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

NCT ID: NCT01637272

Last Updated: 2017-05-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 43 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-08
• Study Completion Date: 2015-08-07

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.

Conditions

Dumping Syndrome

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SOM230

Subjects with dumping syndrome treated with pasireotide

Group Type: EXPERIMENTAL

SOM230

Intervention Type: DRUG

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

Interventions

SOM230

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 Type: DRUG

Other Intervention Names

pasireotide

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Ximed Center for Weight Management Ximed Research

La Jolla, California, United States

Stanford University Medical Center SC - SOM230X2203

Stanford, California, United States

Mayo Clinic - Rochester Mayo MN

Rochester, Minnesota, United States

Montefiore Medical Center CLCZ696B2320

The Bronx, New York, United States

Texas Tech University Health Science Center

El Paso, Texas, United States

Virginia Endocrinology Research SC

Chesapeake, Virginia, United States

Novartis Investigative Site

Bruges, Belgium, Belgium

Novartis Investigative Site

Brussels, , Belgium

Novartis Investigative Site

Ghent, , Belgium

Novartis Investigative Site

Leuven, , Belgium

Novartis Investigative Site

Paris, , France

Novartis Investigative Site

Pessac, , France

Novartis Investigative Site

Pierre-Bénite, , France

Novartis Investigative Site

Hamburg, , Germany

Novartis Investigative Site

Würzburg, , Germany

Novartis Investigative Site

Utrecht, Netherlands, Netherlands

Novartis Investigative Site

Groningen, , Netherlands

Countries

United States; Belgium; France; Germany; Netherlands

Other Identifiers

2012-001534-34

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CSOM230X2203

Identifier Type: -

Identifier Source: org_study_id