Solid tumor
Conditions
Sponsors
Taiho Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Written consent to participate as a subject in this clinical study. -Capable of oral intake. -Histologically or cytologically confirmed to be a solid tumor. -Standard therapies are ineffective, or there is no generally accepted standard treatment. -At least 20 years of age at the time of informed consent. -Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 to 1.
Exclusion criteria
Exclusion criteria: -Unmanageable Diarrhea (e.g. watery stool, difficulty in controlling bowel movements despite the medication, grade 2 or higher, 5 stools or more per day). -Current or past severe lung disease (e.g. interstitial pneumonia, pulmonary fibrosis, or severe emphysema). -Any other active illness such as severe cardiac disease (e.g. myocardial infarction, angina pectoris, arrhythmia, or cardiac failure) that would preclude safe administration of study therapy at the time of randomization. Any of the following events within the 6 months prior to randomization: any episode of myocardial infarction or angina pectoris. QTc interval was >= 450 msec. -The diabetic patients who have poorly controlled despite the medication or severe diabetic complication. -Serious complications (e.g. serious enteritis, serious stomatitis, gastrointestinal ulceration/hemorrhage/perforation, ileus, renal failure, nephrosis syndrome, liver failure or cerebrovascular disorder).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The plasma concentrations and each pharmacokinetic parameter. Each pharmacokinetic parameter will be calculated, and be compared. | — |
Secondary
| Measure | Time frame |
|---|---|
| -Frequency of adverse events and adverse drug reactions. -Antitumor efficacy in a continuous administration period etc -Safety: Common Terminology Criteria for Adverse Events (CTCAE) -Efficacy: RECIST guideline | — |
Outcome results
None listed