A Study of E7130 in Participants With Solid Tumors

NCT03444701 | Completed Phase 1

• 1 other identifier: E7130-J081-101
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 9

Brief Summary

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

Conditions

Solid Tumors

Keywords

Solid tumors; Squamous cell carcinoma of the head and neck; Urothelial carcinoma

Outcome Measures

Primary Outcomes (9)

• 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).

  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.

  Cycle 1 (21 days)

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

  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.

  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.

  Up to approximately 83 months

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

  Baseline; Up to approximately 83 months

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

  Baseline; Up to approximately 83 months

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

  Up to approximately 83 months

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

  Baseline; Up to approximately 83 months

Secondary Outcomes (15)

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

  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

  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

  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

  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

  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)

Study Arms (2)

E7130 (2-Week Regimen)

EXPERIMENTAL

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

E7130 (3-Week Regimen)

EXPERIMENTAL

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

Interventions

E7130 DRUG

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

E7130 (2-Week Regimen)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eisai Co., Ltd.: lead

Study Sites (9)

Eisai Trial Site 9

Nagoya, Aichi-ken, Japan

Location

Eisai Trial Site 1

Kashiwa, Chiba, Japan

Location

Eisai Trial Site 6

Kashiwa, Chiba, Japan

Location

Eisai Trial Site 8

Sapporo, Hokkaido, Japan

Location

Eisai Trial Site 4

Sendai, Miyagi, Japan

Location

Eisai Trial Site 5

Chuo-ku, Osaka, Japan

Location

Eisai Trial Site 7

Bunkyo-ku, Tokyo, Japan

Location

Eisai Trial Site 3

Chuo-ku, Tokyo, Japan

Location

Eisai Trial Site 2

Koto-ku, Tokyo, Japan

Location

Related Publications (1)

• Doi T, Matsubara N, Naito Y, Kuboki Y, Harano K, Ono M, Urasaki T, Ohmoto A, Kawanai T, Hisai T, Ikezawa H, Shiba S, Ito K, Semba T, Asano O, Takahashi S. First-in-human study of E7130 (a tumor microenvironment-ameliorating microtubule inhibitor) in patients with advanced solid tumors: Primary results of the dose-escalation part. Cancer. 2023 Aug 1;129(15):2348-2359. doi: 10.1002/cncr.34788. Epub 2023 Apr 20.

  PMID: 37080942 DERIVED

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Carcinoma, Transitional Cell

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is a Phase 1 study of E7130 in participants with solid tumors. This study will be conducted in 2 parts (Part 1 and Part 2). Part 1 will be the dose escalation portion of this study, conducted to assess dose-limiting toxicity (DLT) and to determine the maximum tolerated dose (MTD) in participants with solid tumors. The dosage and the duration of the treatment cycle in Part 2 will be determined based on the data from Part 1. Part 2 will be comprised of cohort expansions to further characterize the safety and tolerability of E7130.

Study Record Dates

• First Submitted: February 4, 2018
• First Posted: February 23, 2018
• Study Start: February 5, 2018
• Primary Completion: December 27, 2024
• Study Completion: December 27, 2024
• Last Updated: March 6, 2025

Record last verified: 2025-03

Locations

JP (9)