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

NCT01637272 | Completed Phase 2 Results

• 2 other identifiers: CSOM230X22032012-001534-34
• Study Type: interventional
• Target: 43
• Locations: 5 countries
• Sites: 17

Brief Summary

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

Conditions

Dumping Syndrome

Keywords

Dumping syndrome; SOM230; pasireotide LAR

Outcome Measures

Primary Outcomes (1)

• 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

  at Month 3 (M3)

Secondary Outcomes (18)

• Response Rate in Plasma Glucose Level

  at Month 6 (M6), Month 12 (M12)

• Response Rate in Pulse Rate

  at baseline, M3, M6, M12

• Response Rate in Hematocrit Levels

  M3, M6, M12

• Insulin Levels During OGTT

  M3, M6, M12

• Glucagon Levels During OGTT

  M3, M6, M12

Study Arms (1)

SOM230

EXPERIMENTAL

Subjects with dumping syndrome treated with pasireotide

Drug: SOM230

Interventions

SOM230 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

Also known as: pasireotide

SOM230

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (17)

Ximed Center for Weight Management Ximed Research

La Jolla, California, 92037, United States

Location

Stanford University Medical Center SC - SOM230X2203

Stanford, California, 94304, United States

Location

Mayo Clinic - Rochester Mayo MN

Rochester, Minnesota, 55905, United States

Location

Montefiore Medical Center CLCZ696B2320

The Bronx, New York, 10467, United States

Location

Texas Tech University Health Science Center

El Paso, Texas, 79905, United States

Location

Virginia Endocrinology Research SC

Chesapeake, Virginia, 23321, United States

Location

Novartis Investigative Site

Bruges, Belgium, 8310, Belgium

Location

Novartis Investigative Site

Brussels, 1200, Belgium

Location

Novartis Investigative Site

Ghent, 9000, Belgium

Location

Novartis Investigative Site

Leuven, 3000, Belgium

Location

Novartis Investigative Site

Paris, 75651, France

Location

Novartis Investigative Site

Pessac, 33604, France

Location

Novartis Investigative Site

Pierre-Bénite, 69495, France

Location

Novartis Investigative Site

Hamburg, 20246, Germany

Location

Novartis Investigative Site

Würzburg, 97080, Germany

Location

Novartis Investigative Site

Utrecht, Netherlands, 3584CX, Netherlands

Location

Novartis Investigative Site

Groningen, 9713 GZ, Netherlands

Location

MeSH Terms

Conditions

Dumping Syndrome

Interventions

pasireotide

Condition Hierarchy (Ancestors)

Postgastrectomy Syndromes; Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

All safety parameters were analyzed by study phase (sc/LAR)

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

trialandresults.registries@novartis.com

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 9, 2012
• First Posted: July 11, 2012
• Study Start: January 8, 2013
• Primary Completion: August 7, 2015
• Study Completion: August 7, 2015
• Last Updated: May 10, 2017
• Results First Posted: May 10, 2017

Record last verified: 2017-03

Locations

NL (2); US (6); FR (3); BE (4); DE (2)