A Phase 1 Study of E7080 in Subjects With Solid Tumor
Overview
- Phase
- Phase 1
- Intervention
- E7080
- Conditions
- Cancer
- Sponsor
- Eisai Co., Ltd.
- Enrollment
- 9
- Primary Endpoint
- Number of Participants With Dose Limiting Toxicity (DLT)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief 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
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
1
Intervention: E7080
Outcomes
Primary Outcomes
Number of Participants With Dose Limiting Toxicity (DLT)
Time Frame: Up to 4 weeks
Number of Participants With Adverse Events
Time Frame: 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).
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).