Clinical trial · Interventional
A Study of E7080 in Subjects With Solid Tumor
A Phase 1 Study of E7080 in Subjects With Solid Tumor
NCT01268293CI-TRIAL-00067410completedPhase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to investigate the tolerability and safety of E7080 up to 24 mg when administered orally on a once daily continuous dose schedule in cycles (4 weeks as 1 cycle) in subjects with solid tumors
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| E7080 | Drug | Lenvatinib | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Drug: E7080
Primary outcomes (2)
- measure
- Number of Participants With Dose Limiting Toxicity (DLT)
- timeFrame
- Up to 4 weeks
- measure
- Number of Participants With Adverse Events
- timeFrame
- Until participants met discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent or up to 19 cycles (1 cycle = 28 days).
- description
- Treatment emergent adverse events (AEs) and serious adverse events (SAEs) were evaluated by determining the AE grade according to Common Terminology Criteria for Adverse Events \[CTCAE\] version 4.0, laboratory tests, vital signs (blood pressure \[mm Hg\], heart rate \[beats per minute\], body temperature \[degree C\], and body weight \[kg\]), 12-lead electrocardiograms (ECGs; heart rate \[bpm\], QT \[msec\] and QTc \[msec\]) and Eastern Cooperative Oncology Group performance status (ECOG-PS).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria * Subjects with histologically and/or cytologically diagnosis of solid tumor * Subjects with solid tumor which is resistant to standard anti-tumor therapies, or which no appropriate treatment is available * Subjects whose toxicity of previous treatment has recovered to Grade 1 or lower toxicity (except for alopecia) * Subjects who completed previous anti-tumor therapy before at least 4 weeks * Subjects who are 20 years or older * Subjects with 0 to 1 of Performance Status * Subjects agree to be hospitalized for DLT observation * Subjects with adequate organ functions * Males and females of childbearing potential must agree to use appropriate contraception from the agreement to 30 days after study drug administration. * Agree to participate in this study in writing based on voluntary will Exclusion Criteria * Subjects with brain metastasis accompanying clinical symptoms or requiring treatment * Subjects with the severe complication or disease history * Subjects unable to take oral medication. * Subjects being treated with drugs that strongly inhibit or induce CYP3A4 and that may be possibly used during this study. * Scheduled for surgery during the projected course of the study. * Positive for human immunodeficiency virus (HIV antibody) test or positive for hepatitis B surface (HBs antigen) or hepatitis C (HCV antibody) by serum test. * Subjects who in the view of the investigator are not able to comply with this protocol because of psychiatric or physical diseases including alcoholism or drug addict * Pregnant or nursing subjects * Subjects who are participating in another clinical trial.
References
Publications (0)
Data not yet available
No reference posted for this study.