Cancer
Conditions
Keywords
Cancer
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
Interventions
DRUGE7080
This arm will be a dose-escalation evaluation of 9-18 subjects 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). Administration of the study drug can continue until subjects meet discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent.
Sponsors
Eisai Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Dose Limiting Toxicity (DLT) | Up to 4 weeks | — |
| Number of Participants With Adverse Events | 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). |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| E7080 E7080 was administered orally once day (QD) in the morning. The initial dose of E7080 was 20 mg QD and increased to 24 mg QD if 20 mg was confirmed to be tolerable. | 9 |
| Total | 9 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Disease progression | 7 |
| Overall Study | Subject choice | 1 |
Baseline characteristics
| Characteristic | E7080 |
|---|---|
| Age, Continuous | 43.6 Years STANDARD_DEVIATION 11.5 |
| Sex/Gender, Customized Female | 7 Participants |
| Sex/Gender, Customized Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 9 / 9 |
| serious Total, serious adverse events | 1 / 9 |
Outcome results
Primary
Number of Participants With Adverse Events
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).
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).
Population: The Safety Analysis Set consisted of subjects who had received at least 1 dose of study drug and had at least 1 postdose safety assessment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| E7080 | Number of Participants With Adverse Events | 9 Participants |
Primary
Number of Participants With Dose Limiting Toxicity (DLT)
Time frame: Up to 4 weeks
Population: Subjects with less than 75% compliance in Cycle 1 for reasons other than the toxicity of the study drug and who discontinued prior to confirmation of tolerability in Cycle 1 were excluded from the analysis of DLT. All 9 participants completed Cycle 1 (DLT monitoring period) and were included in the analysis of DLT.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| E7080 | Number of Participants With Dose Limiting Toxicity (DLT) | 0 Participants |