Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:06 PM
Ignite Modification Date:
2025-12-24 @ 2:06 PM
NCT ID:
NCT01179295
Eligibility Criteria:
Inclusion Criteria:
* Japanese patients, who are at least 18 years of age at the first screening examination/ visit, with advanced or refractory solid tumors not amenable to standard therapy.
* Histological or cytological documentation of non-hematologic, malignant solid tumor, excluding primary brain or spinal tumors, with no current involvement in the central nervous system (CNS)
* At least one measurable lesion or evaluable disease according to response evaluation criteria in solid tumors (RECIST) version 1.1
* Eastern cooperative oncology group performance status (ECOG-PS) of 0 or 1
* Life expectancy of at least 12 weeks
Exclusion Criteria:
* Use of any anti-cancer therapy including chemotherapy, investigational agents or devices and immunotherapy within 4 weeks of the first dose of study medication
* Uncontrolled hypertension defined as systolic blood pressure \> 150 mmHg or diastolic pressure \> 90 mmHg, despite optimal medical management
* Known human immunodeficiency virus (HIV) infection or chronic active hepatitis B or C
* Inadequate bone marrow, liver and renal function
* Inability to swallow oral medications or any condition that could affect the absorption of orally administered drugs
* Concomitant treatment with cytochrome P450 isoenzymes CYP3A4 inhibitors/inducers, and CYP2C19 inhibitors/ inducers
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01179295
Study Brief:
Protocol Section:
NCT01179295