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Long Term Safety and Efficacy of Pasireotide s.c. in Patients With Cushing's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02310269
Recruitment Status : Recruiting
First Posted : December 8, 2014
Last Update Posted : November 3, 2020
Sponsor:
Information provided by (Responsible Party):
RECORDATI GROUP

Brief Summary:
This is a non-interventional, multinational, multi-center post-marketing study, to further document the safety and efficacy of pasireotide s.c. administered in routine clinical practice in patients with Cushing's disease. Patients with Cushing's disease and treated with pasireotide s.c. alone and in combination with other therapies will be monitored. For this study, each enrolled patient will be followed up for 3 years after enrollment. Patients who permanently discontinue pasireotide s.c. prior to completing the 3-year observation period will be followed up for 3 months after the last dose of pasireotide s.c.

Condition or disease Intervention/treatment
Cushings Disease Drug: SOM230

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Non-interventional Study for the Generation of Long Term Safety and Efficacy Data of Pasireotide s.c. in Patients With Cushing's Disease (Post-Authorization Safety Study)
Actual Study Start Date : March 28, 2013
Estimated Primary Completion Date : September 27, 2023
Estimated Study Completion Date : May 1, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Pasireotide

Group/Cohort Intervention/treatment
Pasireotide Drug: SOM230



Primary Outcome Measures :
  1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability profile of pasireotide s.c. [ Time Frame: 3-year follow-up ]
    Number of pasireotide s.c related adverse events and serious adverse events, when administered as monotherapy or in combination with other therapies in patients with Cushing's disease


Secondary Outcome Measures :
  1. The proportion of patients that reach mean UFC ≤ ULN as short and long-term efficacy measure [ Time Frame: At 1, 3, 6, 12, 24 and 36 months after enrolling into the study ]
    The proportion of patients with a mean UFC ≤ ULN at 1, 3, 6, 12, 24 and 36 months after enrolling into the study

  2. Changes of mean UFC measures of disease activity [ Time Frame: 3-year follow-up ]
    The absolute and percentage change from baseline of mean UFC measures of disease activity after enrolling into the study.

  3. Proportion of patients achieving serum cortisol Normalization of disease activity [ Time Frame: 3-year follow-up ]
    Proportion of patients achieving serum cortisol Normalization of disease activity where normalization refers to being within the upper and lower limit of normal ranges

  4. The absolute and percentage change of blood pressure from baseline [ Time Frame: 3-year follow-up ]
    The absolute and percentage change of blood pressure from baseline after enrolling into the study

  5. The proportion of patients with favorable shift of blood pressure from baseline [ Time Frame: 3-year follow-up ]
    The proportion of patients with favorable shift of blood pressure from baseline after enrolling into the study

  6. Changes in safety and efficacy parameters over a period of 3 months [ Time Frame: 3 months after patient's discontinuation ]
    Safety parameters include: Adverse events , Serious Adverse Events, vital signs, blood pressure, heart rate, body temperature, blood glucose (fasting plasma glucose, HemoglobinA1c), hormones (IGF-1, GH, TSH/free T4), liver enzymes (AST, ALT, alkaline phosphatase, γGT, total bilirubin), hematology, electrolytes, immunological events (e.g., allergic reactions: rash, pruritus, injection site reactions), gallbladder ultrasound and ECGs. Efficacy parameters include: Urinary Free Cortisol, serum cortisol, serum cortisol after dexamethasone testing, salivary cortisol, plasma ACTH, fasting serum lipid profile, Blood pressure, body weight, body mass index, waist circumference, tumor size and quality of life.

  7. The absolute and percentage change in tumor size [ Time Frame: 3-year follow-up ]
    The absolute and percentage change in tumor size after enrolling into the study

  8. The absolute and percentage change from baseline in patient-reported outcome questionnaires [ Time Frame: 3-year follow-up ]
    The absolute and percentage change from baseline in patient -reported outcome questionnaires (Cushing QoL and EURO QoL) after enrolling into the study

  9. Change of serum cortisol measures of disease activity [ Time Frame: 3-year follow-up ]
    The absolute and percentage change from baseline of serum cortisol measures of disease activity after enrolling into the study

  10. Change of serum cortisol after dexamathasone testing measures of disease activity [ Time Frame: 3-year followup ]
    The absolute and percentage change from baseline of serum cortisol after dexamathasone testing measures of disease activity after enrolling into the study

  11. Changes of salivary cortisol measures of disease activity [ Time Frame: 3-year follow-up ]
    The absolute and percentage change from baseline of salivary cortisol measures of disease activity after enrolling into the study

  12. Changes of ACTH measures of disease activtity [ Time Frame: 3-year follow-up ]
    The absolute and percentage change from baseline of ACTH measures of disease activity after enrolling into the study

  13. Proportion of patients achieving serum cortisol after dexamethasone testing Normalization of disease activity [ Time Frame: 3-year follow-up ]
    Proportion of patients achieving serum cortisol after dexamethasone testing Normalization of disease activity where normalization refers to being within the upper and lower limit of normal ranges

  14. Proportion of patients achieving salivary cortisol Normalization of disease activity [ Time Frame: 3-year follow-up ]
    Proportion of patients achieving salivary cortisol of disease activity where normalization refers to being within the upper and lower limit of normal ranges

  15. Proportion of patients achieving ACTH Normalization of disease activity [ Time Frame: 3-year follow-up ]
    Proportion of patients achieving ACTH of disease activity where normalization refers to being within the upper and lower limit of normal ranges

  16. Changes of fasting serum lipid profile measures of disease activtity [ Time Frame: 3-year follow-up ]
    The absolute and percentage change from baseline of fasting serum lipid profile measures of disease activity after enrolling into the study

  17. The absolute and percentage change of body weight from baseline [ Time Frame: 3-year follow-up ]
    The absolute and percentage change of body weight from baseline after enrolling into the study

  18. The absolute and percentage change of body mass index from baseline [ Time Frame: 3-year follow-up ]
    The absolute and percentage change of body mass index from baseline after enrolling into the study

  19. The absolute and percentage change of waist circumference from baseline [ Time Frame: 3-year follow-up ]
    The absolute and percentage change of waist circumference from baseline after enrolling into the study

  20. The proportion of patients with favorable shift of body weight from baseline [ Time Frame: 3-year follow-up ]
    The proportion of patients with favorable shift of body weight from baseline after enrolling into the study

  21. The proportion of patients with favorable shift of body mass index from baseline [ Time Frame: 3-year follow-up ]
    The proportion of patients with favorable shift of body mass index from baseline after enrolling into the study

  22. The proportion of patients with favorable shift of waist circumference from baseline [ Time Frame: 3-year follow-up ]
    The proportion of patients with favorable shift of waist circumference from baseline after enrolling into the study



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The patient population will consist of male and female patients aged 18 years or older with a diagnosis of Cushing's disease for whom surgery has failed or for whom surgery is not an option and who are treated with pasireotide s.c.
Criteria

Inclusion Criteria:

  • Male or female patients aged 18 years or older with a diagnosis of Cushing's disease for whom surgery has failed or for whom surgery is not an option
  • Patients must be treated with pasireotide s.c. started either at the first visit for this study or prior to study entry

Exclusion Criteria:

  • Patients with ectopic ACTH-dependent Cushing's syndrome
  • Patients with adrenal Cushing's syndrome
  • Patients with Pseudo Cushing's syndrome

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02310269


Contacts
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Contact: Recordati +390248787122
Contact: Recordati +41612056100

Locations
Hide Hide 71 study locations
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United States, Arizona
St Josephs Hospital and Medical Center Completed
Phoenix, Arizona, United States, 85013
United States, California
University of Southern California CSOM230B2410 - SC Completed
Los Angeles, California, United States, 90033
United States, Florida
Diabetes Research Institute SC Withdrawn
Miami, Florida, United States, 22136
United States, Maryland
LifeBridge Heath Cardiovascular Institute, Sinai Hospital SC - SOM230B2410 Withdrawn
Baltimore, Maryland, United States, 21215
United States, Massachusetts
Massachusetts General Hospital SC - SOM230B2410 Completed
Boston, Massachusetts, United States, 02114
United States, Ohio
Ohio State University SC - SOM230B2410 Completed
Columbus, Ohio, United States, 43210
United States, Oregon
Endocrinology Services Completed
Bend, Oregon, United States, 97702
United States, Pennsylvania
Allegheny Endocrinology Associates Recruiting
Pittsburgh, Pennsylvania, United States, 15212
Contact: Kellie Spiller    412-359-5143    kspiller@aghendo.com   
Principal Investigator: Murray B Gordon         
United States, Rhode Island
R. I. Hospital Medical Oncology Clinical Research SC Withdrawn
Providence, Rhode Island, United States, 02903
United States, Washington
Swedish Medical Center Dept.ofSeattle Neuroscience(2) Completed
Seattle, Washington, United States, 98122-4379
Canada, Quebec
Recordati Investigative Site Completed
Montreal, Quebec, Canada, H2W 1T8
Recordati Investigative Site Completed
Sherbrooke, Quebec, Canada, J1H 5N4
Canada
Recordati Investigative Site Completed
Quebec, Canada, G1V 4G2
Colombia
Recordati Investigative Site Completed
Cali, Colombia
France
Recordati Investigative Site Completed
Amiens Cedex 1, France, 80054
Recordati Investigative Site Completed
Bron Cedex, France, 69677
Recordati Investigative Site Withdrawn
Dijon, France, 21000
Recordati Investigative Site Completed
Lille Cedex, France, 59037
Recordati Investigative Site Completed
Marseille, France, 13385
Recordati Investigative Site Completed
Montpellier Cedex 5, France, 34295
Recordati Investigative Site Completed
Paris, France, 75014
Recordati Investigative Site Completed
Reims, France, 51092
Recordati Investigative Site Completed
Saint Mande, France, 94160
Recordati Investigative Site Completed
St Priest en Jarez Cedex, France, 42277
Recordati Investigative Site Withdrawn
Strasbourg, France, 67098
Germany
Recordati Investigative Site Withdrawn
Mannheim, Baden-Wuerttemberg, Germany, 68305
Recordati Investigative Site Completed
Aachen, Germany, 52074
Recordati Investigative Site Withdrawn
Berlin, Germany, 10117
Recordati Investigative Site Completed
Berlin, Germany, 13353
Recordati Investigative Site Completed
Duesseldorf, Germany, 40225
Recordati Investigative Site Completed
Erlangen, Germany, 91054
Recordati Investigative Site Completed
Essen, Germany, 45147
Recordati Investigative Site Withdrawn
Frankfurt, Germany, 60590
Recordati Investigative Site Withdrawn
Frankfurt, Germany, 60596
Recordati Investigative Site Completed
Freiburg, Germany, 79106
Recordati Investigative Site Completed
Halle, Germany, 06108
Recordati Investigative Site Completed
Hamburg, Germany, 20246
Recordati Investigative Site Withdrawn
Hamburg, Germany, 22587
Recordati Investigative Site Withdrawn
Hannover, Germany, 30159
Recordati Investigative Site Withdrawn
Hannover, Germany, 30625
Recordati Investigative Site Completed
Leipzig, Germany, 04103
Recordati Investigative Site Completed
Magdeburg, Germany, 39120
Recordati Investigative Site Withdrawn
Marburg, Germany, 35039
Recordati Investigative Site Completed
Muenchen, Germany, 81377
Recordati Investigative Site Completed
Muenchen, Germany, 81667
Recordati Investigative Site Withdrawn
Muenster, Germany, 48149
Recordati Investigative Site Completed
Oldenburg, Germany, 26122
Recordati Investigative Site Completed
Wuerzburg, Germany, 97080
Israel
Recordati Investigative Site Completed
Petach Tikva, Israel, 49100
Recordati Investigative Site Completed
Tel Aviv, Israel, 6423906
Italy
Recordati Investigative Site Completed
Ancona, AN, Italy, 60126
Recordati Investigative Site Recruiting
Messina, ME, Italy, 98125
Recordati Investigative Site Recruiting
Milano, MI, Italy, 20122
Recordati Investigative Site Completed
Milano, MI, Italy, 20149
Recordati Investigative Site Completed
Palermo, PA, Italy, 90127
Recordati Investigative Site Recruiting
Padova, PD, Italy, 35128
Recordati Investigative Site Recruiting
Pisa, PI, Italy, 56124
Recordati Investigative Site Completed
Torino, TO, Italy, 10126
Recordati Investigative Site Completed
Napoli, Italy, 80131
Recordati Investigative Site Recruiting
Padova, Italy, 35128
Lebanon
Recordati Investigative Site Completed
El Achrafiyé, Lebanon, 166830
Netherlands
Recordati Investigative Site Completed
Maastricht, AZ, Netherlands, 5800
Recordati Investigative Site Completed
Nijmegen, Netherlands, 6500 HB
Romania
Recordati Investigative Site Recruiting
Brasov, Romania
Recordati Investigative Site Completed
Bucuresti, Romania, 011863
Recordati Investigative Site Completed
Cluj, Romania, 400006
Recordati Investigative Site Completed
Târgu-Mureş, Romania, 540061
Sweden
Recordati Investigative Site Withdrawn
Gothenburg, Sweden, SE-413 45
Recordati Investigative Site Withdrawn
Uppsala, Sweden, SE-751 85
United Kingdom
Recordati Investigative Site Completed
Plymouth, United Kingdom, PL6 8DH
Recordati Investigative Site Withdrawn
Southampton, United Kingdom, SO16 6YD
Sponsors and Collaborators
RECORDATI GROUP
Investigators
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Study Director: Recordati Recordati Rare Diseases
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: RECORDATI GROUP
ClinicalTrials.gov Identifier: NCT02310269    
Other Study ID Numbers: CSOM230B2410
First Posted: December 8, 2014    Key Record Dates
Last Update Posted: November 3, 2020
Last Verified: September 2020
Keywords provided by RECORDATI GROUP:
Cushing's disease,
pasireotide s.c.
Signifor
Additional relevant MeSH terms:
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ACTH-Secreting Pituitary Adenoma
Pituitary ACTH Hypersecretion
Hyperpituitarism
Pituitary Diseases
Hypothalamic Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Endocrine System Diseases
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pituitary Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Pasireotide
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs