Status:
COMPLETED
A Study of E7130 in Participants With Solid Tumors
Lead Sponsor:
Eisai Co., Ltd.
Conditions:
Solid Tumors
Eligibility:
All Genders
20+ years
Phase:
PHASE1
Brief Summary
The primary objective of this study is to evaluate the tolerability and safety profile of E7130 in participants with solid tumors.
Eligibility Criteria
Inclusion
- 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:
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
February 5 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 27 2024
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT03444701
Start Date
February 5 2018
End Date
December 27 2024
Last Update
March 6 2025
Active Locations (9)
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1
Eisai Trial Site 9
Nagoya, Aichi-ken, Japan
2
Eisai Trial Site 1
Kashiwa, Chiba, Japan
3
Eisai Trial Site 6
Kashiwa, Chiba, Japan
4
Eisai Trial Site 8
Sapporo, Hokkaido, Japan