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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04008797
Recruitment Status : Recruiting
First Posted : July 5, 2019
Last Update Posted : November 14, 2022
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.

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).

Condition or disease Intervention/treatment Phase
Neoplasms Carcinoma, Hepatocellular Liver Neoplasms Colorectal Neoplasms Endometrial Neoplasms Drug: E7386 Drug: Lenvatinib Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 181 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Phase 1b Study of E7386 in Combination With Other Anticancer Drug in Subjects With Solid Tumor
Actual Study Start Date : July 11, 2019
Estimated Primary Completion Date : June 30, 2024
Estimated Study Completion Date : June 30, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Lenvatinib

Arm Intervention/treatment
Experimental: Dose Escalation Part: HCC: E7386 QD Subpart + Lenvatinib
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 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.
Drug: E7386
E7386, tablets, orally.

Drug: Lenvatinib
Lenvatinib, capsules, orally.
Other Names:
  • Lenvima
  • E7080

Experimental: Dose Escalation Part: HCC: E7386 BID Subpart + Lenvatinib
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.
Drug: E7386
E7386, tablets, orally.

Drug: Lenvatinib
Lenvatinib, capsules, orally.
Other Names:
  • Lenvima
  • E7080

Experimental: Dose Escalation Part: Other ST: E7386 QD Subpart + Lenvatinib
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.
Drug: E7386
E7386, tablets, orally.

Drug: Lenvatinib
Lenvatinib, capsules, orally.
Other Names:
  • Lenvima
  • E7080

Experimental: Dose Escalation Part: Other ST: E7386 BID Subpart + Lenvatinib
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.
Drug: E7386
E7386, tablets, orally.

Drug: Lenvatinib
Lenvatinib, capsules, orally.
Other Names:
  • Lenvima
  • E7080

Experimental: 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.
Drug: Lenvatinib
Lenvatinib, capsules, orally.
Other Names:
  • Lenvima
  • E7080

Experimental: 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 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.
Drug: E7386
E7386, tablets, orally.

Drug: Lenvatinib
Lenvatinib, capsules, orally.
Other Names:
  • Lenvima
  • E7080

Experimental: Dose Expansion Part: CRC Subpart: E7386 + Lenvatinib
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.
Drug: E7386
E7386, tablets, orally.

Drug: Lenvatinib
Lenvatinib, capsules, orally.
Other Names:
  • Lenvima
  • E7080

Experimental: Dose Expansion Part: EC Subpart: E7386 + Lenvatinib
Participants with endometrial cancer (EC) 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.
Drug: E7386
E7386, tablets, orally.

Drug: Lenvatinib
Lenvatinib, capsules, orally.
Other Names:
  • Lenvima
  • E7080




Primary Outcome Measures :
  1. Dose Escalation Part: Number of Participants with Dose-limiting Toxicities (DLTs) [ Time Frame: Cycle 0 (Cycle 0 length=6 or 7 days) up to Cycle 1 (Cycle 1 length=28 days) ]
    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).

  2. 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 Measures :
  1. Dose Escalation Part: Cmax: Maximum Observed Plasma Concentration 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) ]
    Here BID is twice daily and QD is once daily.

  2. 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) ]
  3. 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) ]
  4. 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) ]
  5. 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) ]
  6. 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) ]
  7. 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) ]
  8. 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) ]
  9. 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) ]
  10. 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) ]
  11. Percentage of Participants with Best Overall Response (BOR) [ 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) ]
    BOR is defined as complete response (CR), 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.

  12. Objective Response Rate (ORR) [ 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) ]
    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.

  13. Disease Control Rate (DCR) [ 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) ]
    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.

  14. Clinical Benefit Rate (CBR) [ 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) ]
    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.

  15. Progression-free Survival (PFS) [ Time Frame: From first dose of study drug until PD, or death from any cause, whichever occurs first (up to approximately 60 months) ]
    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.

  16. Overall Survival (OS) [ Time Frame: From first dose of study drug until death from any cause (up to approximately 60 months) ]
    OS is defined as the time from the first dose of study drug to death due to any cause.

  17. Duration of Response (DOR) [ Time Frame: From first dose of study drug until PD, or death from any cause, whichever occurs first (up to approximately 60 months) ]
    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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  9. For HCC participants only: Participants categorized to stage B (not applicable for trans arterial chemoembolization), 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 adjuvant and/or 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 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 or without an anti-vascular endothelial growth factor receptor (VEGF) monoclonal antibodies (mAb) (example, bevacizumab)
    3. 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
    4. BRAF inhibitor (in combination with cetuximab ± binimetinib) for BRAF V600E mutated tumors
    5. 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 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 brain or subdural metastases are not eligible, unless they have completed local therapy and have discontinued the use of corticosteroids for this indication for at least 4 weeks before starting treatment in this study. Any signs (example, radiologic) or symptoms of brain metastases must be stable for at least 4 weeks before starting study treatment
  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
    • Fasting beta-CTX (serum) >1000 picogram per milliliter (pg/mL) (that is, 1000 nanogram per liter [ng/L])
    • 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 treated by bisphosphonate or denosumab (except for lesion treated by radiation)
    • 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. 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 only
  11. 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
  12. For EC Subpart in Expansion Part only: carcinosarcoma (malignant mixed Mullerian tumor), endometrial leiomyosarcoma, and endometrial stromal sarcomas
  13. Has preexisting >=Grade 3 gastrointestinal or non-gastrointestinal fistula
  14. Evidence of current COVID-19 infection or ongoing unrecovered active sequelae of COVID-19 infection
  15. 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
  16. Has a known psychiatric or substance abuse disorder that would interfere with the participant ability to cooperate with the requirements of the study
  17. 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
  18. Scheduled for major surgery during the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04008797


Contacts
Layout table for location contacts
Contact: Eisai Inquiry Service eisai-chiken_hotline@hhc.eisai.co.jp

Locations
Show Show 24 study locations
Sponsors and Collaborators
Eisai Inc.
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Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT04008797    
Other Study ID Numbers: E7386-J081-102
First Posted: July 5, 2019    Key Record Dates
Last Update Posted: November 14, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eisai Inc.:
Solid Tumor
Hepatocellular carcinoma
Endometrial cancer
Colorectal cancer
E7386
Lenvatinib
Additional relevant MeSH terms:
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Neoplasms
Colorectal Neoplasms
Carcinoma, Hepatocellular
Liver Neoplasms
Endometrial Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Adenocarcinoma
Liver Diseases
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Uterine Diseases
Lenvatinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action