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Safety and Efficacy of Different Dose Levels of Pasireotide in Patients With de Novo, Persistent or Recurrent Cushing's Disease

Primary Purpose

Cushing's Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pasireotide
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cushing's Disease focused on measuring Cushing's Disease, pasireotide, SOM230

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Stanford University Medical Center Stanford Cancer Center (3)
  • University Chicago Hospital Dept. of Univ of Chicago
  • Dana Farber Cancer Institute The Melanoma Program
  • Columbia University Medical Center- New York Presbyterian Columbia University DeptofMed
  • Cleveland Clinic Foundation Dept. of Cleveland Clinic (6)
  • Oregon Health & Sciences University Dept.ofOregonHealth&SciencesU.
  • University of Texas Southwestern Medical Center Clinical-TranslationalRes.Ctr.
  • University of Texas/MD Anderson Cancer Center Dept.ofMDAndersonCancerCtr(8)
  • Baylor College of Medicine
  • Swedish Medical Center Dept.ofSeattle Neuroscience(2)
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Pasireotide 600 ug

Pasireotide 900 ug

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change From Baseline in mUFC
Twenty four hour urine samples were collected to obtain mUFC measurements. A negative change from baseline indicates improvement.
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.
Percent Change From Baseline in Serum Cortisol
Blood samlpes were drawn to obtain serum cortisol levels. A negative change from baseline indicates improvement.
Percent Change From Baseline in Mean Adrenocorticotropic Hormone (ACTH)
Blood samples were drawn to obtain ACTH levels. A negative change from baseline indicates improvement.
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.
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.
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.
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.
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.
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.
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.
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.
Change From Baseline in Tumor Volume
Pituitary magnetic resonance imaging (MRI) was performed to determine tumor volume. A negative change from baseline indicates imrpovement.
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.

Full Information

First Posted
February 9, 2007
Last Updated
February 5, 2016
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00434148
Brief Title
Safety and Efficacy of Different Dose Levels of Pasireotide in Patients With de Novo, Persistent or Recurrent Cushing's Disease
Official Title
A Randomized, Double-blind Study to Assess the Safety and Efficacy of Different Dose Levels of Pasireotide (SOM230) Subcutaneous (sc) Over a 6 Month Treatment Period in Patients With de Novo, Persistent or Recurrent Cushing's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cushing's Disease
Keywords
Cushing's Disease, pasireotide, SOM230

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
162 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pasireotide 600 ug
Arm Type
Experimental
Arm Description
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.
Arm Title
Pasireotide 900 ug
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Pasireotide
Primary Outcome Measure Information:
Title
Number of mUFC (Urinary Free Cortisol) Responders by Randomized Dose Group
Description
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
Secondary Outcome Measure Information:
Title
Change From Baseline in mUFC
Description
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
Title
Time to First UFC Response
Description
Time to first UFC response is defined as the number of months from baseline to first attainment of UFC response.
Time Frame
12 months
Title
Percent Change From Baseline in Serum Cortisol
Description
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
Title
Percent Change From Baseline in Mean Adrenocorticotropic Hormone (ACTH)
Description
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
Title
Mean Change From Baseline in Clinical Signs and Symptoms of Cushing's Disease: Sitting Sytolic Blood Pressure (SBP) and Sitting Diastolic Blood Pressure (DBP)
Description
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
Title
Mean Change From Baseline in Clinical Signs and Symptoms of Cushing's Disease: Body Mass Index (BMI)
Description
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
Title
Mean Change From Baseline in Clinical Signs and Symptoms of Cushing's Disease: Waist Circumference
Description
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
Title
Mean Change From Baseline in Clinical Signs and Symptoms of Cushing's Disease: Total Cholesterol and Triglycerides
Description
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
Title
Mean Change From Baseline in Clinical Signs and Symptoms of Cushing's Disease: Beck Depression Inventory (BDI-II) Score
Description
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
Title
Mean Change From Baseline in Clinical Signs and Symptoms of Cushing's Disease: Ferriman-Galway Hirsutism Score
Description
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
Title
Mean Change From Baseline in Clinical Signs and Symptoms of Cushing's Disease: Bone Mineral Density (BMD)
Description
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
Title
Mean Change From Baseline in Clinical Signs and Symptoms of Cushing's Disease: Body Composition
Description
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
Title
Change From Baseline in Tumor Volume
Description
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
Title
Percentage Change From Baseline in Health Related Quality of Life (HRQL) Score
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Stanford University Medical Center Stanford Cancer Center (3)
City
Stanford
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
University Chicago Hospital Dept. of Univ of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Dana Farber Cancer Institute The Melanoma Program
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Columbia University Medical Center- New York Presbyterian Columbia University DeptofMed
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Cleveland Clinic Foundation Dept. of Cleveland Clinic (6)
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Oregon Health & Sciences University Dept.ofOregonHealth&SciencesU.
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
University of Texas Southwestern Medical Center Clinical-TranslationalRes.Ctr.
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-8527
Country
United States
Facility Name
University of Texas/MD Anderson Cancer Center Dept.ofMDAndersonCancerCtr(8)
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Swedish Medical Center Dept.ofSeattle Neuroscience(2)
City
Seattle
State/Province
Washington
Country
United States
Facility Name
Novartis Investigative Site
City
Capital Federal
State/Province
Buenos Aires
ZIP/Postal Code
1425EKP
Country
Argentina
Facility Name
Novartis Investigative Site
City
Buenos Aires
ZIP/Postal Code
C1232AAC
Country
Argentina
Facility Name
Novartis Investigative Site
City
Buenos Aires
ZIP/Postal Code
C1405BCH
Country
Argentina
Facility Name
Novartis Investigative Site
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
Novartis Investigative Site
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Novartis Investigative Site
City
Curitiba
State/Province
PR
ZIP/Postal Code
80060-900
Country
Brazil
Facility Name
Novartis Investigative Site
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
21941-913
Country
Brazil
Facility Name
Novartis Investigative Site
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90560-030
Country
Brazil
Facility Name
Novartis Investigative Site
City
Ribeirao Preto
State/Province
SP
ZIP/Postal Code
14048-900
Country
Brazil
Facility Name
Novartis Investigative Site
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
05403-000
Country
Brazil
Facility Name
Novartis Investigative Site
City
São Paulo
State/Province
SP
ZIP/Postal Code
01401-901
Country
Brazil
Facility Name
Novartis Investigative Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2S2
Country
Canada
Facility Name
Novartis Investigative Site
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 2Y9
Country
Canada
Facility Name
Novartis Investigative Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1T8
Country
Canada
Facility Name
Novartis Investigative Site
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Novartis Investigative Site
City
Beijing
ZIP/Postal Code
100028
Country
China
Facility Name
Novartis Investigative Site
City
Shanghai
ZIP/Postal Code
200025
Country
China
Facility Name
Novartis Investigative Site
City
Arhus
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Novartis Investigative Site
City
Copenhagen
ZIP/Postal Code
DK-2100
Country
Denmark
Facility Name
Novartis Investigative Site
City
Herlev
ZIP/Postal Code
DK-2730
Country
Denmark
Facility Name
Novartis Investigative Site
City
Helsinki
ZIP/Postal Code
FIN-00290
Country
Finland
Facility Name
Novartis Investigative Site
City
Angers
ZIP/Postal Code
49033
Country
France
Facility Name
Novartis Investigative Site
City
Grenoble Cédex 9
ZIP/Postal Code
38043
Country
France
Facility Name
Novartis Investigative Site
City
LILLE Cedex
ZIP/Postal Code
59037
Country
France
Facility Name
Novartis Investigative Site
City
Limoges cedex
ZIP/Postal Code
87042
Country
France
Facility Name
Novartis Investigative Site
City
Marseille cedex 05
ZIP/Postal Code
13385
Country
France
Facility Name
Novartis Investigative Site
City
Paris
ZIP/Postal Code
75014
Country
France
Facility Name
Novartis Investigative Site
City
Pessac Cedex
ZIP/Postal Code
33604
Country
France
Facility Name
Novartis Investigative Site
City
St Priest en Jarez Cedex
ZIP/Postal Code
42277
Country
France
Facility Name
Novartis Investigative Site
City
Toulouse Cedex 9
ZIP/Postal Code
31000
Country
France
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
10098
Country
Germany
Facility Name
Novartis Investigative Site
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Novartis Investigative Site
City
Muenchen
ZIP/Postal Code
80336
Country
Germany
Facility Name
Novartis Investigative Site
City
Würzburg
ZIP/Postal Code
97080
Country
Germany
Facility Name
Novartis Investigative Site
City
Athens
State/Province
GR
ZIP/Postal Code
105 52
Country
Greece
Facility Name
Novartis Investigative Site
City
Athens
State/Province
GR
ZIP/Postal Code
115 27
Country
Greece
Facility Name
Novartis Investigative Site
City
Haifa
ZIP/Postal Code
3339419
Country
Israel
Facility Name
Novartis Investigative Site
City
Heifa
ZIP/Postal Code
35152
Country
Israel
Facility Name
Novartis Investigative Site
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Facility Name
Novartis Investigative Site
City
Petach Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Novartis Investigative Site
City
Ancona
State/Province
AN
ZIP/Postal Code
60126
Country
Italy
Facility Name
Novartis Investigative Site
City
Cona
State/Province
FE
ZIP/Postal Code
44100
Country
Italy
Facility Name
Novartis Investigative Site
City
Milano
State/Province
MI
ZIP/Postal Code
20149
Country
Italy
Facility Name
Novartis Investigative Site
City
Milano
State/Province
MI
ZIP/Postal Code
20162
Country
Italy
Facility Name
Novartis Investigative Site
City
Padova
State/Province
PD
ZIP/Postal Code
35128
Country
Italy
Facility Name
Novartis Investigative Site
City
Pisa
State/Province
PI
ZIP/Postal Code
56124
Country
Italy
Facility Name
Novartis Investigative Site
City
Orbassano
State/Province
TO
ZIP/Postal Code
10043
Country
Italy
Facility Name
Novartis Investigative Site
City
Torino
State/Province
TO
ZIP/Postal Code
10126
Country
Italy
Facility Name
Novartis Investigative Site
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Novartis Investigative Site
City
México
State/Province
Distrito Federal
ZIP/Postal Code
06720
Country
Mexico
Facility Name
Novartis Investigative Site
City
México
State/Province
Distrito Federal
ZIP/Postal Code
14269
Country
Mexico
Facility Name
Novartis Investigative Site
City
Warszawa
ZIP/Postal Code
01 809
Country
Poland
Facility Name
Novartis Investigative Site
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Facility Name
Novartis Investigative Site
City
Sevilla
State/Province
Andalucia
ZIP/Postal Code
41013
Country
Spain
Facility Name
Novartis Investigative Site
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Facility Name
Novartis Investigative Site
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Novartis Investigative Site
City
Balcova / Izmir
ZIP/Postal Code
35340
Country
Turkey
Facility Name
Novartis Investigative Site
City
Fatih / Istanbul
ZIP/Postal Code
34098
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
31875276
Citation
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Links:
URL
http://www.novartisclinicaltrials.com//webapp/etrials/searchTrial.do
Description
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Learn more about this trial

Safety and Efficacy of Different Dose Levels of Pasireotide in Patients With de Novo, Persistent or Recurrent Cushing's Disease

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