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 @ 11:44 PM
Ignite Modification Date:
2025-12-24 @ 11:44 PM
NCT ID:
NCT02457351
Eligibility Criteria:
Inclusion Criteria:
* Male or female patients ≥ 18 years of age with histological or cytological confirmed advanced solid tumors refractory to, or not able to tolerate to any standard therapy, have no standard therapy available, or subjects must have actively refused any treatment which would be regarded standard, and / or if in the judgment of the investigator, experimental treatment is clinically and ethically acceptable.
* Adequate liver, renal and bone-marrow functions as assessed by laboratory values.
* ECOG Performance Status of 0 - 2 and life expectancy of at least 12 weeks.
* Subject with a history of hypertension should be on a stable anti-hypertensive treatment for more than 7 days prior to the first dose of study drug.
Exclusion Criteria:
Medical and surgical history:
* Previous deep vein thrombosis (within the last 6 months), arterial thrombotic events (including strokes), or pulmonary embolism.
* History of cardiac disease: congestive heart failure, angina (within past 6 months prior to study entry), myocardial infarction, or cardiac arrhythmias requiring anti-arrhythmic therapy (beta blockers or digoxin are permitted).
* Uncontrolled hypertension (systolic blood pressure \>150 mmHg or diastolic blood pressure \>90 mmHg despite optimal medical management)
* Moderate or severe hepatic impairment, i.e. Child-Pugh class B or C. History of human immunodeficiency virus (HIV) infection or chronic hepatitis B or C
* Active clinically serious infections of Common Terminology Criteria for Adverse Events (CTCAE, v. 4.03) \> Grade 2.
* Symptomatic metastatic brain or meningeal tumors unless the subject is \>3 months from definitive therapy, has no evidence of tumor growth on an imaging study within 4 weeks prior to study entry, and is clinically stable with respect to the tumor at the time of study entry.
* Seizure disorder requiring therapy (such as steroids or anti-epileptics).
* History of organ allograft.
* Use of strong inhibitors and/or inducers of CYP3A4 in the 14 days before study treatment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02457351
Study Brief:
Protocol Section:
NCT02457351