An open-label, multi-center, expanded access study of parireotide s.c. in patients with Cushing's disease (CSOM230B2406) (SEASCAPE)
- Conditions
- Cushing's disease10021112
- Registration Number
- NL-OMON39474
- Lead Sponsor
- ovartis Pharma BV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 2
1. male or female patients aged 18 years or above
2. patients with confirmed diagnosis of Cushing's disease as evidenced by:
* Mean urninary free cortisol of three 24-hour urine samples collected during the 3-week screening period above the upper limit of the laboratory non range
* morning plasma ACTH within the normal or above normal range
* either MRI confirmation of pituitary adenoma (greater than or equal to 0.6 cm), or
inferior petrosal sinus gradient >3 after CRH stimulation (if IPSS had previously
been performed without CRH, a central to peripheral prestimulation
gradient > 2 is required. If IPSS had not previously been performed, IPSS
with CRH stimulation is required).
3. Patients with de novo Cushing*s disease must not be considered as candidates for pituitary
surgery
4. Karnofsky performance status >60
5. For patients on previous medical treatment for Cushing*s disease the following washout
periods must be completed before screening assessments are performed (see protocol section 5.2, item 6 for details).
1. Radiotherapy of the pituitary <4 weeks before screening or patient who has not recovered
from side effects
2. Patients with compression of the optic chiasm causing acute clinically significant visual
field defect
3. Patients with Cushing*s syndrome due to ectopic ACTH secretion
4. Patients with hypercortisolism secondary to adrenal tumors or nodular (primary) bilateral
adrenal hyperplasia
5. Patients who have a known inherited syndrome as the cause for hormone over secretion
6. Patients with a diagnosis of glucocorticoid-remedial aldosteronism (GRA)
7. Patients who have undergone major surgery within 1 month prior to screening
8. Patients with known gallbladder or bile duct disease, acute or chronic pancreatitis (see protocol page 26 for exceptions)
9. Diabetic patients whose blood glucose is poorly controlled as evidenced by HbA1C >8%
10. Patients who have clinically significant impairment in cardiovascular function or are at
risk thereof (see protocol for details)
11. Female patients who are pregnant or lactating, or are of childbearing potential and not
practicing a medically acceptable method of birth control.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Adverse events.</p><br>
- Secondary Outcome Measures
Name Time Method <p>• To document the efficacy of pasireotide s.c. in normalizing UFC at Week 12<br /><br>and 24,<br /><br>separately,<br /><br>• To document the efficacy of pasireotide s.c. in achieving at least 50%<br /><br>reduction of UFC from<br /><br>baseline at Week 12 and 24, separately,<br /><br>• To document the changes in clinical signs and symptoms,<br /><br>• To document the changes in patient-reported outcome questionnaires<br /><br>(CushingQoL and<br /><br>WPAI-GH),<br /><br>• To document the effects of pasireotide s.c. on the GH/IGF-I axis.</p><br>