NCT03444701TerminatedPhase 1
A Study of E7130 in Participants With Solid Tumors
A Phase 1 Study of E7130 in Subjects With Solid Tumor
Source: ClinicalTrials.gov · Last updated 23 Oct 2026
Reason given: The trial was prematurely terminated due to the sponsor's decision.
Brief summary (registry, in English)
The primary objective of this study is to evaluate the tolerability and safety profile of E7130 in participants with solid tumors.
- Status (registry)
- Terminated
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 62 (actual)
- First submitted
- 4 Feb 2018
- Start date
- 5 Feb 2018
- Primary completion date
- 27 Dec 2024
- Lead sponsor
- Eisai Co., Ltd.
- Diseases
- Bladder cancer, Head and neck cancer
- NCT number
- NCT03444701
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Serious concomitant systemic infection requiring medical treatment (including bacterial infection and fungal infection)
- 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
- Scheduled for surgery during the study
Other illness
- Medical history of clinically significant cardiovascular impairment
- 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.
- Other active malignancy
- Any medical or other condition that in the opinion of the investigator(s) would preclude the participant's participation in the study
Lab values
- Participants whose toxicity of previous treatment has not recovered to Grade 1 or lower (except for alopecia and hemoglobin)
Other
- Effusion requiring drainage
- 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]).
- Diagnosed with meningeal carcinomatosis
- Participants with brain or subdural metastases are not eligible.
Who the study is looking for
- 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.
Age in the registry: 20 years to - · Sex: All · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - | Bunkyo-ku | Japan | Unknown status |
| - | Chuo-ku | Japan | Unknown status |
| - | Chuo-ku | Japan | Unknown status |
| - | Kashiwa | Japan | Unknown status |
| - | Kashiwa | Japan | Unknown status |
| - | Koto-ku | Japan | Unknown status |
| - | Nagoya | Japan | Unknown status |
| - | Sapporo | Japan | Unknown status |
| - | Sendai | Japan | Unknown status |
Related publications
- First-In-Human Study: Dose Expansion of E7130 in Urothelial Carcinoma and Squamous Cell Carcinoma of the Head and Neck.Cancer Sci · 2026 · PMID 42203677
This page is information, not medical advice. Discuss any trial with your doctor.