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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

Phase 2
18 Years
Open (Enrolling)
Dumping Syndrome Patients

Thank you

Trial Information

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

43 adult dumping syndrome patients will receive 3 months of pasireotide s.c. and then dose
will be increased based on OGTT results. After 3months, patients will then receive either
pasireotide LAR 10 or 20. Patients will be offered to enter into the 6 month extension if
they experienced benefit with pasireotide LAR treatment

Inclusion Criteria

Inclusion criteria:.

1. Male or female patients ≥ 18 years of age

2. 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: must be disease free at study entry

- Gastric cancer surgery: must be stage 0 or I and must be disease free at study

3. 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:

1. glucose <50mg/dL on a sporadic or scheduled blood analysis -or-

2. a value <60 mg/dL at 90,120, 150 or 180 min during an OGTT

4. Patients must have at least one glucose level < 60 mg/dL at 90, 120, 150 or 180 min
during the 3-hour OGTT at screening

5. Patients with esophageal cancer must have a negative CT or MRI scan (neck, thoracic,
and upper abdominal ) and albumin ≥3.5g/dl at baseline

6. Patients with gastric cancer must have a negative CT or MRI scan (total abdomen)

7. Karnofsky Performance Status ≥ 60 (i.e. requires occasional assistance, but is able
to care for most of their personal needs)

8. Patients who received other therapies for dumping syndrome (such as acarbose, gama
guar, pectin) must have stopped all treatments and allow 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).

9. Patients able to provide and have provided signed written informed consent prior to
study participation.

Exclusion criteria:

1. Bariatric patients who have lap band.

2. Patients with a diagnosis of Diabetes Mellitus.

3. Patients who have failed treatment with somatostatin analogues for dumping syndrome
in the past

4. Patients who have been treated with somatostatin analogues in the past, must have an
appropriate interval between the last administration of somatostatin analogues
treatment and the study drug as follows

- Octreotide s.c. 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

5. Patients who have a known hypersensitivity to somatostatin analogues.

6. Patients receiving anti-cancer therapy (chemotherapy and/or radiotherapy)

7. Patients who have 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 HIV test
result (ELISA and Western blot). An HIV test will not be required; however,
previous medical history will be reviewed.

- Non-malignant medical illnesses that are uncontrolled or whose control may be
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

8. Inadequate end organ function as defined by:

- Inadequate bone marrow function:

- WBC < 2.5 x 109/L

- Absolute Neutrophil Count (ANC) < 1.5 x 109/L

- Platelets < 100 x 109/L

- Hb < 9 g/dL

- INR ≥ 1.3

- Serum creatinine >2.0 mg/dL

- Alkaline phosphatase >2.5 x ULN

- Serum total bilirubin >1.5 x ULN

- ALT and AST > 2 x ULN

9. History of liver disease, such as cirrhosis or chronic active hepatitis B and C.

10. Presence of Hepatitis B surface antigen (HbsAg) and/ orPresence of Hepatitis C
antibody test (anti-HCV)

11. History of, or current alcohol and/or drug misuse/abuse within the past 12 months

12. Patients with symptomatic cholelithiasis

13. Patients with abnormal coagulation (PT and PTT elevated by 30% above normal limits).

14. Patients on continuous anticoagulation therapy. Patients who were on anticoagulant
therapy must complete a washout period of at least 10 days and have confirmed normal
coagulation parameters before study inclusion (patients receiving aspirin once a day
are allowed to be enrolled).

15. Patients who are hypothyroid and not on adequate replacement therapy

16. Patients who have undergone major surgery/surgical therapy for any cause within 1
month. Patients should have recovered from the surgery and be in good clinical
condition before entering the study.

17. Patients who have a history of a primary malignancy (or "another" primary malignancy
for patients with gastric or esophageal cancer) within the last 1 year, with the
exception of locally excised non-melanoma skin cancer, carcinoma in situ of uterine
cervix, and excised mucosal gastric cancer or mucosal colon cancer.

18. 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.

19. Clinically significant abnormal laboratory values considered by the investigator or
the medical monitor of the sponsor to be clinically significant or which could have
affected the interpretation of the study results.

20. QT-related exclusion criteria:

- QTcF at screening > 470 msec

- History of syncope or family history of idiopathic sudden death

- Sustained or clinically significant cardiac arrhythmias

- Risk factors for Torsades de Pointes such as hypokalemia, hypomagnesemia,
cardiac failure, clinically significant/symptomatic bradycardia, or high-grade
AV block

- Concomitant disease(s) that could prolong QT such as autonomic neuropathy
(caused by diabetes, or Parkinson's disease), HIV, cirrhosis, uncontrolled
hypothyroidism or cardiac failure

- Family history of long QT syndrome

- Concomitant medications known to prolong the QT interval.

- Potassium < or = 3.5 mEq/L

- Magnesium < 0.7 mEq/L

21. Participation in any clinical investigation within 4 weeks prior to dosing or longer
if required by local regulation. (Use of an investigational drug within 1 month prior
to dosing)

22. Significant acute illness within the two weeks prior to dosing.

23. Female patients who are pregnant or lactating, or are of childbearing potential
(defined as all women physiologically capable of becoming pregnant) and not
practicing an effective method of contraception/birth control. Sexually active males
must use a condom during intercourse while taking the drug and for 2 months after the
last dose of study drug and should not father a child in this period. A condom is
required to be used also by vasectomized men in order to prevent delivery of the drug
via seminal fluid. Effective contraception methods include:

- Use of oral, injected or implanted hormonal methods of contraception or

- Placement of an intrauterine device (IUD) or intrauterine system (IUS)

- Barrier methods of contraception: condom or occlusive cap (diaphragm or
cervical/vault caps) with spermicidal foam/gel/film/cream/ vaginal suppository

- Total abstinence or patient sterilization (male or female)

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Change in response rate in plasma glucose level at the end of subcutaneous (s.c.) dose escalation phase

Outcome Description:

Response rate is defined as proportion of patients with no hypoglycemia at 90, 120, 150 and 180 minutes during oral glucose tolerance test (OGTT); dose escalation phase = month 3

Outcome Time Frame:

baseline, 3 months

Safety Issue:


Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals


France: Institutional Ethical Committee

Study ID:




Start Date:

January 2013

Completion Date:

December 2014

Related Keywords:

  • Dumping Syndrome Patients
  • Dumping syndrome
  • Dumping Syndrome



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