Phase 3
N=162
Safety and Efficacy of Different Dose Levels of Pasireotide in Patients With de Novo, Persistent or Recurrent Cushing's Disease
Cushing's Disease
Bottom Line
View on ClinicalTrials.gov: NCT00434148 ↗Enrolled (actual)
162
Serious AEs
29.6%
Results posted
Feb 2013
Primary outcome: Primary: Number of mUFC (Urinary Free Cortisol) Responders by Randomized Dose Group — 12; 21 Responders
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Pasireotide (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Mar 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of mUFC (Urinary Free Cortisol) Responders by Randomized Dose Group |
12; 21 | — |
| SECONDARY Change From Baseline in mUFC |
-375.8; -343.4; -572.6; -350.7 | — |
| SECONDARY Time to First UFC Response |
1.0; 1.0 | — |
| SECONDARY Percent Change From Baseline in Serum Cortisol |
-4.0; -10.8; -7.3; -7.7; -5.5; -7.1 | — |
| SECONDARY Percent Change From Baseline in Mean Adrenocorticotropic Hormone (ACTH) |
9.3; -15.9; -10.0; -19.1; -13.4; -10.5 | — |
| SECONDARY Mean Change From Baseline in Clinical Signs and Symptoms of Cushing's Disease: Sitting Sytolic Blood Pressure (SBP) and Sitting Diastolic Blood Pressure (DBP) |
-7.4; -9.9; -6.8; -11.4; -2.8; -9.4 | — |
| SECONDARY Mean Change From Baseline in Clinical Signs and Symptoms of Cushing's Disease: Body Mass Index (BMI) |
-1.0; -1.4; -1.2; -2.1; -2.1; -2.8 | — |
| SECONDARY Mean Change From Baseline in Clinical Signs and Symptoms of Cushing's Disease: Waist Circumference |
-1.0; -2.2; -1.9; -3.4; -4.4; -5.6 | — |
| SECONDARY Mean Change From Baseline in Clinical Signs and Symptoms of Cushing's Disease: Total Cholesterol and Triglycerides |
-0.2; -0.3; -0.4; -0.4; -0.5; -0.6 | — |
| SECONDARY Mean Change From Baseline in Clinical Signs and Symptoms of Cushing's Disease: Beck Depression Inventory (BDI-II) Score |
-4.6; -1.9; -4.6; -5.5; -4.6; -5.2 | — |
| SECONDARY Mean Change From Baseline in Clinical Signs and Symptoms of Cushing's Disease: Ferriman-Galway Hirsutism Score |
-1.3; -1.3; -0.9; -2.4; -1.3; -3.5 | — |
| SECONDARY Mean Change From Baseline in Clinical Signs and Symptoms of Cushing's Disease: Bone Mineral Density (BMD) |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Mean Change From Baseline in Clinical Signs and Symptoms of Cushing's Disease: Body Composition |
2.9; 0.3; -0.4; -0.9; -3.0; -1.6 | — |
| SECONDARY Change From Baseline in Tumor Volume |
9.3; -19.0; -8.1; -43.8; -18.1; -36.0 | — |
| SECONDARY Percentage Change From Baseline in Health Related Quality of Life (HRQL) Score |
20.7; 40.1; 19.6; 52.2; 54.9; 111.5 | — |
Summary
This study will evaluate the safety and efficacy of two different doses of Pasireotide in patients with de novo or recurrent/persistent Cushing's Disease.
Eligibility Criteria
Inclusion criteria
- 18 years or greater
- Confirmed diagnosis of ACTH-dependent Cushing's disease
- Not considered candidate for pituitary surgery
Exclusion criteria
- History of pituitary irradiation in the last 10 years
- Cushing's syndrome not caused by pituitary tumor
- Patients with active malignant disease (cancer) in the last 5 years
- Women who are pregnant or lactating
Other protocol-defined inclusion/exclusion criteria apply.
Data sourced from ClinicalTrials.gov (NCT00434148). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.