Phase II Study Evaluating Efficacy, Safety and Pharmacokinetics of Pasireotide in Patients With Dumping Syndrome
Condition: Dumping Syndrome
MeSH terms: Dumping Syndrome; Syndrome
Intervention: SOM230
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
Intervention MeSH terms: Pasireotide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 43.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Dumping syndrome; SOM230; pasireotide LAR

Summary:

      multi-center, phase II study evaluating efficacy, safety and pharmacokinetics of pasireotide
      in patients with dumping syndrome
    

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).