)
PFS is defined as the time from the date of the first dose to the date of the first documentation of confirmed PD or death, whichever occurs first.
Overall Survival (OS)
OS is defined as the time from the first dose of study drug to death due to any cause. OS will be calculated for all subparts in dose expansion part and HCC subparts in dose escalation part only.
Duration of Response (DOR)
DOR is defined as the time from the first documentation of PR or CR to the first documentation of disease progression or death due to any cause (whichever occurs first).

Full Information

First Posted
June 24, 2019
Last Updated
September 14, 2023
Sponsor
Eisai Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04008797
Brief Title
A Study of E7386 in Combination With Other Anticancer Drug in Participants With Solid Tumor
Official Title
An Open-label Phase 1b Study of E7386 in Combination With Other Anticancer Drug(s) in Subjects With Solid Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 11, 2019 (Actual)
Primary Completion Date
October 31, 2024 (Anticipated)
Study Completion Date
October 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eisai Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasms, Carcinoma, Hepatocellular, Liver Neoplasms, Colorectal Neoplasms, Endometrial Neoplasms
Keywords
Solid Tumor, Hepatocellular carcinoma, Endometrial cancer, Colorectal cancer, E7386, Lenvatinib

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
181 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dose Escalation Part: HCC: E7386 QD Subpart + Lenvatinib
Arm Type
Experimental
Arm Description
Participants with hepatocellular carcinoma (HCC) will receive E7386 tablets, orally, QD for 5 or 6 consecutive days followed by 48 hours of without treatment in Cycle 0 (6 or 7 days). Participants with HCC will receive E7386 tablets, orally, QD in combination with lenvatinib 8 milligram (mg) (participants with body weight of less than [<] 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. Dose escalation of E7386 will be based on the available safety data from the previous cohorts.
Arm Title
Dose Escalation Part: HCC: E7386 BID Subpart + Lenvatinib
Arm Type
Experimental
Arm Description
Participants with HCC will receive E7386 tablets, orally, BID for 5 or 6 consecutive days in Cycle 0 (6 or 7 days). Participants with HCC will receive E7386 tablets, orally, 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. Dose escalation of E7386 will be based on the available safety data from the previous cohorts.
Arm Title
Dose Escalation Part: Other ST: E7386 QD Subpart + Lenvatinib
Arm Type
Experimental
Arm Description
Participants with solid tumor (ST) (except for HCC) will receive E7386 tablets, alone orally, QD for 5 or 6 consecutive days followed by 48 hours of without treatment in Cycle 0 (6 or 7 days). Participants with ST (except for HCC) will receive E7386 tablets, orally, 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. Dose escalation of E7386 will be based on the available safety data from the previous cohorts.
Arm Title
Dose Escalation Part: Other ST: E7386 BID Subpart + Lenvatinib
Arm Type
Experimental
Arm Description
Participants with ST (except for HCC) will receive E7386 tablets, alone orally, BID for 5 or 6 consecutive days in Cycle 0 (6 or 7 days). Participants with ST (except for HCC) will receive E7386 tablets, orally, 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. Dose escalation of E7386 will be based on the available safety data from the previous cohorts.
Arm Title
Dose Expansion Part: HCC Subpart: Lenvatinib Only
Arm Type
Experimental
Arm Description
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.
Arm Title
Dose Expansion Part: HCC Subpart: E7386 + Lenvatinib
Arm Type
Experimental
Arm Description
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 tablets, orally, 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. E7386 dose will be determined from recommended dose level of the HCC BID Subpart in Dose Escalation Part.
Arm Title
Dose Expansion Part: CRC Subpart: E7386 + Lenvatinib
Arm Type
Experimental
Arm Description
Participants with colorectal cancer (CRC) will receive E7386 tablets, orally, 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. E7386 dose will be determined from recommended dose level of the ST BID Subpart in Dose Escalation Part.
Arm Title
Dose Expansion Part: EC Subpart: E7386 + Lenvatinib
Arm Type
Experimental
Arm Description
Participants with endometrial cancer (EC) will receive E7386 tablets, orally, 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. E7386 dose will be determined from recommended dose level of the ST BID Subpart in Dose Escalation Part.
Intervention Type
Drug
Intervention Name(s)
E7386
Intervention Description
E7386, tablets, orally.
Intervention Type
Drug
Intervention Name(s)
Lenvatinib
Other Intervention Name(s)
Lenvima, E7080, Kisplyx
Intervention Description
Lenvatinib, capsules, orally.
Primary Outcome Measure Information:
Title
Dose Escalation Part: Number of Participants with Dose-limiting Toxicities (DLTs)
Description
DLT will be defined as any of the events that are considered by the investigator to be at least possibly related to therapy with the study medication. Toxicity will be evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE 5.0).
Time Frame
Cycle 0 (Cycle 0 length=6 or 7 days) up to Cycle 1 (Cycle 1 length=28 days)
Title
Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame
Up to 30 days after the last dose of study drug or before initiating post anti-cancer treatment (up to approximately 60 months)
Secondary Outcome Measure Information:
Title
Dose Escalation Part: Cmax: Maximum Observed Plasma Concentration for E7386
Description
Here BID is twice daily and QD is once daily.
Time Frame
QD Subpart-Cycle 0 Day 1: 0-24 hours post-dose; Cycle 0 Day 5: 0-48 hours post-dose; Cycle 1 Day 8: 0-24 hours post-dose; BID Subpart-Cycle 0 Day 1 Day 5: 0-12 hours post-dose; Cycle 1 Day 8: 0-12 hours post-dose (Cycle 0=6 or 7 days, Cycle 1=28 days)
Title
Dose Escalation Part: Cmax: Maximum Observed Plasma Concentration for Lenvatinib
Time Frame
Cycle 1 Day 8: 0-24 hours post-dose (Cycle 1 length=28 days)
Title
Dose Escalation Part: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for E7386
Time Frame
QD Subpart-Cycle 0 Day 1: 0-24 hours post-dose; Cycle 0 Day 5: 0-48 hours post-dose; Cycle 1 Day 8: 0-24 hours post-dose; BID Subpart-Cycle 0 Day 1 Day 5: 0-12 hours post-dose; Cycle 1 Day 8: 0-12 hours post-dose (Cycle 0=6 or 7 days, Cycle 1=28 days)
Title
Dose Escalation Part: Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Lenvatinib
Time Frame
Cycle 1 Day 8: 0-24 hours post-dose (Cycle 1 length=28 days)
Title
Dose Escalation Part: AUC: Area Under the Plasma Concentration Versus Time Curve for E7386
Time Frame
QD Subpart-Cycle 0 Day 1: 0-24 hours post-dose; Cycle 0 Day 5: 0-48 hours post-dose; Cycle 1 Day 8: 0-24 hours post-dose; BID Subpart-Cycle 0 Day 1 Day 5: 0-12 hours post-dose; Cycle 1 Day 8: 0-12 hours post-dose (Cycle 0=6 or 7 days, Cycle 1=28 days)
Title
Dose Escalation Part: AUC: Area Under the Plasma Concentration Versus Time Curve for Lenvatinib
Time Frame
Cycle 1 Day 8: 0-24 hours post-dose (Cycle 1 length=28 days)
Title
Dose Escalation Part: CL/F: Apparent Total Body Clearance for E7386
Time Frame
QD Subpart-Cycle 0 Day 1: 0-24 hours post-dose; Cycle 0 Day 5: 0-48 hours post-dose; Cycle 1 Day 8: 0-24 hours post-dose; BID Subpart-Cycle 0 Day 1 Day 5: 0-12 hours post-dose; Cycle 1 Day 8: 0-12 hours post-dose (Cycle 0=6 or 7 days, Cycle 1=28 days)
Title
Dose Escalation Part: CL/F: Apparent Total Body Clearance for Lenvatinib
Time Frame
Cycle 1 Day 8: 0-24 hours post-dose (Cycle 1 length=28 days)
Title
Dose Escalation Part: Vz/F: Apparent Volume of Distribution for E7386
Time Frame
QD Subpart-Cycle 0 Day 1: 0-24 hours post-dose; Cycle 0 Day 5: 0-48 hours post-dose; Cycle 1 Day 8: 0-24 hours post-dose; BID Subpart-Cycle 0 Day 1 Day 5: 0-12 hours post-dose; Cycle 1 Day 8: 0-12 hours post-dose (Cycle 0=6 or 7 days, Cycle 1=28 days)
Title
Dose Escalation Part: Vz/F: Apparent Volume of Distribution for Lenvatinib
Time Frame
Cycle 1 Day 8: 0-24 hours post-dose (Cycle 1 length=28 days)
Title
Percentage of Participants with Best Overall Response (BOR)
Description
BOR is defined as confirmed complete response (CR), confirmed partial response (PR), stable disease (SD), PD, and not evaluable (NE), where SD has to be achieved at greater than or equal to (>=) 7 weeks after the first dose. The BOR will be assessed by investigator based on Modified Response Evaluation Criteria in Solid Tumors (mRECIST) for HCC subparts in dose escalation part and based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 for ST subparts in dose escalation part, and for HCC subpart, CRC subpart, EC subpart in dose expansion part.
Time Frame
From first dose of study drug until progression of disease (PD), development of unacceptable toxicity, participant requests to discontinue, withdrawal of consent or study termination (up to approximately 60 months)
Title
Objective Response Rate (ORR)
Description
The ORR is defined as the percentage of participants with a BOR of CR or PR. The ORR will be assessed by investigator based on mRECIST for HCC subparts in dose escalation part and based on RECIST version 1.1 for ST-subparts in dose escalation part, and for HCC subpart, CRC subpart, EC subpart in dose expansion part.
Time Frame
From first dose of study drug until PD, development of unacceptable toxicity, participant requests to discontinue, withdrawal of consent or study termination (up to approximately 60 months)
Title
Disease Control Rate (DCR)
Description
DCR is defined as the percentage of participants with a BOR of CR, PR, or SD after >=7 weeks from the first dose. The DCR will be assessed by investigator based on mRECIST for HCC subparts in dose escalation part and based on RECIST version 1.1 for ST-subparts in dose escalation part, and for HCC subpart, CRC subpart, EC subpart in dose expansion part.
Time Frame
From first dose of study drug until PD, development of unacceptable toxicity, participant requests to discontinue, withdrawal of consent or study termination (up to approximately 60 months)
Title
Clinical Benefit Rate (CBR)
Description
The CBR is defined as the percentage of participants with a BOR of CR, PR, or durable SD (duration of SD >=23 weeks). The CBR will be assessed by investigator based on mRECIST for HCC subparts in dose escalation part and based on RECIST version 1.1 for ST-subparts in dose escalation part, and for HCC subpart, CRC subpart, EC subpart in dose expansion part.
Time Frame
From first dose of study drug until PD, development of unacceptable toxicity, participant requests to discontinue, withdrawal of consent or study termination (up to approximately 60 months)
Title
Progression-free Survival (PFS)
Description
PFS is defined as the time from the date of the first dose to the date of the first documentation of confirmed PD or death, whichever occurs first.
Time Frame
From first dose of study drug until PD, or death from any cause, whichever occurs first (up to approximately 60 months)
Title
Overall Survival (OS)
Description
OS is defined as the time from the first dose of study drug to death due to any cause. OS will be calculated for all subparts in dose expansion part and HCC subparts in dose escalation part only.
Time Frame
From first dose of study drug until death from any cause (up to approximately 60 months)
Title
Duration of Response (DOR)
Description
DOR is defined as the time from the first documentation of PR or CR to the first documentation of disease progression or death due to any cause (whichever occurs first).
Time Frame
From first dose of study drug until PD, or death from any cause, whichever occurs first (up to approximately 60 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: HCC part only: Participants with confirmed diagnosis of unresectable HCC with any of the following criteria: Histologically or cytologically confirmed diagnosis of HCC, excluding fibrolamellar, sarcomatoid or mixed cholangio-HCC tumors 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 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 1 except for alopecia or up to Grade 2 peripheral neuropathy (renal/bone marrow/liver function should meet the inclusion criteria) Adequate washout period before study drug administration: Chemotherapy and radiotherapy: 3 weeks or 5 times the half-life, whichever is shorter 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): 2 weeks or more Note: Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not had radiation pneumonitis Adequate controlled blood pressure (BP), renal function, bone marrow function, liver function, and serum mineral level 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 Part) 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 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. 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 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 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 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 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 BRAF inhibitor (in combination with cetuximab ± binimetinib) for BRAF V600E mutated tumors Immune checkpoint inhibitor for participants with microsatellite instability-high (MSI-H) CRC For EC Subpart in Expansion Part only: Participants who have radiographic evidence of disease progression after prior systemic therapies. Participants must have received platinum-based chemotherapy regimen and IO based regimen (example, lenvatinib + pembrolizumab or pembrolizumab monotherapy) for EC. Participants may have received up to 1 additional line of platinum-based chemotherapy if given in the neoadjuvant or adjuvant treatment setting, but not exceeding 3 lines of therapies. If participants are ineligible for IO therapy, participants who have received only 1 prior systemic therapy including platinum based chemotherapy regimen are eligible Note: There is no restriction regarding prior hormonal therapy Exclusion Criteria: Any of cardiac conditions as follows: Heart failure New York Heart Association (NYHA) Class II or above Unstable ischaemic heart disease (myocardial infarction within 6 months prior to starting study drug, or angina requiring use of nitrates more than once weekly) 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 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 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 Participants with proteinuria >1 positive 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 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 Diagnosed with meningeal carcinomatosis 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. Pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring active treatment, including the use of oxygen Any of bone disease/conditions as follows: Osteoporosis with 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 and no prior medical therapy for osteoporosis can only be included if treatment with a bisphosphonate (example, zoledronic acid) or denosumab has been started at least 14 days 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 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 For HCC Subpart in Dose Escalation Part only: Participants who experienced discontinuation of lenvatinib, 2 or more multiple 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. 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 14 mg of lenvatinib due to toxicity 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 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 prior to starting study drug For EC Subpart in Expansion Part only: carcinosarcoma (malignant mixed Mullerian tumor), endometrial leiomyosarcoma, and endometrial stromal sarcomas Has preexisting >=Grade 3 gastrointestinal or non-gastrointestinal fistula Evidence of current COVID-19 infection or ongoing unrecovered active sequelae of COVID-19 infection Males who have not had a successful vasectomy (confirmed azoospermia) if their female partners meet the exclusion criteria above (that is, the female partners are of childbearing potential and are not willing to use a highly effective contraceptive method throughout the study period and for 90 days after study drug discontinuation). No sperm donation is allowed during the study period and for 90 days after study drug discontinuation Has a known psychiatric or substance abuse disorder that would interfere with the participant 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 could affect the participant safety or interfere with the study assessments Scheduled for major surgery during the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eisai Inquiry Service
Email
eisai-chiken_hotline@hhc.eisai.co.jp
Facility Information:
Facility Name
University of California San Diego (UCSD) - Moores Cancer Center(All)
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
UCLA University of California - Los Angeles
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
University of Colorado Cancer Center - Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Florida Cancer Specialists - South
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34236
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Florida Cancer Specialists - East
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33401
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Kansas City Research Institute
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
University of Oklahoma Health Science Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Vanderbilt University Medical Center (VUMC) - Vanderbilt-Ingram Cancer Center (VICC) - Nashville
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Mary Crowley Cancer Research
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Texas Southwestern Medical
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
CHU Amiens-Picardie (Hopital Sud)
City
Amiens
ZIP/Postal Code
80000
Country
France
Individual Site Status
Recruiting
Facility Name
CHU de LILLE - Hôpital HURIEZ
City
Lille
ZIP/Postal Code
59037
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Hepatology, Hopital de la Croix-Rousse - 103 grande rue de la Croix-Rousse
City
Lyon
ZIP/Postal Code
69004
Country
France
Individual Site Status
Recruiting
Facility Name
APHP Hospital Saint-Antoine
City
Paris
ZIP/Postal Code
75012
Country
France
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Universitaire de Bordeaux (CHU Bordeaux)(Hopitaux de Bordeaux) - Groupe hospitalier Sud - Hopital Haut-Levequ
City
Pessac
ZIP/Postal Code
33604
Country
France
Individual Site Status
Recruiting
Facility Name
Eisai Trial Site #5
City
Nagoya
State/Province
Aichi
Country
Japan
Individual Site Status
Recruiting
Facility Name
Eisai Trial Site #11
City
Toyoake
State/Province
Aichi
Country
Japan
Individual Site Status
Recruiting
Facility Name
Eisai Trial Site #2
City
Kashiwa
State/Province
Chiba
Country
Japan
Individual Site Status
Recruiting
Facility Name
Eisai Trial Site #8
City
Matsuyama
State/Province
Ehime
Country
Japan
Individual Site Status
Recruiting
Facility Name
Eisai Trial Site #7
City
Kurume
State/Province
Fukuoka
Country
Japan
Individual Site Status
Recruiting
Facility Name
Eisai Trial Site #10
City
Kawasaki
State/Province
Kanagawa
Country
Japan
Individual Site Status
Recruiting
Facility Name
Eisai Trial Site #12
City
Kamigyo-ku
State/Province
Kyoto
Country
Japan
Individual Site Status
Recruiting
Facility Name
Eisai Trial Site #3
City
Osakasayama
State/Province
Osaka
Country
Japan
Individual Site Status
Recruiting
Facility Name
Eisai Trial Site #9
City
Hidaka
State/Province
Saitama
Country
Japan
Individual Site Status
Recruiting
Facility Name
Eisai Trial Site #1
City
Chuo-Ku
State/Province
Tokyo
Country
Japan
Individual Site Status
Recruiting
Facility Name
Eisai Trial Site #6
City
Koto-ku
State/Province
Tokyo
Country
Japan
Individual Site Status
Recruiting
Facility Name
Eisai Trial Site #4
City
Chiba
Country
Japan
Individual Site Status
Recruiting
Facility Name
Eisai Trial Site #1
City
Seongnamsi Bundang
State/Province
Gyeonggi-Do
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Eisai Trial Site #5
City
Jongno-gu
State/Province
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Eisai Trial Site #2
City
Seodaemun
State/Province
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Eisai Trial Site #4
City
Songpa-gu
State/Province
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Eisai Trial Site #3
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Chang Gung Medical Foundation - Kaohsiung Branch
City
Kao-Hsiung
Country
Taiwan
Individual Site Status
Not yet recruiting
Facility Name
Taichung Veterans General Hospital
City
Taichung
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
National Cheng Kung University Hospital
City
Tainan
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Taipei Veterans General Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Chang Gung Medical Foundation - Linkou Branch
City
Taoyuan
Country
Taiwan
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

Learn more about this trial

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

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