Cushing's DiseasePhase 3SEASCAPENCT01582061
An Open-label, Multi-center, Expanded Access Study of Pasireotide s.c. in Patients With Cushing's Disease.
A Phase 3 study testing Pasireotide sub-cutaneous in people with Cushing's Disease, run by Novartis Pharmaceuticals at 65 sites in 11 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cushing's Disease
- What is being tested?
- Pasireotide sub-cutaneous
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 65 sitesin 11 countries
- Study dates
- 16 Aug 2011to 26 Jan 2017
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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)
Show all 25Show fewer
- 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)
Trial locations and contacts
65 sites in 11 countries.
65 sites in 11 countries
United States17 sites
University of New Mexico Hospital UNM
Albuquerque, New Mexico, 87106
Emory University School of Medicine
Atlanta, Georgia, 30322
University of Maryland Medical Center
Baltimore, Maryland, 21201
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, 60644
University of California at Los Angeles UCLA Tiverton
Los Angeles, California, 90095
Mid South Endocrine Associates
Nashville, Tennessee, 37203
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
Mount Sinai School of Medicine
New York, New York, 10029
Diabetes and Endocrinology Associates, PC
Omaha, Nebraska, 68131
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Advanced Research, LLC
Peoria, Arizona, 85381
University of Pennsylvania Medical Center Univ Penn
Philadelphia, Pennsylvania, 19104
St Josephs Hospital & Medical Center St Joes
Phoenix, Arizona, 85013
Allegheny Endocrinology Associates
Pittsburgh, Pennsylvania, 15212
Oregon Health and Science University OHSU 5
Portland, Oregon, 97239
Swedish Cancer Institute Swedish Cancer Institute (SC)
Seattle, Washington, 98104
LA Biomedical Research at Harbor UCLA Medical Center
Torrance, California, 90502
Germany16 sites
Novartis Investigative Site
Aachen, 52074
Novartis Investigative Site
Augsburg, 86150
Novartis Investigative Site
Berlin, 10098
Novartis Investigative Site
Berlin, 13353
Novartis Investigative Site
Erlangen, 91054
Novartis Investigative Site
Frankfurt, 60329
Novartis Investigative Site
Frankfurt, 60590
Novartis Investigative Site
Göttingen, 37075
Novartis Investigative Site
Hamburg, 22587
Novartis Investigative Site
Heidelberg, 69120
Novartis Investigative Site
Leipzig, 04103
Novartis Investigative Site
Mainz, 55131
Novartis Investigative Site
Marburg, 35039
Novartis Investigative Site
München, 80804
Novartis Investigative Site
Oldenburg, 26122
Novartis Investigative Site
Würzburg, 97080
Spain8 sites
Novartis Investigative Site
Badalona, Catalonia, 08916
Novartis Investigative Site
Córdoba, Andalusia, 14004
Novartis Investigative Site
Granada, Andalusia, 18003
Novartis Investigative Site
Ourense, Galicia, 32005
Novartis Investigative Site
Palma de Mallorca, Balearic Islands, 07120
Novartis Investigative Site
Pontevedra, Galicia, 36071
Novartis Investigative Site
Valencia, Valencia, 46014
Novartis Investigative Site
Valencia, Valencia, 46026
Brazil7 sites
Novartis Investigative Site
Fortaleza, Ceará, 04636-000
Novartis Investigative Site
Joinville, Santa Catarina, 89201260
Novartis Investigative Site
Londrina, Paraná, 86015-520
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul, 90560-030
Novartis Investigative Site
Rio de Janeiro, Rio de Janeiro, 21941-913
Novartis Investigative Site
São Paulo, São Paulo, 04029-000
Novartis Investigative Site
São Paulo, São Paulo, 05403 000
Greece4 sites
Novartis Investigative Site
Athens, GR, 115 27
Novartis Investigative Site
Athens, 106 76
Novartis Investigative Site
Thessaloniki, GR, 546 42
Novartis Investigative Site
Thessaloniki, 546 36
Romania4 sites
Novartis Investigative Site
Bucharest, 011461
Novartis Investigative Site
Bucharest, 011863
Novartis Investigative Site
Cluj-Napoca, 400006
Novartis Investigative Site
Iași, 700106
South Korea4 sites
Novartis Investigative Site
Seoul, Korea, 02447
Novartis Investigative Site
Seoul, Korea, 06351
Novartis Investigative Site
Seoul, 03080
Novartis Investigative Site
Seoul, 03722
Thailand2 sites
Novartis Investigative Site
Bangkok, 10330
Novartis Investigative Site
Songkhla, 90110
About this study
Official title: An Open-label, Multi-center, Expanded Access Study of Pasireotide s.c. in Patients With Cushing's Disease (Seascape).
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.
Read the 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.
- Conditions
- Cushing's Disease
- Being tested
- Pasireotide sub-cutaneous
- Keywords
- Cushing's disease, Hormone disorder, Cortisol, Adrenocorticotropic hormone, Pituitary tumor, SOM230, adult
- Medical subject headings
- Pituitary ACTH Hypersecretion, Pituitary Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pasireotide sub-cutaneousDrug
Also called SOM230 sub-cutaneous
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
| Study group | Role | What they receive |
|---|---|---|
| Pasireotide 600 μg | Experimental | 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. Receives: Drug: Pasireotide sub-cutaneous |
| Pasireotide 900 μg | Experimental | 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 Receives: Drug: Pasireotide sub-cutaneous |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline up to approximately 256 weeks
Secondary outcomes (13)
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.
Measured: Baseline, week 12, 24 and 48
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.
Measured: Baseline, week 12, 24 and 48
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.
Measured: Baseline, week 12, 24 and 48
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.
Measured: Baseline, week 12, 24 and 48
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
Measured: Baseline, week 12, 24 and 48
Percent Change in Cushing's Disease Clinical Signs and Symptoms - Temperature
degrees celius
Measured: Baseline week 12, 24 and 48
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
Measured: Baseline, week 12, 24 and 48
Percent Change in Cushing's Disease Clinical Signs and Symptoms - Weight
Clinically relevant threshold (at any time point) was reduction of ≥ 5%
Measured: Baseline, week 12, 24 and 48
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
Measured: Baseline, week 12, 24 and 48
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%
Measured: Baseline, week 12, 24 and 48
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.
Measured: Baseline, week 12, 24 and 48
Percent Change From Baseline in Growth Hormone (GH) Values
Descriptive summary of the effect of pasireotide on GH.
Measured: Baseline, week 12, 24 and 48
Percent Change From Baseline in Insulin Growth Factor - 1 (IGF - 1) Values
Descriptive summary of the effect of pasireotide on IGF-1
Measured: Baseline, week 12, 24 and 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2012 (estimated)
- Study start16 Aug 2011
- Primary completion26 Jan 2017
- Study completion26 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cushing's DiseaseStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01582061
- Sponsor's protocol ID
- CSOM230B2406
- Acronym
- SEASCAPE
- Status last verified
- May 2018
- First submitted
- 12 Apr 2012
- Last updated
- 19 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 31379734
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multi-center, Expanded Access Study of Pasireotide s.c. in Patients With Cushing's Disease (Seascape).
- ClinicalTrials.gov ID
- NCT01582061
- Acronym / sponsor ID
- SEASCAPE / CSOM230B2406
- Conditions
- Cushing's Disease
- Keywords
- Cushing's disease, Hormone disorder, Cortisol, Adrenocorticotropic hormone, Pituitary tumor, SOM230, adult
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 16 Aug 2011 (actual)
- Primary completion
- 26 Jan 2017 (actual)
- Study completion
- 26 Jan 2017 (actual)
- First posted
- 20 Apr 2012 (estimated)
- Results
- Posted 19 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pasireotide 600 μg | Experimental | Drug: Pasireotide sub-cutaneousPasireotide 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 900 μg | Experimental | Drug: Pasireotide sub-cutaneousPasireotide 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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)
Key exclusion criteria (25 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pasireotide sub-cutaneousAlso: SOM230 sub-cutaneousPasireotide 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 | Drug | Pasireotide 600 μg, Pasireotide 900 μg |
Primary outcome
Percentage of Patients With a Drug-related Adverse Event That is Recorded as Grade 3 or 4 or as a Serious Adverse Event (SAE)
Time frame: Baseline up to approximately 256 weeks
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.
13 secondary outcomes
Percentage of Patients With Mean Urinary Free Cortisol (UFC) ≤ Upper Limit of Normal (ULN)
Time frame: Baseline, week 12, 24 and 48
Percentage of Patients Achieving a Reduction of Mean UFC ≥ 50% From Baseline
Time frame: Baseline, week 12, 24 and 48
Percent Change in Cushing Quality of Life and Work Productivity and Activity Impairment-General Health (WPAI-GH) Scores
Time frame: Baseline, week 12, 24 and 48
Percent Change in Cushing's Disease Clinical Signs and Symptoms - Blood Pressure (BP)
Time frame: Baseline, week 12, 24 and 48
Percent Change in Cushing's Disease Clinical Signs and Symptoms - Pulse
Time frame: Baseline, week 12, 24 and 48
Percent Change in Cushing's Disease Clinical Signs and Symptoms - Temperature
Time frame: Baseline week 12, 24 and 48
Percent Change in Cushing's Disease Clinical Signs and Symptoms - Body Mass Index (BMI)
Time frame: Baseline, week 12, 24 and 48
Percent Change in Cushing's Disease Clinical Signs and Symptoms - Weight
Time frame: Baseline, week 12, 24 and 48
Percent Change in Cushing's Disease Clinical Signs and Symptoms - Muscle Strength
Time frame: Baseline, week 12, 24 and 48
Percent Change in Cushing's Disease Clinical Signs and Symptoms - Waist Circumference
Time frame: Baseline, week 12, 24 and 48
Percent Change in Cushing's Disease Clinical Signs and Symptoms - Hirsutism
Time frame: Baseline, week 12, 24 and 48
Percent Change From Baseline in Growth Hormone (GH) Values
Time frame: Baseline, week 12, 24 and 48
Percent Change From Baseline in Insulin Growth Factor - 1 (IGF - 1) Values
Time frame: Baseline, week 12, 24 and 48
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31379734Fleseriu 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
65 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pasireotide sub-cutaneous in people with Cushing's Disease, run by Novartis Pharmaceuticals at 65 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 65 sites in United States, Germany, Spain, Brazil, Greece and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Patients With a Drug-related Adverse Event That is Recorded as Grade 3 or 4 or as a Serious Adverse Event (SAE) (time frame: Baseline up to approximately 256 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01582061, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2018.