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An Open-label, Multi-center, Expanded Access Study of Pasireotide s.c. in Patients With Cushing's Disease. (SEASCAPE)

Primary Purpose

Cushing's Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pasireotide sub-cutaneous
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, Hormone disorder, Cortisol, Adrenocorticotropic hormone, Pituitary tumor, SOM230, adult

Eligibility Criteria

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

Inclusion criteria:

  1. Written informed consent obtained prior to any screening procedures
  2. Male or female patients aged 18 years or greater
  3. Patients with confirmed diagnosis of Cushing's disease as evidenced by mean urinary free cortisol of three 24-hour urine samples collected during the 3-week screening period above the upper limit of the laboratory normal range morning plasma ACTH within the normal or above normal range either MRI confirmation of pituitary adenoma (greater than or equal to 0.6 cm), or inferior petrosal sinus gradient >3 after CRH stimulation for those patients with a microadenoma less than 0.6 cm, or for patients who have had prior pituitary surgery, histopathology confirming an ACTH staining adenoma.
  4. Patients with de novo Cushing's disease must not be considered as candidates for pituitary surgery (i.e. poor surgical candidates, surgically unapproachable tumors, patients with no visible pituitary tumor, patients who refuse to have surgical treatment)
  5. Karnofsky performance status >60 (i.e. requires occasional assistance, but is able to care for most of his personal needs)
  6. For patients on previous medical treatment for Cushing's disease the following washout periods must be completed before screening assessments are performed

    • Inhibitors of steroidogenesis (e.g. ketoconazole, metyrapone, rosiglitazone): 1 week
    • Dopamine agonists (e.g. bromocriptine, cabergoline): 4 weeks
    • Mitotane: 6 months
    • Octreotide LAR and Lanreotide autogel: 8 weeks
    • Lanreotide SR: 4 weeks
    • Octreotide (immediate release formulation): 1 week
    • Glucocorticoid receptor inhibitor (mifepristone): 4 weeks

Exclusion criteria:

  1. Radiotherapy of the pituitary <4 weeks before screening or patient who has not recovered from side effects
  2. Patients with compression of the optic chiasm causing acute clinically significant visual field defect
  3. Patients with Cushing's syndrome due to ectopic ACTH secretion
  4. Patients with hypercortisolism secondary to adrenal tumors or nodular (primary) bilateral adrenal hyperplasia
  5. Patients who have a known inherited syndrome as the cause for hormone over secretion (i.e. Carney Complex, McCune-Albright syndrome, MEN-1)
  6. Patients with a diagnosis of glucocorticoid-remedial aldosteronism (GRA)
  7. Patients who have undergone major surgery within 1 month prior to screening
  8. Patients with known gallbladder or bile duct disease, acute or chronic pancreatitis (patients with asymptomatic cholelithiasis and asymptomatic bile duct dilation can be included)
  9. Diabetic patients whose blood glucose is poorly controlled as evidenced by HbA1C >8%
  10. Patients who have clinically significant impairment in cardiovascular function or are at risk thereof, as evidenced by congestive heart failure (NYHA Class III or IV), unstable angina, sustained ventricular tachycardia, clinically significant bradycardia, high grade AV block, history of acute MI less than one year prior to study entry

    • QTcF >450 msec at screening
    • History of syncope or family history of idiopathic sudden death
    • Risk factors for Torsades de Pointes such as uncorrected hypokalemia, uncorrected hypomagnesemia, cardiac failure
    • Concomitant disease(s) that could prolong the QT interval such as autonomic neuropathy (caused by diabetes or Parkinson's disease), HIV, cirrhosis, uncontrolled hypothyroidism, concomitant medication(s) with known risk for TdP
  11. Patients with liver disease or history of liver disease such as cirrhosis, chronic active hepatitis B and C, or chronic persistent hepatitis, or patients with ALT or AST more than 2 x ULN, serum creatinine >2.0 x ULN, serum bilirubin >1.5 x ULN, serum albumin < 0.67 x LLN at screening
  12. Patients who have any current or prior medical condition that can interfere with the conduct of the study or the evaluation of its results, such as

    • History of immunocompromise, including a positive HIV test result (Elisa and Western blot). An HIV test will not be required, however, previous medical history will be reviewed
    • Presence of active or suspected acute or chronic uncontrolled infection
    • History of, or current alcohol misuse/abuse in the 12 month period prior to screening
  13. Female patients who are pregnant or lactating, or are of childbearing potential and not practicing a medically acceptable method of birth control. If a woman is participating in the trial then one form of contraception is sufficient (pill or diaphragm) and the partner should use a condom. If oral contraception is used in addition to condoms, the patient must have been practicing this method for at least two months prior to screening and must agree to continue the oral contraceptive throughout the course of the study and for one month after the study has ended. Male patients who are sexually active are required to use condoms during the study and for three month afterwards as a precautionary measure (available data do not suggest any increased reproductive risk with the study drugs)
  14. Patients who have participated in any clinical investigation with an investigational drug within 1 month prior to screening or patients who have previously been treated with pasireotide
  15. Known hypersensitivity to somatostatin analogues
  16. Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable or will be unable to complete the entire study
  17. Patients with presence of Hepatitis B surface antigen (HbsAg)
  18. Patients with presence of Hepatitis C antibody test (anti-HCV)

Sites / Locations

  • Advanced Research, LLC
  • St Josephs Hospital & Medical Center St Joes
  • University of California at Los Angeles UCLA Tiverton
  • LA Biomedical Research at Harbor UCLA Medical Center
  • Emory University School of Medicine
  • John H Stroger Jr Hospital of Cook County
  • University of Maryland Medical Center
  • Diabetes and Endocrinology Associates, PC
  • University of Nebraska Medical Center
  • University of New Mexico Hospital UNM
  • Mount Sinai School of Medicine
  • Oregon Health and Science University OHSU 5
  • University of Pennsylvania Medical Center Univ Penn
  • Allegheny Endocrinology Associates
  • Mid South Endocrine Associates
  • Vanderbilt University Medical Center
  • Swedish Cancer Institute Swedish Cancer Institute (SC)
  • 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 μg

Pasireotide 900 μg

Arm Description

Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 600 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 600 μg for glucose impaired metabolism patients. Mean daily dose category is defined on the mean daily dose considering the following grouping rule: 600 μg bid group includes all patients whose mean daily dose < 1500 μg /day.

Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 900 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 900 μg. Mean daily dose category is defined on the mean daily dose considering the following grouping rule: 900 μg bid group includes all patients whose mean daily dose ≥ 1500 μg /day

Outcomes

Primary Outcome Measures

Percentage of Patients With a Drug-related Adverse Event That is Recorded as Grade 3 or 4 or as a Serious Adverse Event (SAE)
Only AEs occurring on or after the start of study treatment and no more than 28 days after the discontinuation of study treatment. A patient with multiple occurrences of an AE under one treatment is counted only once in the AE category for that treatment. A patient with multiple severity grades for an AE while on a treatment, is only counted under the maximum grade.

Secondary Outcome Measures

Percentage of Patients With Mean Urinary Free Cortisol (UFC) ≤ Upper Limit of Normal (ULN)
The 24h-UFC concentration results from three samples during screening were averaged to obtain baseline. After baseline, mean 24h UFC was determined at week 24. At Week 4, 8, 16 and 20, mean 24h UFC was determined from two 24 hour urine collections collected on two consecutive days occurring before the visit. At Week 12, 24 and 48, the mean 24h-UFC from three 24 hour urine collections, collected over the week before the visit, was determined. After Week 24, the mean 24h UFC was determined at 12-week intervals until end of study visit, from two 24 hour collections during two consecutive days prior to each respective visit (except at Week 48). UFC was determined by liquid chromatography tandem mass spectroscopy (LC/MS/MS). The normal ranges were determined by the central laboratory's own reference range. All samples, including screening samples, were analyzed by a central laboratory.
Percentage of Patients Achieving a Reduction of Mean UFC ≥ 50% From Baseline
The 24h-UFC concentration results from three samples during screening were averaged to obtain baseline. After baseline, mean 24h UFC was determined at week 24. At Week 4, 8, 16 and 20, mean 24h UFC was determined from two 24 hour urine collections collected on two consecutive days occurring before the visit. At Week 12, 24 and 48, the mean 24h-UFC from three 24 hour urine collections, collected over the week before the visit, was determined. After Week 24, the mean 24h UFC was determined at 12-week intervals until end of study visit, from two 24 hour collections during two consecutive days prior to each respective visit (except at Week 48). UFC was determined by liquid chromatography tandem mass spectroscopy (LC/MS/MS). The normal ranges were determined by the central laboratory's own reference range. All samples, including screening samples, were analyzed by a central laboratory.
Percent Change in Cushing Quality of Life and Work Productivity and Activity Impairment-General Health (WPAI-GH) Scores
A 12-item Cushing's syndrome HRQoL questionnaire (CushingQoL, cf. Webb et al 2008) was implemented and patients who completed 9 or more items at a visit were considered evaluable for that visit. The standardized scores were calculated as follows: 1) Obtain raw scores, denoted by X, as the sum of all the ratings on all the HRQoL questions for a single patient and the score can range from 12 (worst HRQoL) to 60 points (best HRQoL). Therefore, the lower the score, greater the negative impact on HRQoL and 2) obtain standardized score, Y, for a single patient • Y = 100 (X-12) / (60-12) = 100 (X-12)/48. For example, if a patient answers all 12 items with 'Sometimes' or 'Somewhat', X = 36 and Y = 100 ∙ 24/48 = 50 The WPAI-GH questionnaire was used to assess work productivity and activity impairment. However, there was very limited baseline data and therefore the results and outcomes of the objective, 'change from baseline in WPAI-GH scores' are not included.
Percent Change in Cushing's Disease Clinical Signs and Symptoms - Blood Pressure (BP)
Standing systolic and diastolic BP based on 1 assessment and sitting systolic and diastolic BP was mean of 3 assessments.
Percent Change in Cushing's Disease Clinical Signs and Symptoms - Pulse
Change from baseline is shown as: Percent change from baseline (BL) =((Post BL value - BL value)/ BL value)*100
Percent Change in Cushing's Disease Clinical Signs and Symptoms - Temperature
degrees celius
Percent Change in Cushing's Disease Clinical Signs and Symptoms - Body Mass Index (BMI)
Percent change in patients reducing by at least one class level. Class levels: <25.0, 25.0 to <30.0, ≥ 30.0. Percent change from baseline (BL) =((Post BL value - BL value)/ BL value)*100
Percent Change in Cushing's Disease Clinical Signs and Symptoms - Weight
Clinically relevant threshold (at any time point) was reduction of ≥ 5%
Percent Change in Cushing's Disease Clinical Signs and Symptoms - Muscle Strength
Direct observation of ability to stand unaided: 0=able to stand easily with arms extended, 1=able to stand after several efforts without using arms as assistance, 2=able to stand only by using arms as assistance 3=completely unable to stand
Percent Change in Cushing's Disease Clinical Signs and Symptoms - Waist Circumference
Clinically relevant threshold (at any time point). Reduction of ≥ 5%, Reduction of ≥ 10%
Percent Change in Cushing's Disease Clinical Signs and Symptoms - Hirsutism
Change from baseline is shown as: Percent change from baseline (BL) =((Post BL value - BL value)/ BL value)*100. Ferriman-Gallway scoring was used: 0=minimum and 36 was maximum in females only.
Percent Change From Baseline in Growth Hormone (GH) Values
Descriptive summary of the effect of pasireotide on GH.
Percent Change From Baseline in Insulin Growth Factor - 1 (IGF - 1) Values
Descriptive summary of the effect of pasireotide on IGF-1

Full Information

First Posted
April 12, 2012
Last Updated
May 24, 2018
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01582061
Brief Title
An Open-label, Multi-center, Expanded Access Study of Pasireotide s.c. in Patients With Cushing's Disease.
Acronym
SEASCAPE
Official Title
An Open-label, Multi-center, Expanded Access Study of Pasireotide s.c. in Patients With Cushing's Disease (Seascape).
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
August 16, 2011 (Actual)
Primary Completion Date
January 26, 2017 (Actual)
Study Completion Date
January 26, 2017 (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 provided access to pasireotide sc in patients with Cushing's disease.and provided additional information for safety and efficacy of pasireotide s.c.
Detailed Description
Purpose of this study was to give access to pasireotide sc for patients with Cushing's disease as no medical treatment for Cushing's disease was approved at the time of the study initiation. The study population consisted of patients with persistent or recurrent Cushing's disease or patients with de novo Cushing's disease that were not considered candidates for pituitary surgery (poor surgery candidates, surgically unapproachable tumor, patients with no visible pituitary tumor, patients who refused surgery). A confirmed Cushing's disease diagnosis was required.

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, Hormone disorder, Cortisol, Adrenocorticotropic hormone, Pituitary tumor, SOM230, adult

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pasireotide 600 μg
Arm Type
Experimental
Arm Description
Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 600 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 600 μg for glucose impaired metabolism patients. Mean daily dose category is defined on the mean daily dose considering the following grouping rule: 600 μg bid group includes all patients whose mean daily dose < 1500 μg /day.
Arm Title
Pasireotide 900 μg
Arm Type
Experimental
Arm Description
Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 900 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 900 μg. Mean daily dose category is defined on the mean daily dose considering the following grouping rule: 900 μg bid group includes all patients whose mean daily dose ≥ 1500 μg /day
Intervention Type
Drug
Intervention Name(s)
Pasireotide sub-cutaneous
Other Intervention Name(s)
SOM230 sub-cutaneous
Intervention Description
Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 900 μg, 600 μg, or 300 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 900 μg and 600 μg for glucose impaired metabolism patients
Primary Outcome Measure Information:
Title
Percentage of Patients With a Drug-related Adverse Event That is Recorded as Grade 3 or 4 or as a Serious Adverse Event (SAE)
Description
Only AEs occurring on or after the start of study treatment and no more than 28 days after the discontinuation of study treatment. A patient with multiple occurrences of an AE under one treatment is counted only once in the AE category for that treatment. A patient with multiple severity grades for an AE while on a treatment, is only counted under the maximum grade.
Time Frame
Baseline up to approximately 256 weeks
Secondary Outcome Measure Information:
Title
Percentage of Patients With Mean Urinary Free Cortisol (UFC) ≤ Upper Limit of Normal (ULN)
Description
The 24h-UFC concentration results from three samples during screening were averaged to obtain baseline. After baseline, mean 24h UFC was determined at week 24. At Week 4, 8, 16 and 20, mean 24h UFC was determined from two 24 hour urine collections collected on two consecutive days occurring before the visit. At Week 12, 24 and 48, the mean 24h-UFC from three 24 hour urine collections, collected over the week before the visit, was determined. After Week 24, the mean 24h UFC was determined at 12-week intervals until end of study visit, from two 24 hour collections during two consecutive days prior to each respective visit (except at Week 48). UFC was determined by liquid chromatography tandem mass spectroscopy (LC/MS/MS). The normal ranges were determined by the central laboratory's own reference range. All samples, including screening samples, were analyzed by a central laboratory.
Time Frame
Baseline, week 12, 24 and 48
Title
Percentage of Patients Achieving a Reduction of Mean UFC ≥ 50% From Baseline
Description
The 24h-UFC concentration results from three samples during screening were averaged to obtain baseline. After baseline, mean 24h UFC was determined at week 24. At Week 4, 8, 16 and 20, mean 24h UFC was determined from two 24 hour urine collections collected on two consecutive days occurring before the visit. At Week 12, 24 and 48, the mean 24h-UFC from three 24 hour urine collections, collected over the week before the visit, was determined. After Week 24, the mean 24h UFC was determined at 12-week intervals until end of study visit, from two 24 hour collections during two consecutive days prior to each respective visit (except at Week 48). UFC was determined by liquid chromatography tandem mass spectroscopy (LC/MS/MS). The normal ranges were determined by the central laboratory's own reference range. All samples, including screening samples, were analyzed by a central laboratory.
Time Frame
Baseline, week 12, 24 and 48
Title
Percent Change in Cushing Quality of Life and Work Productivity and Activity Impairment-General Health (WPAI-GH) Scores
Description
A 12-item Cushing's syndrome HRQoL questionnaire (CushingQoL, cf. Webb et al 2008) was implemented and patients who completed 9 or more items at a visit were considered evaluable for that visit. The standardized scores were calculated as follows: 1) Obtain raw scores, denoted by X, as the sum of all the ratings on all the HRQoL questions for a single patient and the score can range from 12 (worst HRQoL) to 60 points (best HRQoL). Therefore, the lower the score, greater the negative impact on HRQoL and 2) obtain standardized score, Y, for a single patient • Y = 100 (X-12) / (60-12) = 100 (X-12)/48. For example, if a patient answers all 12 items with 'Sometimes' or 'Somewhat', X = 36 and Y = 100 ∙ 24/48 = 50 The WPAI-GH questionnaire was used to assess work productivity and activity impairment. However, there was very limited baseline data and therefore the results and outcomes of the objective, 'change from baseline in WPAI-GH scores' are not included.
Time Frame
Baseline, week 12, 24 and 48
Title
Percent Change in Cushing's Disease Clinical Signs and Symptoms - Blood Pressure (BP)
Description
Standing systolic and diastolic BP based on 1 assessment and sitting systolic and diastolic BP was mean of 3 assessments.
Time Frame
Baseline, week 12, 24 and 48
Title
Percent Change in Cushing's Disease Clinical Signs and Symptoms - Pulse
Description
Change from baseline is shown as: Percent change from baseline (BL) =((Post BL value - BL value)/ BL value)*100
Time Frame
Baseline, week 12, 24 and 48
Title
Percent Change in Cushing's Disease Clinical Signs and Symptoms - Temperature
Description
degrees celius
Time Frame
Baseline week 12, 24 and 48
Title
Percent Change in Cushing's Disease Clinical Signs and Symptoms - Body Mass Index (BMI)
Description
Percent change in patients reducing by at least one class level. Class levels: <25.0, 25.0 to <30.0, ≥ 30.0. Percent change from baseline (BL) =((Post BL value - BL value)/ BL value)*100
Time Frame
Baseline, week 12, 24 and 48
Title
Percent Change in Cushing's Disease Clinical Signs and Symptoms - Weight
Description
Clinically relevant threshold (at any time point) was reduction of ≥ 5%
Time Frame
Baseline, week 12, 24 and 48
Title
Percent Change in Cushing's Disease Clinical Signs and Symptoms - Muscle Strength
Description
Direct observation of ability to stand unaided: 0=able to stand easily with arms extended, 1=able to stand after several efforts without using arms as assistance, 2=able to stand only by using arms as assistance 3=completely unable to stand
Time Frame
Baseline, week 12, 24 and 48
Title
Percent Change in Cushing's Disease Clinical Signs and Symptoms - Waist Circumference
Description
Clinically relevant threshold (at any time point). Reduction of ≥ 5%, Reduction of ≥ 10%
Time Frame
Baseline, week 12, 24 and 48
Title
Percent Change in Cushing's Disease Clinical Signs and Symptoms - Hirsutism
Description
Change from baseline is shown as: Percent change from baseline (BL) =((Post BL value - BL value)/ BL value)*100. Ferriman-Gallway scoring was used: 0=minimum and 36 was maximum in females only.
Time Frame
Baseline, week 12, 24 and 48
Title
Percent Change From Baseline in Growth Hormone (GH) Values
Description
Descriptive summary of the effect of pasireotide on GH.
Time Frame
Baseline, week 12, 24 and 48
Title
Percent Change From Baseline in Insulin Growth Factor - 1 (IGF - 1) Values
Description
Descriptive summary of the effect of pasireotide on IGF-1
Time Frame
Baseline, week 12, 24 and 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: Written informed consent obtained prior to any screening procedures Male or female patients aged 18 years or greater Patients with confirmed diagnosis of Cushing's disease as evidenced by mean urinary free cortisol of three 24-hour urine samples collected during the 3-week screening period above the upper limit of the laboratory normal range morning plasma ACTH within the normal or above normal range either MRI confirmation of pituitary adenoma (greater than or equal to 0.6 cm), or inferior petrosal sinus gradient >3 after CRH stimulation for those patients with a microadenoma less than 0.6 cm, or for patients who have had prior pituitary surgery, histopathology confirming an ACTH staining adenoma. Patients with de novo Cushing's disease must not be considered as candidates for pituitary surgery (i.e. poor surgical candidates, surgically unapproachable tumors, patients with no visible pituitary tumor, patients who refuse to have surgical treatment) Karnofsky performance status >60 (i.e. requires occasional assistance, but is able to care for most of his personal needs) For patients on previous medical treatment for Cushing's disease the following washout periods must be completed before screening assessments are performed Inhibitors of steroidogenesis (e.g. ketoconazole, metyrapone, rosiglitazone): 1 week Dopamine agonists (e.g. bromocriptine, cabergoline): 4 weeks Mitotane: 6 months Octreotide LAR and Lanreotide autogel: 8 weeks Lanreotide SR: 4 weeks Octreotide (immediate release formulation): 1 week Glucocorticoid receptor inhibitor (mifepristone): 4 weeks Exclusion criteria: Radiotherapy of the pituitary <4 weeks before screening or patient who has not recovered from side effects Patients with compression of the optic chiasm causing acute clinically significant visual field defect Patients with Cushing's syndrome due to ectopic ACTH secretion Patients with hypercortisolism secondary to adrenal tumors or nodular (primary) bilateral adrenal hyperplasia Patients who have a known inherited syndrome as the cause for hormone over secretion (i.e. Carney Complex, McCune-Albright syndrome, MEN-1) Patients with a diagnosis of glucocorticoid-remedial aldosteronism (GRA) Patients who have undergone major surgery within 1 month prior to screening Patients with known gallbladder or bile duct disease, acute or chronic pancreatitis (patients with asymptomatic cholelithiasis and asymptomatic bile duct dilation can be included) Diabetic patients whose blood glucose is poorly controlled as evidenced by HbA1C >8% Patients who have clinically significant impairment in cardiovascular function or are at risk thereof, as evidenced by congestive heart failure (NYHA Class III or IV), unstable angina, sustained ventricular tachycardia, clinically significant bradycardia, high grade AV block, history of acute MI less than one year prior to study entry QTcF >450 msec at screening History of syncope or family history of idiopathic sudden death Risk factors for Torsades de Pointes such as uncorrected hypokalemia, uncorrected hypomagnesemia, cardiac failure Concomitant disease(s) that could prolong the QT interval such as autonomic neuropathy (caused by diabetes or Parkinson's disease), HIV, cirrhosis, uncontrolled hypothyroidism, concomitant medication(s) with known risk for TdP Patients with liver disease or history of liver disease such as cirrhosis, chronic active hepatitis B and C, or chronic persistent hepatitis, or patients with ALT or AST more than 2 x ULN, serum creatinine >2.0 x ULN, serum bilirubin >1.5 x ULN, serum albumin < 0.67 x LLN at screening Patients who have any current or prior medical condition that can interfere with the conduct of the study or the evaluation of its results, such as History of immunocompromise, including a positive HIV test result (Elisa and Western blot). An HIV test will not be required, however, previous medical history will be reviewed Presence of active or suspected acute or chronic uncontrolled infection History of, or current alcohol misuse/abuse in the 12 month period prior to screening Female patients who are pregnant or lactating, or are of childbearing potential and not practicing a medically acceptable method of birth control. If a woman is participating in the trial then one form of contraception is sufficient (pill or diaphragm) and the partner should use a condom. If oral contraception is used in addition to condoms, the patient must have been practicing this method for at least two months prior to screening and must agree to continue the oral contraceptive throughout the course of the study and for one month after the study has ended. Male patients who are sexually active are required to use condoms during the study and for three month afterwards as a precautionary measure (available data do not suggest any increased reproductive risk with the study drugs) Patients who have participated in any clinical investigation with an investigational drug within 1 month prior to screening or patients who have previously been treated with pasireotide Known hypersensitivity to somatostatin analogues Patients with a history of non-compliance to medical regimens or who are considered potentially unreliable or will be unable to complete the entire study Patients with presence of Hepatitis B surface antigen (HbsAg) Patients with presence of Hepatitis C antibody test (anti-HCV)
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
Advanced Research, LLC
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Facility Name
St Josephs Hospital & Medical Center St Joes
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
University of California at Los Angeles UCLA Tiverton
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
LA Biomedical Research at Harbor UCLA Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Emory University School of Medicine
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
John H Stroger Jr Hospital of Cook County
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60644
Country
United States
Facility Name
University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Diabetes and Endocrinology Associates, PC
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
University of New Mexico Hospital UNM
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Oregon Health and Science University OHSU 5
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
University of Pennsylvania Medical Center Univ Penn
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Allegheny Endocrinology Associates
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Mid South Endocrine Associates
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Facility Name
Swedish Cancer Institute Swedish Cancer Institute (SC)
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Novartis Investigative Site
City
Fortaleza
State/Province
CE
ZIP/Postal Code
04636-000
Country
Brazil
Facility Name
Novartis Investigative Site
City
Londrina
State/Province
PR
ZIP/Postal Code
86015-520
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
Joinville
State/Province
SC
ZIP/Postal Code
89201260
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
04029-000
Country
Brazil
Facility Name
Novartis Investigative Site
City
Prague 2
State/Province
Czech Republic
ZIP/Postal Code
128 00
Country
Czechia
Facility Name
Novartis Investigative Site
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Novartis Investigative Site
City
Augsburg
ZIP/Postal Code
86150
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
10098
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Novartis Investigative Site
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Novartis Investigative Site
City
Frankfurt
ZIP/Postal Code
60329
Country
Germany
Facility Name
Novartis Investigative Site
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Novartis Investigative Site
City
Goettingen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Novartis Investigative Site
City
Hamburg
ZIP/Postal Code
22587
Country
Germany
Facility Name
Novartis Investigative Site
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Novartis Investigative Site
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Novartis Investigative Site
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Novartis Investigative Site
City
Marburg
ZIP/Postal Code
35039
Country
Germany
Facility Name
Novartis Investigative Site
City
Muenchen
ZIP/Postal Code
80804
Country
Germany
Facility Name
Novartis Investigative Site
City
Oldenburg
ZIP/Postal Code
26122
Country
Germany
Facility Name
Novartis Investigative Site
City
Wurzburg
ZIP/Postal Code
97080
Country
Germany
Facility Name
Novartis Investigative Site
City
Athens
State/Province
GR
ZIP/Postal Code
115 27
Country
Greece
Facility Name
Novartis Investigative Site
City
Thessaloniki
State/Province
GR
ZIP/Postal Code
546 42
Country
Greece
Facility Name
Novartis Investigative Site
City
Athens
ZIP/Postal Code
106 76
Country
Greece
Facility Name
Novartis Investigative Site
City
Thessaloniki
ZIP/Postal Code
546 36
Country
Greece
Facility Name
Novartis Investigative Site
City
Seoul
State/Province
Korea
ZIP/Postal Code
02447
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seoul
State/Province
Korea
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Novartis Investigative Site
City
Ashrafieh
ZIP/Postal Code
166830
Country
Lebanon
Facility Name
Novartis Investigative Site
City
Bucharest
ZIP/Postal Code
011461
Country
Romania
Facility Name
Novartis Investigative Site
City
Bucuresti
ZIP/Postal Code
011863
Country
Romania
Facility Name
Novartis Investigative Site
City
Cluj
ZIP/Postal Code
400006
Country
Romania
Facility Name
Novartis Investigative Site
City
Iasi
ZIP/Postal Code
700106
Country
Romania
Facility Name
Novartis Investigative Site
City
Moscow
ZIP/Postal Code
129110
Country
Russian Federation
Facility Name
Novartis Investigative Site
City
Cordoba
State/Province
Andalucia
ZIP/Postal Code
14004
Country
Spain
Facility Name
Novartis Investigative Site
City
Granada
State/Province
Andalucia
ZIP/Postal Code
18003
Country
Spain
Facility Name
Novartis Investigative Site
City
Badalona
State/Province
Catalunya
ZIP/Postal Code
08916
Country
Spain
Facility Name
Novartis Investigative Site
City
Valencia
State/Province
Comunidad Valenciana
ZIP/Postal Code
46014
Country
Spain
Facility Name
Novartis Investigative Site
City
Valencia
State/Province
Comunidad Valenciana
ZIP/Postal Code
46026
Country
Spain
Facility Name
Novartis Investigative Site
City
Orense
State/Province
Galicia
ZIP/Postal Code
32005
Country
Spain
Facility Name
Novartis Investigative Site
City
Pontevedra
State/Province
Galicia
ZIP/Postal Code
36071
Country
Spain
Facility Name
Novartis Investigative Site
City
Palma De Mallorca
State/Province
Islas Baleares
ZIP/Postal Code
07120
Country
Spain
Facility Name
Novartis Investigative Site
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
Facility Name
Novartis Investigative Site
City
Songkla
ZIP/Postal Code
90110
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
31379734
Citation
Fleseriu M, Iweha C, Salgado L, Mazzuco TL, Campigotto F, Maamari R, Limumpornpetch P. Safety and Efficacy of Subcutaneous Pasireotide in Patients With Cushing's Disease: Results From an Open-Label, Multicenter, Single-Arm, Multinational, Expanded-Access Study. Front Endocrinol (Lausanne). 2019 Jul 16;10:436. doi: 10.3389/fendo.2019.00436. eCollection 2019.
Results Reference
derived

Learn more about this trial

An Open-label, Multi-center, Expanded Access Study of Pasireotide s.c. in Patients With Cushing's Disease.

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