A Study of E7130 in Participants With Solid Tumors

Eisai

Status and phase: Completed; Phase 1

Conditions: Solid Tumors

Treatments: Drug: E7130

Study type: Interventional

Funder types: Industry

Identifiers

NCT03444701

E7130-J081-101

Details and patient eligibility

About

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

Enrollment: 62 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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62 participants in 2 patient groups

E7130 (2-Week Regimen)

Experimental group

Description:

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.

Treatment:

Drug: E7130

Drug: E7130

E7130 (3-Week Regimen)

Experimental group

Description:

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.

Treatment:

Drug: E7130

Drug: E7130