A Study of E7130 in Participants With Solid Tumors

April 18, 2024 updated by: Eisai Co., Ltd.

A Phase 1 Study of E7130 in Subjects With Solid Tumor

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

95

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Japan
    • Aichi
      • Nagoya, Aichi, Japan
        • Recruiting
        • Eisai Trial Site 9
    • Chiba
      • Kashiwa, Chiba, Japan
        • Recruiting
        • Eisai Trial Site 6
      • Kashiwa, Chiba, Japan
        • Recruiting
        • Eisai Trial Site 1
    • Hokkaido
      • Sapporo, Hokkaido, Japan
        • Recruiting
        • Eisai Trial Site 8
    • Miyagi
      • Sendai, Miyagi, Japan
        • Recruiting
        • Eisai Trial Site 4
    • Osaka
      • Chuo-ku, Osaka, Japan
        • Recruiting
        • Eisai Trial Site 5
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan
        • Recruiting
        • Eisai Trial Site 7
      • Chuo-ku, Tokyo, Japan
        • Recruiting
        • Eisai Trial Site 3
      • Koto-ku, Tokyo, Japan
        • Recruiting
        • Eisai Trial Site 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 those rules
  • Participants age 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
  • 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 agree to submit blood samples prior and during study treatment for progressive disease markers.

Inclusion Criteria (Part 2 only):

  • Measurable disease meeting the following criteria:

    1. 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).

    2. Lesions that have had external beam radiotherapy (EBRT) or locoregional therapies such as radiofrequency (RF) ablation must show evidence of progressive disease based on RECIST 1.1 to be deemed a target lesion.

      Exclusion Criteria:

  • Medical history of clinically significant cardiovascular impairment
  • 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), 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)
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: E7130 (2-Week Regimen)
Part 1 (Cycle 1; 28 days): The first cohort of 3 participants will receive 25 micrograms per meters squared (μg/m^2) of E7130, on Day 1 and Day 15 as an intravenous infusion. If a drug-related Grade 2 or higher toxicity excluding clinically insignificant events is not observed in the initial cohort, dose-limiting toxicities (DLTs) will be evaluated in successive dose levels with single participants until such a toxicity is observed. Once the maximum tolerated dose (MTD) will be determined. Part 2: Participants with squamous cell carcinoma of the head and neck and urothelial carcinoma will be evaluated at the dose level determined in Part 1 in a 2-week or in a 3-week regimen based on the evaluations in Part 1.
Drug: E7130
Starting dose of 25 μg/m^2 on Day 1 and Day 15 of Cycle 1.
Drug: E7130
Starting dose is lower than one at which the first DLT was observed in the 2-week regimen administered on Day 1 of Cycle 1.
Experimental: E7130 (3-Week Regimen)
Part 1 (Cycle 1; 21 days): On Day 1, participants will receive E7130 at (-1) a lower dose than the dose at which the first DLT was observed in the 2-week regimen. Once the MTD will be determined. Part 2: Participants with squamous cell carcinoma of the head and neck and urothelial carcinoma will be evaluated at the dose level determined in Part 1 in a 3-week or in a 2-week regimen based on the evaluations in Part 1.
Drug: E7130
Starting dose of 25 μg/m^2 on Day 1 and Day 15 of Cycle 1.
Drug: E7130
Starting dose is lower than one at which the first DLT was observed in the 2-week regimen administered on Day 1 of Cycle 1.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Cycle 1 (28 days)
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.
Cycle 1 (21 days)
Part 1 and Part 2: Number of participants with adverse events (AEs)
Time Frame: Up to approximately 93 months
Up to approximately 93 months
Part 1 and Part 2: Number of participants with any clinically significant clinical laboratory test value
Time Frame: Up to approximately 93 months
Clinical significance will be determined by the Investigator.
Up to approximately 93 months
Part 1 and Part 2: Number of participants with any clinically significant vital sign value
Time Frame: Up to approximately 93 months
Clinical significance will be determined by the Investigator.
Up to approximately 93 months
Part 1 and Part 2: Change from Baseline in arterial oxygen saturation
Time Frame: Baseline; Up to approximately 93 months
Baseline; Up to approximately 93 months
Part 1 and Part 2: Change from Baseline in body weight
Time Frame: Baseline; Up to approximately 93 months
Baseline; Up to approximately 93 months
Part 1 and Part 2: Number of participants with any clinically significant 12-lead electrocardiogram (ECG) value
Time Frame: Up to approximately 93 months
Up to approximately 93 months
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 93 months
Baseline; Up to approximately 93 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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])
Part 1 and Part 2: Maximum observed plasma concentration (Cmax) of E7130
Time Frame: Bi-weekly: Cycle (C)1-2 Day (D)1, 15: 0-168 hours (h) post-infusion; C3-4 D1, 8, 15 and C5-8 Day 1: 0-end of infusion (each C=28 days); Tri-weekly: C1-2 D1: 0-336 h post-infusion, C3-C4 D1, D8, D15 and C5-8 D1 and D15: 0-end of infusion (each C=21 days)
Cmax is the maximum observed concentration of E7130 after administration of the drug.
Bi-weekly: Cycle (C)1-2 Day (D)1, 15: 0-168 hours (h) post-infusion; C3-4 D1, 8, 15 and C5-8 Day 1: 0-end of infusion (each C=28 days); Tri-weekly: C1-2 D1: 0-336 h post-infusion, C3-C4 D1, D8, D15 and C5-8 D1 and D15: 0-end of infusion (each C=21 days)
Part 1 and Part 2: Time to reach maximum plasma concentration (Tmax) of E7130
Time Frame: Bi-weekly: Cycle (C)1-2 Day (D)1, 15: 0-168 hours (h) post-infusion; C3-4 D1, 8, 15 and C5-8 Day 1: 0-end of infusion (each C=28 days); Tri-weekly: C1-2 D1: 0-336 h post-infusion, C3-C4 D1, D8, D15 and C5-8 D1 and D15: 0-end of infusion (each C=21 days)
Tmax is the time at which the highest drug concentration occurs.
Bi-weekly: Cycle (C)1-2 Day (D)1, 15: 0-168 hours (h) post-infusion; C3-4 D1, 8, 15 and C5-8 Day 1: 0-end of infusion (each C=28 days); Tri-weekly: C1-2 D1: 0-336 h post-infusion, C3-C4 D1, D8, D15 and C5-8 D1 and D15: 0-end of infusion (each C=21 days)
Part 1 and Part 2: Area under the plasma concentration time curve (AUC) from time 0 to 24 hours postdose
Time Frame: Bi-weekly: Cycle (C)1-2 Day (D)1, 15: 0-168 hours (h) post-infusion; C3-4 D1, 8, 15 and C5-8 Day 1: 0-end of infusion (each C=28 days); Tri-weekly: C1-2 D1: 0-336 h post-infusion, C3-C4 D1, D8, D15 and C5-8 D1 and D15: 0-end of infusion (each C=21 days)
Bi-weekly: Cycle (C)1-2 Day (D)1, 15: 0-168 hours (h) post-infusion; C3-4 D1, 8, 15 and C5-8 Day 1: 0-end of infusion (each C=28 days); Tri-weekly: C1-2 D1: 0-336 h post-infusion, C3-C4 D1, D8, D15 and C5-8 D1 and D15: 0-end of infusion (each C=21 days)
Part 1 and Part 2: Area under the plasma concentration time curve (AUC) from time 0 to infinity
Time Frame: Bi-weekly: Cycle (C)1-2 Day (D)1, 15: 0-168 hours (h) post-infusion; C3-4 D1, 8, 15 and C5-8 Day 1: 0-end of infusion (each C=28 days); Tri-weekly: C1-2 D1: 0-336 h post-infusion, C3-C4 D1, D8, D15 and C5-8 D1 and D15: 0-end of infusion (each C=21 days)
Bi-weekly: Cycle (C)1-2 Day (D)1, 15: 0-168 hours (h) post-infusion; C3-4 D1, 8, 15 and C5-8 Day 1: 0-end of infusion (each C=28 days); Tri-weekly: C1-2 D1: 0-336 h post-infusion, C3-C4 D1, D8, D15 and C5-8 D1 and D15: 0-end of infusion (each C=21 days)
Part 1 and Part 2: Apparent terminal elimination phase half-life (t1/2) of E7130
Time Frame: Bi-weekly: Cycle (C)1-2 Day (D)1, 15: 0-168 hours (h) post-infusion; C3-4 D1, 8, 15 and C5-8 Day 1: 0-end of infusion (each C=28 days); Tri-weekly: C1-2 D1: 0-336 h post-infusion, C3-C4 D1, D8, D15 and C5-8 D1 and D15: 0-end of infusion (each C=21 days)
Bi-weekly: Cycle (C)1-2 Day (D)1, 15: 0-168 hours (h) post-infusion; C3-4 D1, 8, 15 and C5-8 Day 1: 0-end of infusion (each C=28 days); Tri-weekly: C1-2 D1: 0-336 h post-infusion, C3-C4 D1, D8, D15 and C5-8 D1 and D15: 0-end of infusion (each C=21 days)
Part 1 and Part 2: Total clearance of E7130
Time Frame: Bi-weekly: Cycle (C)1-2 Day (D)1, 15: 0-168 hours (h) post-infusion; C3-4 D1, 8, 15 and C5-8 Day 1: 0-end of infusion (each C=28 days); Tri-weekly: C1-2 D1: 0-336 h post-infusion, C3-C4 D1, D8, D15 and C5-8 D1 and D15: 0-end of infusion (each C=21 days)
Bi-weekly: Cycle (C)1-2 Day (D)1, 15: 0-168 hours (h) post-infusion; C3-4 D1, 8, 15 and C5-8 Day 1: 0-end of infusion (each C=28 days); Tri-weekly: C1-2 D1: 0-336 h post-infusion, C3-C4 D1, D8, D15 and C5-8 D1 and D15: 0-end of infusion (each C=21 days)
Part 1 and Part 2: Apparent volume of distribution (Vd)
Time Frame: Bi-weekly: Cycle (C)1-2 Day (D)1, 15: 0-168 hours (h) post-infusion; C3-4 D1, 8, 15 and C5-8 Day 1: 0-end of infusion (each C=28 days); Tri-weekly: C1-2 D1: 0-336 h post-infusion, C3-C4 D1, D8, D15 and C5-8 D1 and D15: 0-end of infusion (each C=21 days)
Bi-weekly: Cycle (C)1-2 Day (D)1, 15: 0-168 hours (h) post-infusion; C3-4 D1, 8, 15 and C5-8 Day 1: 0-end of infusion (each C=28 days); Tri-weekly: C1-2 D1: 0-336 h post-infusion, C3-C4 D1, D8, D15 and C5-8 D1 and D15: 0-end of infusion (each C=21 days)
Part 1 and Part 2: Recommended dose for future studies
Time Frame: Up to approximately 93 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.
Up to approximately 93 months
Part 1 and Part 2: Number of participants with advanced solid tumors with anti-tumor activity
Time Frame: Up to approximately 93 months
Up to approximately 93 months
Part 1 and Part 2: Best Overall Response (BOR)
Time Frame: Up to approximately 93 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.
Up to approximately 93 months
Part 1 and Part 2: Objective Response Rate (ORR)
Time Frame: Up to approximately 93 months
The ORR is defined as the percentage of participants with a BOR of CR or PR.
Up to approximately 93 months
Part 1 and Part 2: Disease Control Rate (DCR)
Time Frame: Up to approximately 93 months
DCR is defined as the percentage of participants with a BOR of CR, PR, or SD.
Up to approximately 93 months
Part 1 and Part 2: Clinical Benefit Rate (CBR)
Time Frame: Up to approximately 93 months
The CBR is defined as the percentage of participants with a BOR of CR, PR, or durable SD (duration of SD ≥23 weeks).
Up to approximately 93 months
Part 2: Progression-free survival (PFS)
Time Frame: Up to approximately 93 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).
Up to approximately 93 months
Part 2: Overall Survival (OS)
Time Frame: Up to approximately 93 months
OS is defined as the time from the date of the first dose to the date of death from any cause.
Up to approximately 93 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eisai Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 5, 2018

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

February 4, 2018

First Submitted That Met QC Criteria

February 22, 2018

First Posted (Actual)

February 23, 2018

Study Record Updates

Last Update Posted (Actual)

April 19, 2024

Last Update Submitted That Met QC Criteria

April 18, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E7130-J081-101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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