Philadelphia,
Pennsylvania
19104
Purpose:
The study treatment period is 15 days in length and includes patients with pituitary
Cushing's disease who are candidates for surgical intervention as well as and patients who
have recurrent Cushing's post operatively.
Criteria:
Inclusion Criteria:
- Patients with pituitary Cushing's disease within the two months prior to study entry
- Patients for whom written informed consent to participate in the study has been
obtained
- Female patients of child bearing potential who have not undergone clinically
documented total hysterectomy and/or ovariectomy, or tubal ligation must agree to use
barrier contraception throughout the course of the study, and for one month after the
study has ended
Exclusion Criteria:
- Female patients who are pregnant or lactating
- Patients who have been previously treated with certain medications may be required to
be without certain medications prior to entering the study
- Poorly controlled diabetes mellitus as indicated by the presence of ketoacidosis or
HgbA1C > 10
- Patients who have congestive heart failure, unstable angina, cardiac arrhythmia or
history of acute MI less than one year prior to the study entry or clinically
significant impairment in cardiovascular function (e.g. blood pressure of
190/100mmHg or greater)
- Patients with chronic liver disease
- Patients with clotting disorders or abnormal blood counts
- History of immuno-compromise, including a positive HIV test result
- Patients with active gall bladder disease
- Patients who have participated in any clinical investigation with an investigational
drug within 1 month prior to dosing
- Patients with active malignant disease (with the exception of basal cell carcinoma or
carcinoma in situ of the cervix)