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Phase II Study Evaluating Efficacy, Safety and Pharmacokinetics of Pasireotide in Patients With Dumping Syndrome

Primary Purpose

Dumping Syndrome

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
SOM230
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dumping Syndrome focused on measuring Dumping syndrome, SOM230, pasireotide LAR

Eligibility Criteria

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

Inclusion criteria:.

  • Male or female patients ≥ 18 years of age.
  • Post-gastric or esophageal bypass surgery, matching one of the criteria below:
  • Bariatric surgery: more than 6 months before signing the informed consent
  • Esophageal cancer surgery: were disease free at study entry
  • Gastric cancer surgery: were at stage 0 or I and were disease free at study entry
  • Patient with a documented diagnosis of Dumping Syndrome defined as having:
  • History of/or active symptoms associated with dumping syndrome (e.g. post-prandial tachycardia, bloating, diarrhea) and
  • Documented history of hypoglycemia based on either:
  • glucose <50 mg/dL or 2.8 mmol/L on a sporadic or scheduled blood analysis -or
  • glucose value <60 mg/dL or ≤ 3.3 mmol/L at 90, 120, 150 or 180 min during an OGTT
  • Patients had at least one glucose level <60 mg/dL (or ≤ 3.3 mmol/L) at 90, 120, 150 or 180 min during the 3-hour OGTT at screening.
  • Patients with esophageal cancer with a negative computed tomography (CT) or Magnetic resonance imaging (MRI) scan (neck, thoracic, and upper abdominal) and albumin

    ≥ 3.5 g/dl at baseline.

  • Patients with gastric cancer with a negative CT or MRI scan (total abdomen).
  • Karnofsky Performance Status ≥ 60 (i.e. required occasional assistance, but was able to care for most of their personal needs)
  • Patients who received other therapies for dumping syndrome (such as acarbose, gama guar, pectin) must have stopped all treatments and had a wash out period prior to signing the informed consent (i.e. at least 2 weeks between last previous therapy and first dose of study medication in this study).
  • Patients who had provided signed written informed consent prior to study participation.

Exclusion Criteria:

  • Bariatric patients who had lap band.
  • Patients with a current diagnosis of diabetes mellitus.
  • Patients who had failed treatment with somatostatin analogues for dumping syndrome in the past.
  • Patients who had been treated with somatostatin analogues in the past, must have had an appropriate interval between the last administration of somatostatin analogues treatment and the study drug as follows
  • Octreotide sc for ≥ 72 hours
  • Octreotide LAR for ≥ 56 days (8 weeks)
  • Lanreotide Autogel for ≥ 98 days (14 weeks)
  • Lanreotide SR ≥ 28 days (4 weeks)
  • Patients who were already treated with pasireotide.
  • Patients who had a known hypersensitivity to somatostatin analogues.
  • Patients who were receiving anti-cancer therapy (chemotherapy and/or radiotherapy).
  • Patients who had any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as:
  • Patients with the presence of active or suspected acute or chronic uncontrolled infection or with a history of immunodeficiency, including a positive human immunodeficiency virus (HIV) test result (ELISA and Western blot). An HIV test was not required; however, previous medical history was reviewed.
  • Non-malignant medical illnesses that were uncontrolled or whose control may have been jeopardized by the treatment with this study treatment.
  • Life-threatening autoimmune and ischemic disorders.
  • Patients with the presence of active or suspected acute or chronic uncontrolled infection.

Inadequate end organ function as defined by:

  • Inadequate bone marrow function:
  • White blood cells (WBC) <2.5 x 109/L
  • Absolute neutrophil count <1.5 x 109/L
  • Platelets <100 x 109/L
  • Hemoglobin <9 g/dL
  • International normalized ratio (INR) ≥ 1.3
  • Serum creatinine >2.0 mg/dL
  • Alkaline phosphatase (ALP) >2.5 x upper limit of normal (ULN)
  • Serum total bilirubin >1.5 x ULN
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) >2 x ULN
  • History of liver disease, such as cirrhosis or chronic active hepatitis B and C.
  • Presence of Hepatitis B surface antigen (HbsAg) and/ or presence of Hepatitis C antibody test (anti-Hepatitis C Virus).

Sites / Locations

  • Ximed Center for Weight Management Ximed Research
  • Stanford University Medical Center SC - SOM230X2203
  • Mayo Clinic - Rochester Mayo MN
  • Montefiore Medical Center CLCZ696B2320
  • Texas Tech University Health Science Center
  • Virginia Endocrinology Research 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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SOM230

Arm Description

Subjects with dumping syndrome treated with pasireotide

Outcomes

Primary Outcome Measures

Response Rate in Plasma Glucose Level
Response rate is defined as percentage of patients with no glucose values < 60 mg/dL at 90,120, 150 and 180 min during the Oral Glucose Tolerance Test (OGTT) at the end of s.c. dose escalation phase

Secondary Outcome Measures

Response Rate in Plasma Glucose Level
Response rate is defined as percentage of patients with no glucose values < 60 mg/dL at 90,120, 150 and 180 min during the Oral Glucose Tolerance Test (OGTT) at the end of 6 months (end of LAR/Core phase) and at the end of 12 months (extension phase)
Response Rate in Pulse Rate
Pulse rate was defined as percentage of patients with change in pulse rate >=10 bpm from pre-OGTT to 30 minutes post OGTT.
Response Rate in Hematocrit Levels
Percentage of patients with change in hematocrit >= 3% from pre-OGTT to 30 minutes post OGTT.
Insulin Levels During OGTT
Absolute insulin levels at the end of M3, M6, M12
Glucagon Levels During OGTT
Absolute glucagon levels at the end of Months 3, 6 & 12
Glucagon-like Peptide 1 (GLP-1) Levels During OGTT
Absolute Glucagon-like peptide 1 (GLP-1) levels at the end of at the end of Months 3, 6 and 12 at different time points.
Gastric Inhibitory Polypeptide (GIP) Levels at During OGTT
Absolute Gastric Inhibitory Polypeptide (GIP) levels at the end of Months 3, 6 and 12 at different time points.
Health-related Quality of Live (HRQoL) Short Form- 36 (SF-36) Score(s)
Absolute HRQoL SF-36 Scores at end of the Months 3, 6 and 12 from s.c. baseline. SF-36, a 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting. Items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively.
Dumping Severity Score (DSS) at the End of Months 3, 6 and 8
Absolute Dumping Severity Score (DSS) scores at end of M3, M6 & M8. At study start patients were assessed using DSS (older version of DSQ); however after the implementation of protocol amendment 2, all patients were expected to use DSQ. No results available for M12 as last patient that answered the DSS was at M8. DSS = disease-specific patient (Pt.) reported outcome (PRO) questionnaire uses a 4-point Likert scale (0, absent; 1, mild; 2, relevant; 3, severe; 4) to ask Pt. to evaluate intensity of early dumping symptoms (within 30 minutes (<30 minutes) after food ingestion). The questionnaire also evaluates 65 late dumping symptoms (more than 1.5 hours (>90 minutes) after food ingestion). Early & late dumping score calculated by adding the scores of the respective questions. Cumulative dumping score is obtained by adding early & late scores. DSS Range (min (absent) - max (severe)): Early dumping: 0-24; Late Dumping: 0-18; Cumulative: 0-42. Lower scores represent a better outcome.
Dumping Score Questionnaire (DSQ) at the End of Months 3, 6 and 12
Absolute Dumping Score Questionnaire (DSQ) scores at end of Months 3, 6 & 12 from s.c. baseline. DSQ = disease-specific PRO scale. The questionnaire uses a 5-point Likert scale (0, none; 1, mild; 2, moderate; 3, severe; 4, very severe) to ask Pt. to evaluate intensity of 10 early dumping symptoms (within 30 minutes (<30 minutes) after food ingestion). The questionnaire also evaluates 5 late dumping symptoms (more than 1.5 hours (>90 minutes) after food ingestion). Early & late dumping score calculated by adding the scores of respective questions. A cumulative dumping score is obtained by adding early & late scores. At study start patients were assessed using DSS (older version of DSQ); however after the implementation of protocol amendment 2, all patients used DSQ. DSQ Range: (min (None) - max (Very severe)): Early dumping: 0-40; Late Dumping: 0-20; Cumulative: 0-60. Lower scores represent a better outcome.
Patient Global Assessment at the End of Months 3, 6 and 12
Treatment with pasireotide LAR (both early and late dumping scores), was assessed by patient global assessment. Patient Global Assessment served as an additional approach to symptom based measurement by DSQ. It incorporated a patient global assessment question: "Considering all the ways that your disease affects you, rate how you are feeling during the last 7 days compared with your situation before starting the study" .Patients Global Assessment was measured utilizing a 7 point scale (from 1=a lot worse to 7= a lot better).
Plasma Pharmacokinetic (PK) Parameter of Pasireotide: Cmax, ss (Steady State) and Ctrough, ss, After s.c. Injection
A pre-dose PK blood sample was collected before the morning pasireotide s.c. dose of 50 μg, 100 ug, 150 ug and 200 ug. OGTT was performed right after the morning s.c. dose (Time point zero); additional PK blood samples were collected at the same time points as the OGTT evaluation at 30, 60, 90, 120, 150 and 180 minutes. 'n' = number of subjects with non-missing values
Plasma Pharmacokinetic (PK) Parameter of Pasireotide: AUC0-3h, ss, After s.c. Injection
A pre-dose PK blood sample was collected before the morning pasireotide s.c. dose of 50 μg, 100 ug, 150 ug and 200 ug. OGTT was performed right after the morning s.c. dose (Time point zero); additional PK blood samples were collected at the same time points as the OGTT evaluation at 30, 60, 90, 120, 150 and 180 minutes.
Plasma Pharmacokinetic (PK) Parameter of Pasireotide: Tmax, ss, After s.c. Injection
A pre-dose PK blood sample was collected before the morning pasireotide s.c. dose of 50 μg, 100 ug, 150 ug and 200 ug. OGTT was performed right after the morning s.c. dose (Time point zero); additional PK blood samples were collected at the same time points as the OGTT evaluation at 30, 60, 90, 120, 150 and 180 minutes.
Plasma PK Parameter of AUC0-3h, d21, End _inj and AUC0-3h, d28, 3rd_inj Associated With LAR (LAR Core Phase)
Summary of LAR PK Parameters by Dose
Summary of plasma PK parameter Cmax, p2 , 2nd injection and Ctrough, d28 associated with LAR injection (LAR Core phase)
Pasireotide Concentrations in LAR Phase
Summary of pasireotide concentrations following monthly i.m. injections of pasireotide LAR by incident dose (LAR Pharmacokinetic set)
LAR PK Parameter: Ctrough - at Steady State (ss) by Dose
In the LAR treatment phase, monthly injections of pasireotide LAR 10, 20, 30 and 40 mg were given to participants and trough concentration at steady state (Ctrough,ss) were obtained but due to only 1 participant in the 40mg arm, standard deviation could not be calculated.

Full Information

First Posted
May 9, 2012
Last Updated
March 31, 2017
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01637272
Brief Title
Phase II Study Evaluating Efficacy, Safety and Pharmacokinetics of Pasireotide in Patients With Dumping Syndrome
Official Title
A Multi-center, Intra-patient Dose Escalation Phase II Study to Evaluate the Preliminary Efficacy, Safety and Pharmacokinetics of Pasireotide (SOM230) Subcutaneous (s.c.) Followed by Pasireotide LAR in Patients With Dumping Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
January 8, 2013 (Actual)
Primary Completion Date
August 7, 2015 (Actual)
Study Completion Date
August 7, 2015 (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
multi-center, phase II study evaluating efficacy, safety and pharmacokinetics of pasireotide in patients with dumping syndrome
Detailed Description
43 adult patients with dumping syndrome received pasireotide s.c. during the dose escalation phase (3 months dose could be increased based on the presence of hypoglycemia during OGTT). After completing Month 3, patients were switched to pasireotide LAR for 3 months (up to Month 6). The core phase of the study was completed at the end of Month 6. Patients were allowed to enter the 6 month extension phase if they experienced benefit with pasireotide LAR treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dumping Syndrome
Keywords
Dumping syndrome, SOM230, pasireotide LAR

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SOM230
Arm Type
Experimental
Arm Description
Subjects with dumping syndrome treated with pasireotide
Intervention Type
Drug
Intervention Name(s)
SOM230
Other Intervention Name(s)
pasireotide
Intervention Description
Pasireotide (SOM230) sc injection was provided as solution for injection in individual 1-point-cut 1 mL ampule, containing nominally 200 μg of pasireotide (as free base). Doses: 50, 100, 150 and 200 μg. Pasireotide im LAR depot injection was provided as micro particles powder in vials containing nominally 10, 20, 40 & 60 mg of pasireotide (as free base) & solvent for suspension for injection in ampules for the reconstitution of the LAR micro particles. Doses: 10, 20, 30, 40 or 60 mg
Primary Outcome Measure Information:
Title
Response Rate in Plasma Glucose Level
Description
Response rate is defined as percentage of patients with no glucose values < 60 mg/dL at 90,120, 150 and 180 min during the Oral Glucose Tolerance Test (OGTT) at the end of s.c. dose escalation phase
Time Frame
at Month 3 (M3)
Secondary Outcome Measure Information:
Title
Response Rate in Plasma Glucose Level
Description
Response rate is defined as percentage of patients with no glucose values < 60 mg/dL at 90,120, 150 and 180 min during the Oral Glucose Tolerance Test (OGTT) at the end of 6 months (end of LAR/Core phase) and at the end of 12 months (extension phase)
Time Frame
at Month 6 (M6), Month 12 (M12)
Title
Response Rate in Pulse Rate
Description
Pulse rate was defined as percentage of patients with change in pulse rate >=10 bpm from pre-OGTT to 30 minutes post OGTT.
Time Frame
at baseline, M3, M6, M12
Title
Response Rate in Hematocrit Levels
Description
Percentage of patients with change in hematocrit >= 3% from pre-OGTT to 30 minutes post OGTT.
Time Frame
M3, M6, M12
Title
Insulin Levels During OGTT
Description
Absolute insulin levels at the end of M3, M6, M12
Time Frame
M3, M6, M12
Title
Glucagon Levels During OGTT
Description
Absolute glucagon levels at the end of Months 3, 6 & 12
Time Frame
M3, M6, M12
Title
Glucagon-like Peptide 1 (GLP-1) Levels During OGTT
Description
Absolute Glucagon-like peptide 1 (GLP-1) levels at the end of at the end of Months 3, 6 and 12 at different time points.
Time Frame
M3, M6, M12
Title
Gastric Inhibitory Polypeptide (GIP) Levels at During OGTT
Description
Absolute Gastric Inhibitory Polypeptide (GIP) levels at the end of Months 3, 6 and 12 at different time points.
Time Frame
M3, M6, M12
Title
Health-related Quality of Live (HRQoL) Short Form- 36 (SF-36) Score(s)
Description
Absolute HRQoL SF-36 Scores at end of the Months 3, 6 and 12 from s.c. baseline. SF-36, a 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting. Items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively.
Time Frame
M3, M6, M12
Title
Dumping Severity Score (DSS) at the End of Months 3, 6 and 8
Description
Absolute Dumping Severity Score (DSS) scores at end of M3, M6 & M8. At study start patients were assessed using DSS (older version of DSQ); however after the implementation of protocol amendment 2, all patients were expected to use DSQ. No results available for M12 as last patient that answered the DSS was at M8. DSS = disease-specific patient (Pt.) reported outcome (PRO) questionnaire uses a 4-point Likert scale (0, absent; 1, mild; 2, relevant; 3, severe; 4) to ask Pt. to evaluate intensity of early dumping symptoms (within 30 minutes (<30 minutes) after food ingestion). The questionnaire also evaluates 65 late dumping symptoms (more than 1.5 hours (>90 minutes) after food ingestion). Early & late dumping score calculated by adding the scores of the respective questions. Cumulative dumping score is obtained by adding early & late scores. DSS Range (min (absent) - max (severe)): Early dumping: 0-24; Late Dumping: 0-18; Cumulative: 0-42. Lower scores represent a better outcome.
Time Frame
M3, M6, M8
Title
Dumping Score Questionnaire (DSQ) at the End of Months 3, 6 and 12
Description
Absolute Dumping Score Questionnaire (DSQ) scores at end of Months 3, 6 & 12 from s.c. baseline. DSQ = disease-specific PRO scale. The questionnaire uses a 5-point Likert scale (0, none; 1, mild; 2, moderate; 3, severe; 4, very severe) to ask Pt. to evaluate intensity of 10 early dumping symptoms (within 30 minutes (<30 minutes) after food ingestion). The questionnaire also evaluates 5 late dumping symptoms (more than 1.5 hours (>90 minutes) after food ingestion). Early & late dumping score calculated by adding the scores of respective questions. A cumulative dumping score is obtained by adding early & late scores. At study start patients were assessed using DSS (older version of DSQ); however after the implementation of protocol amendment 2, all patients used DSQ. DSQ Range: (min (None) - max (Very severe)): Early dumping: 0-40; Late Dumping: 0-20; Cumulative: 0-60. Lower scores represent a better outcome.
Time Frame
M3, M6, M12
Title
Patient Global Assessment at the End of Months 3, 6 and 12
Description
Treatment with pasireotide LAR (both early and late dumping scores), was assessed by patient global assessment. Patient Global Assessment served as an additional approach to symptom based measurement by DSQ. It incorporated a patient global assessment question: "Considering all the ways that your disease affects you, rate how you are feeling during the last 7 days compared with your situation before starting the study" .Patients Global Assessment was measured utilizing a 7 point scale (from 1=a lot worse to 7= a lot better).
Time Frame
M3, M6, M12
Title
Plasma Pharmacokinetic (PK) Parameter of Pasireotide: Cmax, ss (Steady State) and Ctrough, ss, After s.c. Injection
Description
A pre-dose PK blood sample was collected before the morning pasireotide s.c. dose of 50 μg, 100 ug, 150 ug and 200 ug. OGTT was performed right after the morning s.c. dose (Time point zero); additional PK blood samples were collected at the same time points as the OGTT evaluation at 30, 60, 90, 120, 150 and 180 minutes. 'n' = number of subjects with non-missing values
Time Frame
M1 to M3
Title
Plasma Pharmacokinetic (PK) Parameter of Pasireotide: AUC0-3h, ss, After s.c. Injection
Description
A pre-dose PK blood sample was collected before the morning pasireotide s.c. dose of 50 μg, 100 ug, 150 ug and 200 ug. OGTT was performed right after the morning s.c. dose (Time point zero); additional PK blood samples were collected at the same time points as the OGTT evaluation at 30, 60, 90, 120, 150 and 180 minutes.
Time Frame
M1 to M3
Title
Plasma Pharmacokinetic (PK) Parameter of Pasireotide: Tmax, ss, After s.c. Injection
Description
A pre-dose PK blood sample was collected before the morning pasireotide s.c. dose of 50 μg, 100 ug, 150 ug and 200 ug. OGTT was performed right after the morning s.c. dose (Time point zero); additional PK blood samples were collected at the same time points as the OGTT evaluation at 30, 60, 90, 120, 150 and 180 minutes.
Time Frame
M1 to M3
Title
Plasma PK Parameter of AUC0-3h, d21, End _inj and AUC0-3h, d28, 3rd_inj Associated With LAR (LAR Core Phase)
Time Frame
M4 to M6
Title
Summary of LAR PK Parameters by Dose
Description
Summary of plasma PK parameter Cmax, p2 , 2nd injection and Ctrough, d28 associated with LAR injection (LAR Core phase)
Time Frame
M4 to M6
Title
Pasireotide Concentrations in LAR Phase
Description
Summary of pasireotide concentrations following monthly i.m. injections of pasireotide LAR by incident dose (LAR Pharmacokinetic set)
Time Frame
M7 to M12
Title
LAR PK Parameter: Ctrough - at Steady State (ss) by Dose
Description
In the LAR treatment phase, monthly injections of pasireotide LAR 10, 20, 30 and 40 mg were given to participants and trough concentration at steady state (Ctrough,ss) were obtained but due to only 1 participant in the 40mg arm, standard deviation could not be calculated.
Time Frame
M4 to M12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:. Male or female patients ≥ 18 years of age. Post-gastric or esophageal bypass surgery, matching one of the criteria below: Bariatric surgery: more than 6 months before signing the informed consent Esophageal cancer surgery: were disease free at study entry Gastric cancer surgery: were at stage 0 or I and were disease free at study entry Patient with a documented diagnosis of Dumping Syndrome defined as having: History of/or active symptoms associated with dumping syndrome (e.g. post-prandial tachycardia, bloating, diarrhea) and Documented history of hypoglycemia based on either: glucose <50 mg/dL or 2.8 mmol/L on a sporadic or scheduled blood analysis -or glucose value <60 mg/dL or ≤ 3.3 mmol/L at 90, 120, 150 or 180 min during an OGTT Patients had at least one glucose level <60 mg/dL (or ≤ 3.3 mmol/L) at 90, 120, 150 or 180 min during the 3-hour OGTT at screening. Patients with esophageal cancer with a negative computed tomography (CT) or Magnetic resonance imaging (MRI) scan (neck, thoracic, and upper abdominal) and albumin ≥ 3.5 g/dl at baseline. Patients with gastric cancer with a negative CT or MRI scan (total abdomen). Karnofsky Performance Status ≥ 60 (i.e. required occasional assistance, but was able to care for most of their personal needs) Patients who received other therapies for dumping syndrome (such as acarbose, gama guar, pectin) must have stopped all treatments and had a wash out period prior to signing the informed consent (i.e. at least 2 weeks between last previous therapy and first dose of study medication in this study). Patients who had provided signed written informed consent prior to study participation. Exclusion Criteria: Bariatric patients who had lap band. Patients with a current diagnosis of diabetes mellitus. Patients who had failed treatment with somatostatin analogues for dumping syndrome in the past. Patients who had been treated with somatostatin analogues in the past, must have had an appropriate interval between the last administration of somatostatin analogues treatment and the study drug as follows Octreotide sc for ≥ 72 hours Octreotide LAR for ≥ 56 days (8 weeks) Lanreotide Autogel for ≥ 98 days (14 weeks) Lanreotide SR ≥ 28 days (4 weeks) Patients who were already treated with pasireotide. Patients who had a known hypersensitivity to somatostatin analogues. Patients who were receiving anti-cancer therapy (chemotherapy and/or radiotherapy). Patients who had any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as: Patients with the presence of active or suspected acute or chronic uncontrolled infection or with a history of immunodeficiency, including a positive human immunodeficiency virus (HIV) test result (ELISA and Western blot). An HIV test was not required; however, previous medical history was reviewed. Non-malignant medical illnesses that were uncontrolled or whose control may have been jeopardized by the treatment with this study treatment. Life-threatening autoimmune and ischemic disorders. Patients with the presence of active or suspected acute or chronic uncontrolled infection. Inadequate end organ function as defined by: Inadequate bone marrow function: White blood cells (WBC) <2.5 x 109/L Absolute neutrophil count <1.5 x 109/L Platelets <100 x 109/L Hemoglobin <9 g/dL International normalized ratio (INR) ≥ 1.3 Serum creatinine >2.0 mg/dL Alkaline phosphatase (ALP) >2.5 x upper limit of normal (ULN) Serum total bilirubin >1.5 x ULN Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) >2 x ULN History of liver disease, such as cirrhosis or chronic active hepatitis B and C. Presence of Hepatitis B surface antigen (HbsAg) and/ or presence of Hepatitis C antibody test (anti-Hepatitis C Virus).
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
Ximed Center for Weight Management Ximed Research
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Stanford University Medical Center SC - SOM230X2203
City
Stanford
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Mayo Clinic - Rochester Mayo MN
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Montefiore Medical Center CLCZ696B2320
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Texas Tech University Health Science Center
City
El Paso
State/Province
Texas
ZIP/Postal Code
79905
Country
United States
Facility Name
Virginia Endocrinology Research SC
City
Chesapeake
State/Province
Virginia
ZIP/Postal Code
23321
Country
United States
Facility Name
Novartis Investigative Site
City
Brugge
ZIP/Postal Code
8310
Country
Belgium
Facility Name
Novartis Investigative Site
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Novartis Investigative Site
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Novartis Investigative Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Novartis Investigative Site
City
Paris Cedex 13
ZIP/Postal Code
75651
Country
France
Facility Name
Novartis Investigative Site
City
Pessac Cedex
ZIP/Postal Code
33604
Country
France
Facility Name
Novartis Investigative Site
City
Pierre-Benite Cedex
ZIP/Postal Code
69495
Country
France
Facility Name
Novartis Investigative Site
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Novartis Investigative Site
City
Würzburg
ZIP/Postal Code
97080
Country
Germany
Facility Name
Novartis Investigative Site
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Utrecht
ZIP/Postal Code
3584CX
Country
Netherlands

12. IPD Sharing Statement

Learn more about this trial

Phase II Study Evaluating Efficacy, Safety and Pharmacokinetics of Pasireotide in Patients With Dumping Syndrome

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