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Prospective Randomized, Double Blind, Placebo Controlled Trial of SOM230 for the Reduction of Post-Pancreatectomy Fistula, Leak, and Abscess

Phase 3
18 Years
Open (Enrolling)
Pancreatic Cancer

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Trial Information

Prospective Randomized, Double Blind, Placebo Controlled Trial of SOM230 for the Reduction of Post-Pancreatectomy Fistula, Leak, and Abscess

Inclusion Criteria:

- Male or female patients aged 18 years or greater.

- Signed informed consent

- Candidate for pancreaticoduodenectomy or distal pancreatectomy with or without

Exclusion Criteria:

- Pregnancy

- Patients with malabsorption syndrome, short bowel or chologenic diarrhea not
controlled by specific therapeutic means.

- Patients with uncontrolled diabetes mellitus or a fasting plasma glucose > 250mg/dl.

Note: At the principle investigator's discretion, non-eligible patients can be re-screened
after adequate medical therapy has been instituted.

- Patients who have congestive heart failure (NYHA Class III or IV), unstable angina,
sustained ventricular tachycardia, ventricular fibrillation, clinically significant
bradycardia, advanced heart block or a history of acute myocardial infarction within
the six months preceding enrollment.

- Patients who are at risk for QT prolongation. Risk factors include: patients with
electrolyte disturbances such as hypokalemia, hypomagnesemia, and hypocalcemia;
patients with a family history of long QT syndrome. syncope, and idiopathic sudden
death; patients with concomitant diseases that could prolong QT such as autonomic
neuropathy (caused by diabetes, or Parkinson's disease), HIV, cirrhosis, uncontrolled
hypothyroidism, bradycardia, high-grade AV block, significant cardiac arrhythmias, or
cardiac failure; patients using concomitant medications known to prolong the QT
interval while receiving protocol treatment. These medications include selected
antiarrhythmics, antihistamines, macrolide antibiotics, and /or tricyclic
antidepressants as follows:

Albuterol Alfuzosin Amantadine Amiodarone Amitriptyline Amphetamine Arsenic Trioxide
Astemizole Atazanavir Atomoxetine Azithromycin Chloroquine Clomipramine Dolasetron
Metaproterenol Moxifloxacin Phenermine Phenylpropanolamine

- Those drugs not specifically listed above but possibly suspected of causing QT
prolongation would not necessarily preclude patient registration, but would be
discussed with the attending physician prior to initiation of protocol therapy.

- Patients with QTc >450 msec.

- Patients with liver disease such as cirrhosis, chronic active hepatitis or chronic
persistent hepatitis.

- Patients with acute cholecystitis

- Patients with the presence of active or suspected acute or chronic uncontrolled
infection or with a history of immunocompromise, including a positive HIV test result
(ELISA and Western blot).

- Patients with abnormal coagulation (INR>1.5) or patients receiving anticoagulants
that affect PT (prothrombin time) or APTT ( activated thromboplastin time)

- Patients with WBC <3 K/mcL; PLT < 100 K/mcL

- Patients who have any current or prior medical condition that may interfere with the
conduct of the study or the evaluation of its results in the opinion of the

- Patients who have participated in any clinical investigation with an investigational
drug (other then pasireotide) within 30 days prior to dosing.

- Known hypersensitivity to somatostatin analogues or any component of the pasireotide
or octreotide LAR or s.c. formulations

- 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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

To compare 60-day ≥grade 3 pancreatic complication rates (fistula, leak, and abscess) as defined by the MSKCC surgical secondary events system between patients who receive perioperative SOM230 and saline placebo.

Outcome Time Frame:

60 days

Safety Issue:


Principal Investigator

Peter Allen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

October 2009

Completion Date:

October 2014

Related Keywords:

  • Pancreatic Cancer
  • Pasireotide
  • SOM230
  • saline placebo
  • 09-039
  • Pancreatic Neoplasms



Memorial Sloan Kettering Cancer CenterNew York, New York  10021