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Trial record 31 of 74 for:    pasireotide

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

This study is currently recruiting participants.
See Contacts and Locations
Verified January 2017 by Novartis ( Novartis Pharmaceuticals )
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT02310269
First received: September 26, 2014
Last updated: January 27, 2017
Last verified: January 2017
  Purpose
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 Intervention
Cushings Disease Drug: SOM230

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • 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:
  • 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

  • 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.

  • 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

  • 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

  • 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

  • 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.

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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


Estimated Enrollment: 200
Study Start Date: March 2013
Estimated Study Completion Date: April 2024
Estimated Primary Completion Date: April 2024 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02310269

Contacts
Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals +41613241111

  Show 66 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02310269     History of Changes
Other Study ID Numbers: CSOM230B2410
Study First Received: September 26, 2014
Last Updated: January 27, 2017

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Cushing's disease,
pasireotide s.c.
Signifor

Additional relevant MeSH terms:
Pituitary ACTH Hypersecretion
ACTH-Secreting Pituitary Adenoma
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

ClinicalTrials.gov processed this record on September 20, 2017