A Phase 3 interventional study of Pasireotide in Cushing's Disease, sponsored by Novartis Pharmaceuticals. Completed at 68 sites in 18 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-03-08.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Phase 3, Interventional, and Treatment
Among 37 studies in Pituitary ACTH Hypersecretion with a site in United States — 8 open to participants now, 10 under way, none of them phase 3. Pituitary ACTH Hypersecretion · United States.
Among the 37 studies in Pituitary ACTH Hypersecretion with a site in United States, this one is the 3rd largest by enrollment of the 29 interventional ones, is the only one that started in 2006, is one of 11 in phase 3, and was the 3rd registered.
64 studies on the registry are indexed under Pituitary ACTH Hypersecretion; 16 are open to participants now.
This study's enrollment of 162 is above the median of 44 across 40 interventional studies indexed under Pituitary ACTH Hypersecretion.
Browse Pituitary ACTH Hypersecretion studies →8 of the 37 studies in Pituitary ACTH Hypersecretion with a site in United States are open now, in 1 country. Each count lists the studies.
Of the 12 Pituitary ACTH Hypersecretion studies recruiting now, 7 (58%) set no upper age limit and 2 (17%) stop at 75 or younger; 6 take children under 18; 5 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →37 studies; the count open now beside each. This study's row is marked.
First in 1997; this study’s year is marked. 1 started in 2006.
Median enrollment 31 across the 29 interventional studies, 196 across the 8 observational. Of the 24 that completed or were terminated, 18 (75%) have results posted.
23 of 37 have an industry lead sponsor. The 10 most frequent:
Novartis Pharmaceuticals is the lead sponsor of 2,718 studies on the registry; 221 are open to participants now.
Of its 585 completed or terminated interventional studies of FDA-regulated products, 438 (75%) have results posted.
Novartis Pharmaceuticals has 8 studies filed under Pituitary ACTH Hypersecretion — fewer than ten, so there is no comparison to draw.
4 of the studies in Pituitary ACTH Hypersecretion with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03364803Memorial Sloan Kettering Cancer CenterCollecting Information About Treatment Results for Patients With Cushing's Syndrome | 2026-11-28 |
| NCT03604198Corcept TherapeuticsExtension Study to Evaluate the Safety of Long-Term Use of Relacorilant in Patients With Cushing Syndrome | 2026-12 |
| NCT07335315Mayo ClinicEvaluation of Intraoperative Contrast Enhanced Ultrasound for the Identification of Pituitary Adenoma in Cushing's Disease Compared to Other Pituitary Tumors | 2027-01 |
| NCT06471829H. Lundbeck A/SA Trial of Lu AG13909 in Adult Participants With Cushing's Disease | 2027-08-10 |
Among the 37 studies in Pituitary ACTH Hypersecretion with a site in United States, from their registry updates:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria
Other protocol-defined inclusion/exclusion criteria apply.
At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was \<= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 900ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotide was available commercially in their country.
Drug: Pasireotide
At randomization, participants received 900 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was \<= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 1200 ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotide was available commercially in their country.
Drug: Pasireotide
Number of mUFC (Urinary Free Cortisol) Responders by Randomized Dose Group
A responder in the primary efficacy analysis was a patient with a mUFC≤ULN at Month 6 and whose dose was not increased prior to Month 6.
Time frame: 6 months
Change From Baseline in mUFC
Twenty four hour urine samples were collected to obtain mUFC measurements. A negative change from baseline indicates improvement.
Time frame: baseline, 3 months, 12 months
Time to First UFC Response
Time to first UFC response is defined as the number of months from baseline to first attainment of UFC response.
Time frame: 12 months
Percent Change From Baseline in Serum Cortisol
Blood samlpes were drawn to obtain serum cortisol levels. A negative change from baseline indicates improvement.
Time frame: baseline, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78 months
Percent Change From Baseline in Mean Adrenocorticotropic Hormone (ACTH)
Blood samples were drawn to obtain ACTH levels. A negative change from baseline indicates improvement.
Time frame: baseline, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78 months
Mean Change From Baseline in Clinical Signs and Symptoms of Cushing's Disease: Sitting Sytolic Blood Pressure (SBP) and Sitting Diastolic Blood Pressure (DBP)
Sitting blood pressure assessments were performed at every study visit. A negative change from baseline indicates improvement.
Time frame: baseline, month 3, month 6, month 12, month 24, month 36, month 48, month 60
Mean Change From Baseline in Clinical Signs and Symptoms of Cushing's Disease: Body Mass Index (BMI)
BMI was determined by using height and weight measurements. A negative change from baseline indicates improvement.
Time frame: baseline, month 3, month 6, month 12, month 24, month 36, month 48 and month 60
Mean Change From Baseline in Clinical Signs and Symptoms of Cushing's Disease: Waist Circumference
Waist circumference was measured with a measuring tape correctly positioned. A negative change from baseline indicates improvement.
Time frame: baseline, month 3, month 6, month 12, month 24, month 36, month 48, month 60
Mean Change From Baseline in Clinical Signs and Symptoms of Cushing's Disease: Total Cholesterol and Triglycerides
Blood samples were drawn to obtain total cholesterol and triglycerides' levels. A negative change from baseline indicates improvement.
Time frame: baseline, month 3, month 6, month 12, month 24, month 36, month 48, month 60
Mean Change From Baseline in Clinical Signs and Symptoms of Cushing's Disease: Beck Depression Inventory (BDI-II) Score
The BDI-II is a 21 item self-report rating inventory measuring characteristic attitudes and symptoms of depression. The BDI-II contains 21 questions, each answer being scored on a scale value of 0 to 3. Higher total scores indicate more severe depressive symptoms. The scores range as follows: 0-13: minimal depression; 14-19: mild depression; 20-28: moderate depression; and 29-63: severe depression. A negative change from baseline indicates imrpovement.
Time frame: baseline, month 3, month 6, month 12, month 18, month 24
Mean Change From Baseline in Clinical Signs and Symptoms of Cushing's Disease: Ferriman-Galway Hirsutism Score
The Ferriman Gallwey scoring system is used to score the degree of excess male pattern body hair. The scorecard of every body location under survey begins from 0 (no excessive terminal hair growth) to 4 (extensive terminal hair growth) and the numbers are added up to a maximum count of 36. A score \>= 6 indicates the hirsutism. A negative change from baseline indicates imrpovement.
Time frame: baseline, month 3, month 6, month 12, month 24, month 36, month 48, month 60
Mean Change From Baseline in Clinical Signs and Symptoms of Cushing's Disease: Bone Mineral Density (BMD)
BMD was measured using Lunar or Hologic dual-energy X-ray absorptiometry (DXA) Instruments. Measurements were done in the lumbar vertebrae (L1-L4), proximal femur (total hip) and proximal femur (femur neck). A negative change from baseline indicates imrpovement.
Time frame: baseline, month 3, month 6, month 12, month 24, month 36, month 48, month 60
Mean Change From Baseline in Clinical Signs and Symptoms of Cushing's Disease: Body Composition
Body composition as in percentage of body fat by region was assessed by total body scan. A negative change from baseline indicates improvement.
Time frame: baseline, month 3, month 6, month 12, month 24, month 36, month 48, month 60
Change From Baseline in Tumor Volume
Pituitary magnetic resonance imaging (MRI) was performed to determine tumor volume. A negative change from baseline indicates imrpovement.
Time frame: baseline, 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78 months
Percentage Change From Baseline in Health Related Quality of Life (HRQL) Score
A Cushing's syndrome health related quality of life (HRQL) questionnaire was completed. The Cushing's Syndrome HRQL questionnaire contains 12 sentences with 5 possible answers each. The answers are based on Likert scales, with 5 response categories: Always, Often, Sometimes, Rarely and Never; or Very much, Quite a bit, Somewhat, Very little, and Not at all. The answers to each of the items are rated on a scale of 1 to 5. "1" corresponds to the response category "Always" or "Very much" and "5" corresponds to the category "Never" or "Not at all". The score is the sum of all item responses and can range from 12 to 60 points. The lower the score, the greater the Cushing's Syndrome impacts on HRQoL. A positive change from baseline indicates improvement.
Time frame: baseline, 3 months, 6 months, 12 months
The enrollment number reflects the participants who were randomized and received at least one dose of drug.
| Milestone | Pasireotide 600 ug | Pasireotide 900 ug |
|---|---|---|
| Started | 82 | 80 |
| Completed month 12 | 39 | 39 |
| Completed m. 12; did not enter extension | 13 | 7 |
| Completed month 12; entered extension | 26 | 32 |
| Completed | 13 | 7 |
| Not completed | 69 | 73 |
| Withdrew: Adverse event | 18 | 18 |
| Withdrew: Lack of efficacy | 25 | 28 |
| Withdrew: Withdrawal by subject | 15 | 15 |
| Withdrew: Protocol violation | 4 | 0 |
| Withdrew: Administrative problems | 6 | 10 |
| Withdrew: Lost to follow-up | 0 | 1 |
| Withdrew: Condition no longer requires study drug | 1 | 0 |
| Withdrew: Abnormal test procedure result | 0 | 1 |
A responder in the primary efficacy analysis was a patient with a mUFC≤ULN at Month 6 and whose dose was not increased prior to Month 6.
| Responders | Pasireotide 600 ug | Pasireotide 900 ug |
|---|---|---|
| Number of mUFC (Urinary Free Cortisol) Responders by Randomized Dose Group | 12 (7.0 to 22.3) | 21 (16.6 to 35.9) |
Twenty four hour urine samples were collected to obtain mUFC measurements. A negative change from baseline indicates improvement.
| nmol/24h | Pasireotide 600 ug | Pasireotide 900 ug |
|---|---|---|
| month 3 (n=61,62) | -375.8 ± 631.07 | -343.4 ± 485.48 |
| month 12 (n=37,35) | -572.6 ± 941.44 | -350.7 ± 380.25 |
Time to first UFC response is defined as the number of months from baseline to first attainment of UFC response.
| months | Pasireotide 600 ug | Pasireotide 900 ug |
|---|---|---|
| Time to First UFC Response | 1.0 (0.9 to 2.7) | 1.0 (0.9 to 2.7) |
Blood samlpes were drawn to obtain serum cortisol levels. A negative change from baseline indicates improvement.
| Percent change | Pasireotide 600 ug | Pasireotide 900 ug |
|---|---|---|
| month 0.5 (n=77,76) | -4.0 ± 28.23 | -10.8 ± 30.57 |
| month 1 (n=78,72) | -7.3 ± 30.13 | -7.7 ± 32.00 |
| month 1.5 (n=75,71) | -5.5 ± 27.65 | -7.1 ± 31.34 |
| month 2 (n=73,67) | -0.7 ± 35.81 | -6.4 ± 29.75 |
| month 2.5 (n=70,67) | -3.3 ± 31.40 | -10.1 ± 31.23 |
| month 3 (n=70,67) | -2.6 ± 35.79 | -10.2 ± 25.60 |
| month 4 (n=68,61) | -6.9 ± 31.88 | -10.8 ± 28.10 |
| month 5 (n=62,58) | -4.3 ± 36.96 | -10.8 ± 26.50 |
| month 6 (n=59,57) | -5.6 ± 34.28 | -9.3 ± 31.45 |
| month 7 (n=52,53) | -9.8 ± 34.44 | -5.8 ± 26.35 |
| month 8 (n=50,46) | -10.2 ± 30.85 | -9.9 ± 35.79 |
| month 9 (n=46,48) | -5.4 ± 33.49 | -5.8 ± 31.56 |
| month 10 (n=42,47) | -11.2 ± 30.25 | -9.3 ± 28.39 |
| month 11 (n=41,41) | -8.2 ± 38.19 | -14.0 ± 29.63 |
| month 12 (n=39,38) | -11.6 ± 33.75 | -15.2 ± 21.99 |
| month 15 (n=26,26) | -10.5 ± 30.14 | -12.5 ± 29.27 |
| month 18 (n=26,25) | -7.6 ± 40.35 | -17.8 ± 28.39 |
| month 21 (n=21,25) | -12.1 ± 34.23 | -15.5 ± 34.94 |
| month 24 (n=18,22) | -17.9 ± 43.46 | -18.1 ± 34.27 |
| month 27 (n=16,18) | -9.0 ± 41.71 | -12.7 ± 28.53 |
| month 30 (n=14,19) | -22.8 ± 35.43 | -22.7 ± 32.46 |
| month 33 (n=13,15) | -9.5 ± 44.64 | -25.2 ± 25.96 |
| month 36 (n=10,13) | -12.7 ± 65.43 | -13.3 ± 37.84 |
| month 39 (n=10,12) | -26.6 ± 42.89 | -25.9 ± 33.15 |
| month 42 (n=10,12) | -17.8 ± 39.54 | -18.1 ± 35.25 |
| month 45 (n=10,11) | -12.5 ± 44.89 | -8.5 ± 32.55 |
| month 48 (n=9,11) | -19.7 ± 37.88 | -20.1 ± 39.42 |
| month 51 (n=9,9) | -17.6 ± 34.60 | -24.0 ± 31.53 |
| month 54 (n=9,9) | -25.0 ± 30.49 | -6.8 ± 28.07 |
| month 57 (n=8,8) | -11.0 ± 56.61 | -30.8 ± 22.21 |
| month 60 (n=8,8) | -24.5 ± 31.89 | -18.9 ± 22.05 |
| month 63 (n=6,7) | -28.6 ± 31.20 | -24.0 ± 26.41 |
| month 66 (n=4,6) | -6.7 ± 29.29 | -22.5 ± 36.19 |
| month 69 (n=3,5) | -13.4 ± 42.68 | -33.6 ± 10.31 |
| month 72 (n=3,4) | -4.5 ± 40.94 | -22.7 ± 23.57 |
| month 75 (n=2,3) | -63.3 ± 41.13 | -23.2 ± 25.71 |
| month 78 (n=1,1) | 14.5 ± NA | -53.3 ± NA |
Blood samples were drawn to obtain ACTH levels. A negative change from baseline indicates improvement.
| percent change | Pasireotide 600 ug | Pasireotide 900 ug |
|---|---|---|
| month 0.5 (n=78,75) | 9.3 ± 181.17 | -15.9 ± 30.75 |
| month 1 (n=78,71) | -10.0 ± 37.29 | -19.1 ± 30.47 |
| month 1.5 (n=74,69) | -13.4 ± 31.64 | -10.5 ± 38.05 |
| month 2 (n=72,66) | -7.7 ± 40.86 | -13.2 ± 35.38 |
| month 2.5 (n=69,65) | -8.2 ± 37.32 | -12.0 ± 47.02 |
| month 3 (n=69,66) | -9.2 ± 40.85 | -16.3 ± 31.93 |
| month 4 (n=66,61) | -7.2 ± 38.42 | -12.8 ± 44.06 |
| month 5 (n=62,55) | -3.0 ± 42.50 | -15.0 ± 38.89 |
| month 6 (n=58,55) | -8.4 ± 43.61 | -17.3 ± 35.60 |
| month 7 (n=52,52) | -11.4 ± 45.25 | -14.6 ± 30.88 |
| month 8 (n=48,46) | -5.0 ± 51.75 | -17.0 ± 36.87 |
| month 9 (n=46,47) | -5.3 ± 55.27 | -18.2 ± 35.87 |
| month 10 (n=42,46) | -10.2 ± 48.82 | -18.2 ± 34.18 |
| month 11 (n=42,40) | -11.5 ± 44.52 | -17.4 ± 39.06 |
| month 12 (n=39,39) | -7.4 ± 53.83 | -26.5 ± 33.38 |
| month 15 (n=26,26) | -14.5 ± 43.44 | -16.3 ± 32.01 |
| month 18 (n=26,25) | -5.9 ± 57.56 | -21.2 ± 32.91 |
| month 21 (n=20,23) | -1.5 ± 51.52 | -17.3 ± 34.34 |
| month 24 (n=18,21) | -10.9 ± 47.95 | -18.0 ± 26.53 |
| month 27 (n=16,18) | -10.4 ± 53.33 | -12.5 ± 39.39 |
| month 30 (n=14,18) | -14.7 ± 56.17 | -20.0 ± 40.82 |
| month 33 (n=13,14) | -9.4 ± 55.01 | -2.4 ± 33.07 |
| month 36 (n=10,13) | 19.1 ± 112.26 | 1.2 ± 35.33 |
| month 39 (n=10,12) | -20.9 ± 48.68 | -5.3 ± 40.02 |
| month 42 (n=10,12) | -6.7 ± 59.61 | 2.7 ± 42.35 |
| month 45 (n=9,11) | 11.9 ± 89.59 | 8.1 ± 50.09 |
| month 48 (n=9,9) | -10.8 ± 65.52 | 11.7 ± 55.85 |
| month 51 (n=9,9) | 0.0 ± 65.82 | -3.1 ± 48.21 |
| month 54 (n=9,9) | 4.6 ± 77.49 | 7.3 ± 52.94 |
| month 57 (n=7,7) | 9.6 ± 59.86 | -5.0 ± 45.19 |
| month 60 (n=8,8) | 9.6 ± 61.38 | -1.3 ± 39.01 |
| month 63 (n=6,7) | 11.9 ± 73.78 | 15.4 ± 50.66 |
| month 66 (n=4,6) | 25.3 ± 75.31 | 18.3 ± 61.35 |
| month 69 (n=3,5) | 38.9 ± 78.34 | -1.2 ± 23.98 |
| month 72 (n=3,3) | 35.6 ± 78.48 | 22.0 ± 46.15 |
| month 75 (n=2,3) | -5.0 ± 77.78 | 23.1 ± 110.92 |
| month 78 (n=1,1) | 50.0 ± NA | -11.1 ± NA |
Sitting blood pressure assessments were performed at every study visit. A negative change from baseline indicates improvement.
| mmHg | Pasireotide 600 ug | Pasireotide 900 ug |
|---|---|---|
| Sitting SBP, month 3 (n=70,67) | -7.4 ± 17.37 | -9.9 ± 17.01 |
| Sitting SBP, month 6 (n=59,57) | -6.8 ± 19.35 | -11.4 ± 15.92 |
| Sitting SBP, month 12 (n=39,39) | -2.8 ± 18.40 | -9.4 ± 14.61 |
| Sitting SBP, month 24 (n=18,23) | -11.6 ± 12.82 | -11.0 ± 11.58 |
| Sitting SBP, month 36 (n=10,13) | -3.0 ± 17.08 | -11.5 ± 16.23 |
| Sitting SBP, month 48 (n=9,10) | -12.0 ± 14.15 | -3.6 ± 14.56 |
| Sitting SBP, month 60 (n=7,8) | -12.8 ± 17.10 | -2.0 ± 11.83 |
| Sitting DBP, month 3 (n=70,67) | -3.3 ± 11.01 | -4.1 ± 13.11 |
| Sitting DBP , month 6 (n=59,57) | -4.2 ± 13.54 | -5.0 ± 11.56 |
| Sitting DBP, month 12 (n=39,39) | -2.0 ± 11.65 | -5.4 ± 10.86 |
| Sitting DBP, month 24 (n=18,23) | -8.1 ± 11.35 | -6.4 ± 9.37 |
| Sitting DBP, month 36 (n=10,13) | -6.8 ± 14.17 | -7.3 ± 8.25 |
| Sitting DBP, month 48 (n=9,10) | -11.7 ± 12.02 | -1.0 ± 9.30 |
| Sitting DBP, month 60 (n=7,8) | -9.1 ± 9.79 | 0.7 ± 7.34 |
BMI was determined by using height and weight measurements. A negative change from baseline indicates improvement.
| kg/m^2 | Pasireotide 600 ug | Pasireotide 900 ug |
|---|---|---|
| month 3 (n=70,67) | -1.0 ± 1.26 | -1.4 ± 1.29 |
| month 6 (n=59,57) | -1.2 ± 1.64 | -2.1 ± 1.72 |
| month 12 (n=40,39) | -2.1 ± 2.19 | -2.8 ± 2.21 |
| month 24 (n=18,23) | -3.4 ± 2.97 | -3.0 ± 2.67 |
| month 36 (n=10,13) | -2.9 ± 2.47 | -3.3 ± 3.48 |
| month 48 (n=9,10) | -3.1 ± 2.14 | -2.4 ± 2.60 |
| month 60 (n=8,8) | -2.8 ± 1.85 | -2.0 ± 2.20 |
Waist circumference was measured with a measuring tape correctly positioned. A negative change from baseline indicates improvement.
| cm | Pasireotide 600 ug | Pasireotide 900 ug |
|---|---|---|
| month 3 (n=64,66) | -1.0 ± 10.47 | -2.2 ± 5.23 |
| month 6 (n=53,54) | -1.9 ± 8.33 | -3.4 ± 5.39 |
| month 12(n=34,35) | -4.4 ± 9.40 | -5.6 ± 7.86 |
| month 24 ( n=17,22) | -8.7 ± 9.54 | -5.1 ± 10.22 |
| month 36 (n=9,13) | -7.8 ± 10.46 | -6.4 ± 9.97 |
| month 48 (n=8,10) | -8.3 ± 11.59 | -5.1 ± 10.03 |
| month 60 (n=7,8) | -7.3 ± 12.08 | -4.6 ± 10.90 |
Blood samples were drawn to obtain total cholesterol and triglycerides' levels. A negative change from baseline indicates improvement.
| mmol/L | Pasireotide 600 ug | Pasireotide 900 ug |
|---|---|---|
| Cholesterol, month 3 (n=70,67) | -0.2 ± 1.06 | -0.3 ± 1.01 |
| Cholesterol, month 6 (n=59,55) | -0.4 ± 1.24 | -0.4 ± 0.98 |
| Cholesterol, month 12 (n=40,39) | -0.5 ± 1.29 | -0.6 ± 1.18 |
| Cholesterol, month 24 (n=18,22) | -0.6 ± 1.39 | -0.3 ± 0.81 |
| Cholesterol, month 36 (n=10,12) | -0.8 ± 1.24 | -0.1 ± 0.64 |
| Cholesterol, month 48 (n=9,10) | -0.9 ± 1.63 | -0.4 ± 0.80 |
| Cholesterol, month 60 (n=8,8) | -1.5 ± 1.57 | -0.4 ± 1.00 |
| Triglycerides, month 3 (n=70,67) | 0.1 ± 1.07 | 0.1 ± 1.01 |
| Triglycerides, month 6 (n=59,55) | 0 ± 0.92 | 0.1 ± 1.00 |
| Triglycerides, month 12 (n=40,39) | -0.1 ± 0.77 | -0.2 ± 0.69 |
| Triglycerides, month 24 (n=18,22) | 0 ± 1.05 | 0 ± 0.82 |
| Triglycerides, month 36 (n=10,12) | -0.2 ± 0.99 | 0.3 ± 1.38 |
| Triglycerides, month 48 (n=9,10) | -0.5 ± 0.94 | 0.4 ± 1.32 |
| Triglycerides, month 60 (n=8,8) | -0.7 ± 1.01 | 0.2 ± 1.02 |
The BDI-II is a 21 item self-report rating inventory measuring characteristic attitudes and symptoms of depression. The BDI-II contains 21 questions, each answer being scored on a scale value of 0 to 3. Higher total scores indicate more severe depressive symptoms. The scores range as follows: 0-13: minimal depression; 14-19: mild depression; 20-28: moderate depression; and 29-63: severe depression. A negative change from baseline indicates imrpovement.
| score on a scale | Pasireotide 600 ug | Pasireotide 900 ug |
|---|---|---|
| month 3 (n=66,65) | -4.6 ± 8.29 | -1.9 ± 9.88 |
| month 6 (n=56,55) | -4.6 ± 9.49 | -5.5 ± 8.81 |
| month 12 (n=38,37) | -4.6 ± 9.19 | -5.2 ± 9.94 |
| month 18 (n=6,6) | -1.3 ± 5.24 | -7.8 ± 5.78 |
| month 24 (n=0,1) | NA ± NA | -12.0 ± NA |
The Ferriman Gallwey scoring system is used to score the degree of excess male pattern body hair. The scorecard of every body location under survey begins from 0 (no excessive terminal hair growth) to 4 (extensive terminal hair growth) and the numbers are added up to a maximum count of 36. A score \>= 6 indicates the hirsutism. A negative change from baseline indicates imrpovement.
| score on a scale | Pasireotide 600 ug | Pasireotide 900 ug |
|---|---|---|
| month 3 (n=52,50) | -1.3 ± 3.02 | -1.3 ± 3.46 |
| month 6 (n=44,47) | -0.9 ± 2.88 | -2.4 ± 4.70 |
| month 12 (n=30,35) | -1.3 ± 1.99 | -3.5 ± 4.65 |
| month 24 (n=12,22) | -2.8 ± 2.72 | -4.0 ± 4.34 |
| month 36 (n=7,12) | -3.7 ± 2.69 | -3.2 ± 4.09 |
| month 48 (n=6,10) | -6.0 ± 3.85 | -2.5 ± 2.84 |
| month 60 (n=5,8) | -5.0 ± 3.32 | -2.9 ± 3.23 |
BMD was measured using Lunar or Hologic dual-energy X-ray absorptiometry (DXA) Instruments. Measurements were done in the lumbar vertebrae (L1-L4), proximal femur (total hip) and proximal femur (femur neck). A negative change from baseline indicates imrpovement.
| mg/cm^3 | Pasireotide 600 ug | Pasireotide 900 ug |
|---|---|---|
| Lumbar vertebrae, month 3 (n=2,2) | 0 ± 0.02 | 0 ± 0 |
| Lumbar vertebrae, month 6 (n=47,39) | 0 ± 0.06 | 0 ± 0.04 |
| Lumbar vertebrae, month 12 (n=33,29) | 0 ± 0.07 | 0 ± 0.05 |
| Lumbar vertebrae, month 24 (n=16,16) | 0 ± 0.04 | 0 ± 0.05 |
| Lumbar vertebrae, month 36 (n=8,9) | 0 ± 0.09 | 0.1 ± 0.12 |
| Lumbar vertebrae, month 48 (n=9,8) | 0 ± 0.12 | 0 ± 0.05 |
| Lumbar vertebrae, month 60 (n=7,6) | 0 ± 0.14 | 0 ± 0.08 |
| Proximal femur (total hip), month 3 (2,2) | 0 ± 0.04 | 0 ± 0.01 |
| Proximal femur (total hip), month 6 (n=46,38) | 0 ± 0.07 | 0 ± 0.05 |
| Proximal femur (total hip), month 12 (n=33,26) | 0 ± 0.04 | 0 ± 0.03 |
| Proximal femur (total hip), month 24 (n=16,13) | 0 ± 0.04 | 0 ± 0.03 |
| Proximal femur (total hip), month 36 (n=8,8) | 0 ± 0.03 | 0 ± 0.06 |
| Proximal femur (total hip), month 48 (n=8,8) | 0 ± 0.04 | 0 ± 0.05 |
| Proximal femur (total hip), month 60 (n=7,6) | -0.1 ± 0.14 | 0 ± 0.06 |
| Proximal femur (femur neck), month 3 (n=2,2) | 0 ± 0 | 0 ± 0.03 |
| Proximal femur (femur neck), month 6 (n=46,38) | 0 ± 0.03 | 0 ± 0.05 |
| Proximal femur (femur neck), month 12 (n=33,28) | 0 ± 0.04 | 0 ± 0.07 |
| Proximal femur (femur neck), month 24 (n=16,14) | 0 ± 0.05 | 0 ± 0.04 |
| Proximal femur (femur neck), month 36 (n=8,8) | 0 ± 0.02 | 0 ± 0.04 |
| Proximal femur (femur neck), month 48 (n=9,7) | 0 ± 0.05 | 0 ± 0.04 |
| Proximal femur (femur neck), month 60 (7,6) | 0 ± 0.10 | 0 ± 0.05 |
Body composition as in percentage of body fat by region was assessed by total body scan. A negative change from baseline indicates improvement.
| Percentage of body fat | Pasireotide 600 ug | Pasireotide 900 ug |
|---|---|---|
| Month 3 (n=2,2) | 2.9 ± 1.48 | 0.3 ± 0.78 |
| Month 6 (n=39,32) | -0.4 ± 3.77 | -0.9 ± 4.06 |
| Month 12 (n=29,22) | -3.0 ± 4.23 | -1.6 ± 4.27 |
| Month 24 (n=13,14) | -1.9 ± 3.24 | -1.9 ± 5.70 |
| Month 36 (n=5,8) | -2.0 ± 4.20 | -1.1 ± 4.94 |
| Month 48 (n=4,7) | -2.0 ± 5.07 | 0.1 ± 5.63 |
| Month 60 (n=4,6) | -2.8 ± 4.64 | -0.5 ± 4.97 |
Pituitary magnetic resonance imaging (MRI) was performed to determine tumor volume. A negative change from baseline indicates imrpovement.
| cm^3 | Pasireotide 600 ug | Pasireotide 900 ug |
|---|---|---|
| month 6 (n=25, 28) | 9.3 ± 44.02 | -19.0 ± 36.82 |
| month 12 (n=15, 18) | -8.1 ± 62.17 | -43.8 ± 49.47 |
| month 18 (n=8, 11) | -18.1 ± 71.62 | -36.0 ± 65.42 |
| month 24 (n=7, 13) | -27.4 ± 82.68 | -11.5 ± 66.28 |
| month 30 (n=6, 8) | -52.1 ± 55.20 | -20.9 ± 77.16 |
| month 36 (n=3, 5) | -94.1 ± 10.15 | -27.6 ± 78.86 |
| month 42 (n=3, 3) | -95.2 ± 8.40 | 84.0 ± 282.60 |
| month 48 (n=3, 3) | -20.5 ± 130.90 | 29.2 ± 164.67 |
| month 54 (n=3, 2) | -29.1 ± 107.40 | 20.3 ± 170.15 |
| month 60 (n=3, 2) | -13.5 ± 136.97 | 127.6 ± 321.88 |
| month 66 (n= 1, 1) | -100.0 ± NA | 269.8 ± NA |
| month 72 (n=1, 0) | 45.6 ± NA | NA ± NA |
| month 78 (n=1, 0) | 77.2 ± NA | NA ± NA |
A Cushing's syndrome health related quality of life (HRQL) questionnaire was completed. The Cushing's Syndrome HRQL questionnaire contains 12 sentences with 5 possible answers each. The answers are based on Likert scales, with 5 response categories: Always, Often, Sometimes, Rarely and Never; or Very much, Quite a bit, Somewhat, Very little, and Not at all. The answers to each of the items are rated on a scale of 1 to 5. "1" corresponds to the response category "Always" or "Very much" and "5" corresponds to the category "Never" or "Not at all". The score is the sum of all item responses and can range from 12 to 60 points. The lower the score, the greater the Cushing's Syndrome impacts on HRQoL. A positive change from baseline indicates improvement.
| Percentage change in HRQL score | Pasireotide 600 ug | Pasireotide 900 ug |
|---|---|---|
| month 3 (n=67,66) | 20.7 ± 60.26 | 40.1 ± 135.47 |
| month 6 (n= 55,56) | 19.6 ± 47.78 | 52.2 ± 169.47 |
| month 12 (n=20,20) | 54.9 ± 95.83 | 111.5 ± 266.75 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pasireotide 600 ug | — | 23/82 (28%) | 78/82 (95.1%) |
| Pasireotide 900 ug | — | 25/80 (31.3%) | 79/80 (98.8%) |
| Event | Pasireotide 600 ug | Pasireotide 900 ug |
|---|---|---|
| HyperglycaemiaMetabolism and nutrition disorders | 1/82 | 4/80 |
| CholelithiasisHepatobiliary disorders | 4/82 | 2/80 |
| Pituitary-dependent Cushing's syndromeEndocrine disorders | 3/82 | 3/80 |
| Diabetes mellitusMetabolism and nutrition disorders | 1/82 | 3/80 |
| Adrenal insufficiencyEndocrine disorders | 0/82 | 2/80 |
| Pituitary tumour benignNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/82 | 2/80 |
| DiarrhoeaGastrointestinal disorders | 2/82 | 0/80 |
| Cholecystitis acuteHepatobiliary disorders | 2/82 | 0/80 |
| Atrioventricular block second degreeCardiac disorders | 0/82 | 1/80 |
| Vertigo positionalEar and labyrinth disorders | 0/82 | 1/80 |
| Event | Pasireotide 600 ug | Pasireotide 900 ug |
|---|---|---|
| DiarrhoeaGastrointestinal disorders | 49/82 | 46/80 |
| NauseaGastrointestinal disorders | 40/82 | 47/80 |
| HyperglycaemiaMetabolism and nutrition disorders | 31/82 | 35/80 |
| CholelithiasisHepatobiliary disorders | 25/82 | 25/80 |
| HeadacheNervous system disorders | 25/82 | 25/80 |
| FatigueGeneral disorders | 12/82 | 24/80 |
| Abdominal painGastrointestinal disorders | 19/82 | 21/80 |
| Diabetes mellitusMetabolism and nutrition disorders | 17/82 | 18/80 |
| InsomniaPsychiatric disorders | 3/82 | 13/80 |
| AstheniaGeneral disorders | 13/82 | 6/80 |
| Age, Continuous(years) | Pasireotide 600 ug | Pasireotide 900 ug | Total |
|---|---|---|---|
| Mean | 40.5 ± 12.97 | 39.9 ± 10.77 | 40.2 ± 11.90 |
| Sex: Female, Male(Participants) | Pasireotide 600 ug | Pasireotide 900 ug | Total |
|---|---|---|---|
| Female | 62 | 64 | 126 |
| Male | 20 | 16 | 36 |
The record gives a start of Dec 2006, a primary completion of Mar 2010 and a completion of May 2014. It does not say whether these dates are actual or estimated.
Results were first posted in Feb 2013, 2 years 11 months after primary completion.
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Studies of the drug tested here: Pasireotide
Pituitary ACTH Hypersecretion →