Phase 1
Completed N=9
A Study of E7080 in Subjects With Solid Tumor
Source: ClinicalTrials.gov NCT01268293 ↗Enrolled (actual)
9
Serious AEs
11.1%
Results posted
Mar 2015
Primary outcomePrimary: Number of Participants With Dose Limiting Toxicity (DLT) — 0 Participants
Summary
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Dose Limiting Toxicity (DLT) |
— | — |
| PRIMARY Number of Participants With Adverse Events |
9 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01268293). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.