A Study of E7130 in Participants With Solid Tumors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-05

Study Completion Date

2024-12-27

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Phase 1 Study of E7090 in Subjects With Solid Tumor

NCT02275910

Tumors

COMPLETED PHASE1

A Study of E7080 in Subjects With Solid Tumor

NCT01268293

Cancer

COMPLETED PHASE1

An Open Label Phase I Dose Escalation Study of E7080 Administered to Patients With Solid Tumors

NCT00280397

Cancer: Solid Tumors

COMPLETED PHASE1

A Phase I Study of E7050 in Subjects With Solid Tumors

NCT01428141

Solid Tumor Gastric Cancer

COMPLETED PHASE1

Study of E7389 Liposomal Formulation in Participants With Solid Tumor

NCT03207672

Solid Tumor

ACTIVE_NOT_RECRUITING PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Solid Tumors

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

E7130

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

E7130

Intervention Type DRUG

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

E7130

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

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

* 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.

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No