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Completed

NCT Number: NCT03444701

A Study of E7130 in Participants With Solid Tumors

The primary objective of this study is to evaluate the tolerability and safety profile of E7130 in participants with solid tumors.

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Key information

Conditions

Solid Tumors Carcinoma Carcinoma, Squamous Cell Carcinoma, Transitional Cell Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Squamous Cell Carcinoma of Head and Neck

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Eisai Trial Site 9, Nagoya, Aichi-ken, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants who have provided voluntary written consent for participation in this clinical study
  • Participants to whom the rules for complying with this clinical study have been adequately explained, and who intend to and can comply with these rules
  • Participants aged greater than or equal to (>=) 20 years at the time of informed consent
  • Participants with adequate function of major organs
  • Participants with Performance Status score of 0 to 1 established by the Eastern Cooperative Oncology Group (ECOG)
  • Participants who are expected to survive for 3 months or longer after starting administration of the investigational drug
  • Washout period required from the end of prior treatment to the first administration of study drug
  • Participants who agree to submit blood samples prior and during study treatment for progressive disease (PD) markers.

Inclusion criteria

(Part 2 only):

  • Measurable disease meeting the 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 response evaluation criteria in solid tumours (RECIST) 1.1 using computerized tomography/magnetic resonance imaging (CT/MRI).
  • Lesions that have had external beam radiotherapy (EBRT) or locoregional therapies such as radiofrequency (RF) ablation must show evidence of progressive disease to be deemed a target lesion.

Exclusion criteria

  • Medical history of clinically significant cardiovascular impairment
  • Serious concomitant systemic infection requiring medical treatment (including bacterial infection and fungal infection)
  • Participants who test positive for human immunodeficiency virus (HIV antibody)
  • Active viral hepatitis (B or C) as demonstrated by positive serology or requiring treatment hepatitis B surface antigen (HBsAg), anti-hepatitis B surface antibody (anti-HBs)/hepatitis B core antibody (HBcAb) and anti-hepatitis C virus (HCV) antibody test.
  • Effusion requiring drainage
  • Participants whose toxicity of previous treatment has not recovered to Grade 1 or lower (except for alopecia and hemoglobin)
  • Other active malignancy
  • Females who are breastfeeding or pregnant at Screening or Baseline (as documented by a positive beta-human chorionic gonadotropin [ß-hCG] or human chorionic gonadotropin [hCG]).
  • Women of childbearing potential or men of impregnate potential who don't agree that both the participant and his/her partner will use a medically effective method for contraception during the study and after study drug discontinuation (male; 90 days, female; 60 days)
  • Known intolerance to the study drug or any of the excipients
  • Any medical or other condition that in the opinion of the investigator(s) would preclude the participant's participation in the study
  • Scheduled for surgery during the study
  • Diagnosed with meningeal carcinomatosis
  • Participants with brain or subdural metastases are not eligible.

Treatment and study plan

E7130

Drug

Starting dose of 25 μg/m^2 on Day 1 and Day 15 of Cycle 1.

Primary outcomes

  1. Part 1: Number of participants assigned to the every 2 weeks regimen with dose-limiting toxicities (DLTs)

    Time frame: Cycle 1 (28 days)

    DLTs are defined as study drug related adverse events (AEs). Toxicity will be evaluated according to National Cancer Institute Common Terminology Criteria for Adverse Events version 4.03 (NCI CTCAE 4.03).

  2. Part 1: Number of participants assigned to the every 3 weeks regimen with DLTs

    Time frame: Cycle 1 (21 days)

    DLTs are defined as study drug related AEs. Toxicity will be evaluated according to NCI CTCAE 4.03.

  3. Part 1 and Part 2: Number of participants with adverse events (AEs)

    Time frame: Up to approximately 83 months

  4. Part 1 and Part 2: Number of participants with any clinically significant clinical laboratory test value

    Time frame: Up to approximately 83 months

    Clinical significance will be determined by the Investigator.

  5. Part 1 and Part 2: Number of participants with any clinically significant vital sign value

    Time frame: Up to approximately 83 months

    Clinical significance will be determined by the Investigator.

  6. Part 1 and Part 2: Change from Baseline in arterial oxygen saturation

    Time frame: Baseline; Up to approximately 83 months

  7. Part 1 and Part 2: Change from Baseline in body weight

    Time frame: Baseline; Up to approximately 83 months

  8. Part 1 and Part 2: Number of participants with any clinically significant 12-lead electrocardiogram (ECG) value

    Time frame: Up to approximately 83 months

  9. Part 1 and Part 2: Change from Baseline in the performance status (PS) score established by the Eastern Cooperative Oncology Group (ECOG)

    Time frame: Baseline; Up to approximately 83 months

Secondary outcomes

  1. Part 1: Maximum Tolerated Dose (MTD) of E7130

    Time frame: Cycle 1 and Cycle 2 (56 days [every 2 weeks regimen] [each Cycle length = 28 days], 42 days [every 3 weeks regimen] [each Cycle length = 21 days])

    The MTD will be selected as the dose with the smallest difference between the target DLT rate of 25% and an estimate of DLT rate based on the posterior distribution of DLT rate for each dose.

  2. Part 1: Maximum observed plasma concentration (Cmax) of E7130

    Time frame: Bi-weekly: Cycles 1-2 Days 1 and 15: 0-168 hours post-infusion (each Cycle length=28 days); Tri-weekly: Cycles 1-2 Day 1: 0-336 hours post-infusion (each Cycle length=21 days)

    Cmax is the maximum observed concentration of E7130 after administration of the drug.

  3. Part 1: Time to reach maximum plasma concentration (Tmax) of E7130

    Time frame: Bi-weekly: Cycles 1-2 Days 1 and 15: 0-168 hours post-infusion (each Cycle length=28 days); Tri-weekly: Cycles 1-2 Day 1: 0-336 hours post-infusion (each Cycle length=21 days)

    Tmax is the time at which the highest drug concentration occurs.

  4. Part 1: Area under the plasma concentration time curve (AUC) from time 0 to infinity

    Time frame: Bi-weekly: Cycles 1-2 Days 1 and 15: 0-168 hours post-infusion (each Cycle length=28 days); Tri-weekly: Cycles 1-2 Day 1: 0-336 hours post-infusion (each Cycle length=21 days)

  5. Part 1: Terminal elimination phase half-life (t1/2) of E7130

    Time frame: Bi-weekly: Cycles 1-2 Days 1 and 15: 0-168 hours post-infusion (each Cycle length=28 days); Tri-weekly: Cycles 1-2 Day 1: 0-336 hours post-infusion (each Cycle length=21 days)

  6. Part 1: Total clearance of E7130

    Time frame: Bi-weekly: Cycles 1-2 Days 1 and 15: 0-168 hours post-infusion (each Cycle length=28 days); Tri-weekly: Cycles 1-2 Day 1: 0-336 hours post-infusion (each Cycle length=21 days)

  7. Part 1: Volume of distribution (Vd)

    Time frame: Bi-weekly: Cycles 1-2 Days 1 and 15: 0-168 hours post-infusion (each Cycle length=28 days); Tri-weekly: Cycles 1-2 Day 1: 0-336 hours post-infusion (each Cycle length=21 days)

  8. Part 1 and Part 2: Recommended dose for future studies

    Time frame: Up to approximately 83 months

    The recommended dose will be determined based on the on the MTD, the optimal biologic dose, and efficacy/safety/pharmacokinetic/pharmacodynamic data in Part 1 and Part 2.

  9. Part 1 and Part 2: Number of participants with advanced solid tumors with anti-tumor activity

    Time frame: Up to approximately 83 months

  10. Part 1 and Part 2: Best Overall Response (BOR)

    Time frame: Up to approximately 83 months

    The BOR will be based on Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1. BOR is defined as complete response (CR), partial response (PR), stable disease (SD), progression of disease (PD), and not evaluable (NE), where SD has to be achieved at ≥5 weeks after the first dose.

  11. Part 1 and Part 2: Objective Response Rate (ORR)

    Time frame: Up to approximately 83 months

    The ORR is defined as the percentage of participants with a BOR of CR or PR.

  12. Part 1 and Part 2: Disease Control Rate (DCR)

    Time frame: Up to approximately 83 months

    DCR is defined as the percentage of participants with a BOR of CR, PR, or SD.

  13. Part 1 and Part 2: Clinical Benefit Rate (CBR)

    Time frame: Up to approximately 83 months

    The CBR is defined as the percentage of participants with a BOR of CR, PR, or durable SD (duration of SD ≥23 weeks).

  14. Part 2: Progression-free survival (PFS)

    Time frame: Up to approximately 83 months

    PFS is defined as the time from the date of the first dose to the first documented date of the event (disease progression or death from any cause, whichever occurs first).

  15. Part 2: Overall Survival (OS)

    Time frame: Up to approximately 83 months

    OS is defined as the time from the date of the first dose to the date of death from any cause.

Sponsors and collaborators

Lead sponsor

Eisai Co., Ltd.

Industry

Registry information

Official study title

A Phase 1 Study of E7130 in Subjects With Solid Tumor

Important dates

Study start
2018
Primary completion
2024
Study completion
2024
First posted
Feb 23, 2018
Registry last updated
Mar 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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