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:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-25 @ 1:23 AM
NCT ID:
NCT02054793
Eligibility Criteria:
Inclusion Criteria:
* \> 18 years of age
* must provide written consent
* must agree to use contraception
* has a diagnosis of castrate resistant prostate cancer
* normal clinical lab values ALT and AST must be ≤ 2.5 x the upper limit of normal (ULN). Total bilirubin must be ≤ 1.5 x ULN. Estimated creatinine clearance using the Cockcroft-Gault formula must be \> 40 mL/minute Absolute neutrophil count (ANC) must be ≥ 1500/uL Platelet count must be ≥ 100,000/uL
* has stable medical conditions (including absence of acute exacerbations of chronic illnesses, serious infections or major surgery within 4 weeks before first dose of drug
* castrate level of testosterone (\< 50ng/dL)
* screening calculated ejection fraction of \> 50% by ECHO.
Exclusion Criteria:
* received prior therapy with orteronel, ketoconazole, aminoglutethimide, or abiraterone. Prior enzalutamide treatment is permitted.
* prior use of docetaxel for CRPC
* symptomatic metastatic disease with signs of rapid progression per investigator's clinical judgment or hepatic metastases
* currently receiving corticosteroids
* concurrent use of acid-lowering drugs (histamine antagonists, proton pump inhibitors)
* known hypersensitivity to compounds related to orteronel, orteronel excipients, itraconazole or related compounds including other azole antifungals
* concurrent administration of other drugs that significantly interact with CYP450 3A4 isoenzyme
* known brain metastases
* treatment with any investigational products within one month before the first dose of study drug
* diagnosis of or treatment for another systemic malignancy within 2 years before the first dose of study drug, or previously diagnosed with another malignancy and have any evidence of residual disease
* history of myocardial infarction, unstable symptomatic ischemic heart disease, ongoing arrhythmias of Grade \>2 (NCI CTCAE version 4.0, effective dates 14 June 2010), thromboembolic events (e.g. deep vein thrombosis, pulmonary embolism, or symptomatic cerebrovascular events), or any other cardiac condition (e.g. pericardial effusion, restrictive
* has New York Heart Association (NYHA) Class III or IV heart failure
* uncontrolled hypertension despite appropriate medical therapy (systolic blood pressure \>160 mm Hg or diastolic blood pressure \>90 mmHg) at 2 separate measurements no more than 60 minutes apart during the Screening visit).
* has known gastrointestinal (GI) disease or GI procedure that could interfere with the GI absorption or tolerance of orteronel, including difficulty swallowing tablets
* likely unable to comply with the protocol or cooperate fully with the investigator and site personnel
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT02054793
Study Brief:
Protocol Section:
NCT02054793