A Study of E7130 in Participants With Solid Tumors

Eisai Co., Ltd.62 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Solid Tumors

Interventions

E7130DRUG

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

E7130DRUG

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.

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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: 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 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.

Locations (9)

Eisai Trial Site 9

Nagoya, Aichi-ken, Japan

Eisai Trial Site 1

Kashiwa, Chiba, Japan

Eisai Trial Site 6

Kashiwa, Chiba, Japan

Eisai Trial Site 8

Sapporo, Hokkaido, Japan

Outcomes

Primary Outcomes

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

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).

Time frame: Cycle 1 (28 days)

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

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

Time frame: Cycle 1 (21 days)

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

Time frame: Up to approximately 83 months

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

Clinical significance will be determined by the Investigator.

Time frame: Up to approximately 83 months

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

Clinical significance will be determined by the Investigator.

Time frame: Up to approximately 83 months

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

Time frame: Baseline; Up to approximately 83 months

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

Time frame: Baseline; Up to approximately 83 months

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

Time frame: Up to approximately 83 months

Data from ClinicalTrials.gov

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Secondary Outcomes

Part 1: Maximum Tolerated Dose (MTD) of E7130

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.

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])

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

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

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)

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

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

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)

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)

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)

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)

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)

Part 1 and Part 2: Recommended dose for future studies

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.

Time frame: Up to approximately 83 months

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

Time frame: Up to approximately 83 months

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

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.

Time frame: Up to approximately 83 months

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

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

Time frame: Up to approximately 83 months

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

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

Time frame: Up to approximately 83 months

Part 1 and Part 2: 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).

Time frame: Up to approximately 83 months

Part 2: Progression-free survival (PFS)

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).

Time frame: Up to approximately 83 months

Part 2: Overall Survival (OS)

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

Time frame: Up to approximately 83 months