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 @ 11:43 PM
Ignite Modification Date:
2025-12-24 @ 11:43 PM
NCT ID:
NCT04339751
Eligibility Criteria:
* INCLUSION CRITERIA:
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
* Adult patients (18 years and older)
* Confirmed biochemical diagnosis of Cushing s disease (primary or recurrent) as evidenced by increased 24-hour urine free cortisol (UFC), normal or increased morning plasma Adrenocorticotropic Hormone (ACTH), and pituitary origin of excess ACTH.
* Surgical candidate for resection of ACTH producing pituitary adenoma
* Enrolled in 03-N-0164, Evaluation of Neurosurgical Disorders.
* Able to provide written informed consent at the time of study enrollment.
* Participants who are physically able to become pregnant must use an effective form of birth control from 14 days prior to enrollment through 6 months following the last dose of vorinostat. Participants who are able to father a child must use an effective form of birth control from Day 0 through 3 months following the last dose of vorinostat.
EXCLUSION CRITERIA:
* Patients who have been previously treated with vorinostat.
* Patients who have received sellar radiation.
* Significant medical illnesses that in the investigator s opinion cannot be adequately controlled or would compromise the patient s ability to tolerate this vorinostat.
* Any history of cancer, unless in complete remission and off of all therapy for that disease for a minimum of 3 years.
* History of thromboembolic disorder or deep vein thrombosis
* Presence of abnormal hematological and biochemical parameters, (such as anemia or thrombocytopenia) as defined as:
* Neutrophil count \< 1.5 K//micro L
* Hemoglobin \< 8.0 g/dL.
* Hematocrit \< 0.75x LLN (lower limit of normal)
* RBC count \< 0.75x LLN
* Platelet count \< 100 x 10\^3 cells/micro L.
* Prothrombin time-international normalized ratio (PT-INR) \> 1.5x ULN or Activated partial thromboplastin time (aPTT) \> 1.5x ULN, with the exception of patients on prophylactic anticoagulation therapy
* Serum bilirubin level \> 1.5x ULN.
* Active infection being currently treated with systemic antibiotics.
* Serious concurrent medical illness including renal failure (creatinine \>3.0x - 6.0x ULN) liver failure (ALT/AST \>5.0x - 20.0x ULN) or severe cardio-respiratory disease.
* Pregnancy or lactation.
* Presence of any disease that will obscure toxicity or dangerously alter drug metabolism (such as uncontrolled diabetes or bleeding disorders)
* Currently receiving other investigational agents.
* History of allergic reactions attributed to compounds of similar chemical or biologic composition to vorinostat, such as valproate.
* Currently taking another HDACi, such as valproate.
* Currently taking coumadin or its derivative anticoagulants.
* Currently taking any other medication to reduce cortisol or ACTH levels
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04339751
Study Brief:
Protocol Section:
NCT04339751