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

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ClinicalTrials.gov Identifier: NCT00994110
Recruitment Status : Completed
First Posted : October 14, 2009
Results First Posted : February 1, 2016
Last Update Posted : February 1, 2016
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition Pancreatic Cancer
Interventions Drug: Pasireotide (SOM230)
Other: placebo
Enrollment 439
Recruitment Details  
Pre-assignment Details  
Arm/Group Title SOM230 Placebo
Hide Arm/Group Description This is a randomized, double-blind, placebo controlled phase III trial of SOM230 vs. saline placebo in patients undergoing pancreaticoduodenectomy or distal pancreatectomy with or without splenectomy at MSKCC. Pasireotide (SOM230): Patients will receive subcutaneous injection of SOM230 or placebo (NS, equivalent volume) on the day of operation prior to resection in the pre-surgical center. The initial subcutaneous injection of drug or placebo will be given at least one hour prior but no longer than 8 hours prior to transection of the pancreas. Patients will be continuously monitored in the OR following this dose administration, and both their cardiac and respiratory status will be closely followed. Postoperatively patients will receive study drug or placebo every 12 hours. Subcutaneous injections will continue until postoperative day 7, with the last dose administered in the evening on postoperative day 6, or until a pancreatic complication has been identified.

This is a randomized, double-blind, placebo controlled phase III trial of SOM230 vs. saline placebo in patients undergoing pancreaticoduodenectomy or distal pancreatectomy with or without splenectomy at MSKCC. Patients will receive subcutaneous injection of SOM230 or placebo (NS, equivalent volume) on the day of operation prior to resection in the pre-surgical center. The initial subcutaneous injection of drug or placebo will be given at least one hour prior but no longer than 8 hours prior to transection of the pancreas. Patients will be continuously monitored in the OR following this dose administration, and both their cardiac and respiratory status will be closely followed.

Postoperatively patients will receive study drug or placebo every 12 hours. Subcutaneous injections will continue until postoperative day 7, with the last dose administered in the evening on postoperative day 6, or until a pancreatic complication has been identified.

Period Title: Overall Study
Started 217 222
Completed 152 148
Not Completed 65 74
Reason Not Completed
Withdrawal by Subject             9             9
Not Treated             4             8
Adverse Event             1             0
Patient not resected             41             52
Pt not eligible             10             5
Arm/Group Title SOM230 Placebo Total
Hide Arm/Group Description This is a randomized, double-blind, placebo controlled phase III trial of SOM230 vs. saline placebo in patients undergoing pancreaticoduodenectomy or distal pancreatectomy with or without splenectomy at MSKCC. Pasireotide (SOM230): Patients will receive subcutaneous injection of SOM230 or placebo (NS, equivalent volume) on the day of operation prior to resection in the pre-surgical center. The initial subcutaneous injection of drug or placebo will be given at least one hour prior but no longer than 8 hours prior to transection of the pancreas. Patients will be continuously monitored in the OR following this dose administration, and both their cardiac and respiratory status will be closely followed. Postoperatively patients will receive study drug or placebo every 12 hours. Subcutaneous injections will continue until postoperative day 7, with the last dose administered in the evening on postoperative day 6, or until a pancreatic complication has been identified.

This is a randomized, double-blind, placebo controlled phase III trial of SOM230 vs. saline placebo in patients undergoing pancreaticoduodenectomy or distal pancreatectomy with or without splenectomy at MSKCC. Patients will receive subcutaneous injection of SOM230 or placebo (NS, equivalent volume) on the day of operation prior to resection in the pre-surgical center. The initial subcutaneous injection of drug or placebo will be given at least one hour prior but no longer than 8 hours prior to transection of the pancreas. Patients will be continuously monitored in the OR following this dose administration, and both their cardiac and respiratory status will be closely followed.

Postoperatively patients will receive study drug or placebo every 12 hours. Subcutaneous injections will continue until postoperative day 7, with the last dose administered in the evening on postoperative day 6, or until a pancreatic complication has been identified.

Total of all reporting groups
Overall Number of Baseline Participants 217 222 439
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 217 participants 222 participants 439 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
107
  49.3%
104
  46.8%
211
  48.1%
>=65 years
110
  50.7%
118
  53.2%
228
  51.9%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 217 participants 222 participants 439 participants
Female
97
  44.7%
91
  41.0%
188
  42.8%
Male
120
  55.3%
131
  59.0%
251
  57.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 217 participants 222 participants 439 participants
217 222 439
1.Primary Outcome
Title 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.
Hide Description [Not Specified]
Time Frame 60 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title SOM230 Placebo
Hide Arm/Group Description:
This is a randomized, double-blind, placebo controlled phase III trial of SOM230 vs. saline placebo in patients undergoing pancreaticoduodenectomy or distal pancreatectomy with or without splenectomy at MSKCC. Pasireotide (SOM230): Patients will receive subcutaneous injection of SOM230 or placebo (NS, equivalent volume) on the day of operation prior to resection in the pre-surgical center. The initial subcutaneous injection of drug or placebo will be given at least one hour prior but no longer than 8 hours prior to transection of the pancreas. Patients will be continuously monitored in the OR following this dose administration, and both their cardiac and respiratory status will be closely followed. Postoperatively patients will receive study drug or placebo every 12 hours. Subcutaneous injections will continue until postoperative day 7, with the last dose administered in the evening on postoperative day 6, or until a pancreatic complication has been identified.

This is a randomized, double-blind, placebo controlled phase III trial of SOM230 vs. saline placebo in patients undergoing pancreaticoduodenectomy or distal pancreatectomy with or without splenectomy at MSKCC. Patients will receive subcutaneous injection of SOM230 or placebo (NS, equivalent volume) on the day of operation prior to resection in the pre-surgical center. The initial subcutaneous injection of drug or placebo will be given at least one hour prior but no longer than 8 hours prior to transection of the pancreas. Patients will be continuously monitored in the OR following this dose administration, and both their cardiac and respiratory status will be closely followed.

Postoperatively patients will receive study drug or placebo every 12 hours. Subcutaneous injections will continue until postoperative day 7, with the last dose administered in the evening on postoperative day 6, or until a pancreatic complication has been identified.

Overall Number of Participants Analyzed 150 149
Measure Type: Number
Unit of Measure: percentage of participants
9 21
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title SOM230 Placebo
Hide Arm/Group Description This is a randomized, double-blind, placebo controlled phase III trial of SOM230 vs. saline placebo in patients undergoing pancreaticoduodenectomy or distal pancreatectomy with or without splenectomy at MSKCC. Pasireotide (SOM230): Patients will receive subcutaneous injection of SOM230 or placebo (NS, equivalent volume) on the day of operation prior to resection in the pre-surgical center. The initial subcutaneous injection of drug or placebo will be given at least one hour prior but no longer than 8 hours prior to transection of the pancreas. Patients will be continuously monitored in the OR following this dose administration, and both their cardiac and respiratory status will be closely followed. Postoperatively patients will receive study drug or placebo every 12 hours. Subcutaneous injections will continue until postoperative day 7, with the last dose administered in the evening on postoperative day 6, or until a pancreatic complication has been identified.

This is a randomized, double-blind, placebo controlled phase III trial of SOM230 vs. saline placebo in patients undergoing pancreaticoduodenectomy or distal pancreatectomy with or without splenectomy at MSKCC. Patients will receive subcutaneous injection of SOM230 or placebo (NS, equivalent volume) on the day of operation prior to resection in the pre-surgical center. The initial subcutaneous injection of drug or placebo will be given at least one hour prior but no longer than 8 hours prior to transection of the pancreas. Patients will be continuously monitored in the OR following this dose administration, and both their cardiac and respiratory status will be closely followed.

Postoperatively patients will receive study drug or placebo every 12 hours. Subcutaneous injections will continue until postoperative day 7, with the last dose administered in the evening on postoperative day 6, or until a pancreatic complication has been identified.

All-Cause Mortality
SOM230 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
SOM230 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   138/217 (63.59%)      218/222 (98.20%)    
Blood and lymphatic system disorders     
Anemia  1  11/217 (5.07%)  11 11/222 (4.95%)  11
Febrile neutropenia  1  1/217 (0.46%)  1 0/222 (0.00%)  0
Cardiac disorders     
Conduction disorder  1  1/217 (0.46%)  1 0/222 (0.00%)  0
Myocardial infarction  1  2/217 (0.92%)  2 1/222 (0.45%)  1
Sinus bradycardia  1  2/217 (0.92%)  2 1/222 (0.45%)  1
Sinus tachycardia  1  1/217 (0.46%)  1 0/222 (0.00%)  0
Supraventricular tachycardia  1  1/217 (0.46%)  1 1/222 (0.45%)  1
Ventricular tachycardia  1  1/217 (0.46%)  1 0/222 (0.00%)  0
Acute coronary syndrome  1  0/217 (0.00%)  0 1/222 (0.45%)  1
Atrial fibrillation  1  0/217 (0.00%)  0 1/222 (0.45%)  1
Cardiac arrest  1  0/217 (0.00%)  0 1/222 (0.45%)  1
Gastrointestinal disorders     
Abdominal pain  1  6/217 (2.76%)  6 4/222 (1.80%)  4
Ascites  1  12/217 (5.53%)  12 19/222 (8.56%)  20
Colonic obstruction  1  1/217 (0.46%)  1 0/222 (0.00%)  0
Duodenal stenosis  1  1/217 (0.46%)  1 0/222 (0.00%)  0
Gastric hemorrhage  1  1/217 (0.46%)  1 1/222 (0.45%)  2
Gastric ulcer  1  1/217 (0.46%)  1 0/222 (0.00%)  0
Gastroparesis  1  2/217 (0.92%)  2 3/222 (1.35%)  3
Ileus  1  4/217 (1.84%)  4 3/222 (1.35%)  3
Intra-abdominal hemorrhage  1  5/217 (2.30%)  5 4/222 (1.80%)  4
Lower gastrointestinal hemorrhage  1  1/217 (0.46%)  1 1/222 (0.45%)  1
Nausea  1  5/217 (2.30%)  5 5/222 (2.25%)  5
Obstruction gastric  1  1/217 (0.46%)  1 0/222 (0.00%)  0
Pancreatic fistula  1  1/217 (0.46%)  1 3/222 (1.35%)  3
Upper gastrointestinal hemorrhage  1  3/217 (1.38%)  3 1/222 (0.45%)  1
Vomiting  1  2/217 (0.92%)  2 2/222 (0.90%)  2
Pancreatitis  1  0/217 (0.00%)  0 2/222 (0.90%)  2
Colitis  1  0/217 (0.00%)  0 1/222 (0.45%)  1
Constipation  1  0/217 (0.00%)  0 1/222 (0.45%)  1
Diarrhea  1  0/217 (0.00%)  0 3/222 (1.35%)  3
Esophagitis  1  0/217 (0.00%)  0 1/222 (0.45%)  1
General disorders     
Death NOS  1  3/217 (1.38%)  3 0/222 (0.00%)  0
Multi-organ failure  1  1/217 (0.46%)  1 0/222 (0.00%)  0
Hepatobiliary disorders     
Bile duct stenosis  1  2/217 (0.92%)  2 1/222 (0.45%)  2
Biliary fistula  1  1/217 (0.46%)  1 0/222 (0.00%)  0
Hepatic failure  1  1/217 (0.46%)  1 0/222 (0.00%)  0
Portal vein thrombosis  1  1/217 (0.46%)  1 1/222 (0.45%)  1
Infections and infestations     
Abdominal infection  1  2/217 (0.92%)  2 2/222 (0.90%)  2
Appendicitis perforated  1  1/217 (0.46%)  1 0/222 (0.00%)  0
Biliary tract infection  1  1/217 (0.46%)  1 1/222 (0.45%)  2
Catheter related infection  1  1/217 (0.46%)  1 0/222 (0.00%)  0
Device related infection  1  1/217 (0.46%)  1 2/222 (0.90%)  2
Infections and infestations - Other, specify  1  1/217 (0.46%)  1 1/222 (0.45%)  1
Lung infection  1  8/217 (3.69%)  8 4/222 (1.80%)  4
Sepsis  1  4/217 (1.84%)  4 2/222 (0.90%)  3
Skin infection  1  1/217 (0.46%)  1 0/222 (0.00%)  0
Upper respiratory infection  1  1/217 (0.46%)  1 0/222 (0.00%)  0
Urinary tract infection  1  5/217 (2.30%)  5 6/222 (2.70%)  6
Wound infection  1  7/217 (3.23%)  7 23/222 (10.36%)  23
Injury, poisoning and procedural complications     
Biliary anastomotic leak  1  3/217 (1.38%)  3 6/222 (2.70%)  6
Fall  1  1/217 (0.46%)  1 1/222 (0.45%)  1
Pancreatic anastomotic leak  1  13/217 (5.99%)  13 20/222 (9.01%)  20
Postoperative hemorrhage  1  2/217 (0.92%)  2 1/222 (0.45%)  1
Wound dehiscence  1  1/217 (0.46%)  1 1/222 (0.45%)  1
Small intestinal anastomotic leak  1  0/217 (0.00%)  0 1/222 (0.45%)  1
Gastric anastomotic leak  1  0/217 (0.00%)  0 1/222 (0.45%)  1
Investigations     
Alkaline phosphatase increased  1  1/217 (0.46%)  1 0/222 (0.00%)  0
Blood bilirubin increased  1  5/217 (2.30%)  5 2/222 (0.90%)  2
Electrocardiogram QT corrected interval prolonged  1  2/217 (0.92%)  2 2/222 (0.90%)  2
Lipase increased  1  4/217 (1.84%)  6 3/222 (1.35%)  3
Neutrophil count decreased  1  1/217 (0.46%)  1 0/222 (0.00%)  0
Serum amylase increased  1  49/217 (22.58%)  49 36/222 (16.22%)  36
Urine output decreased  1  1/217 (0.46%)  1 0/222 (0.00%)  0
White blood cell decreased  1  1/217 (0.46%)  1 0/222 (0.00%)  0
Activated partial thromboplastin time prolonged  1  0/217 (0.00%)  0 1/222 (0.45%)  1
Alanine aminotransferase increased  1  0/217 (0.00%)  0 1/222 (0.45%)  1
Aspartate aminotransferase increase  1  0/217 (0.00%)  0 1/222 (0.45%)  1
INR increase  1  0/217 (0.00%)  0 1/222 (0.45%)  1
Lymphocyte count decreased  1  0/217 (0.00%)  0 1/222 (0.45%)  1
Metabolism and nutrition disorders     
Acidosis  1  1/217 (0.46%)  1 0/222 (0.00%)  0
Anorexia  1  1/217 (0.46%)  1 5/222 (2.25%)  5
Dehydration  1  3/217 (1.38%)  3 4/222 (1.80%)  4
Hypercalcemia  1  1/217 (0.46%)  1 0/222 (0.00%)  0
Hyperglycemia  1  89/217 (41.01%)  90 54/222 (24.32%)  55
Hyperkalemia  1  2/217 (0.92%)  2 0/222 (0.00%)  0
Hypermagnesemia  1  1/217 (0.46%)  1 2/222 (0.90%)  2
Hypoalbuminemia  1  1/217 (0.46%)  1 3/222 (1.35%)  3
Hypoglycemia  1  4/217 (1.84%)  4 2/222 (0.90%)  2
Hyponatremia  1  1/217 (0.46%)  1 0/222 (0.00%)  0
Dehydration  1  0/217 (0.00%)  0 4/222 (1.80%)  4
Hypocalcemia  1  0/217 (0.00%)  0 2/222 (0.90%)  2
Hypokalemia  1  0/217 (0.00%)  0 1/222 (0.45%)  1
Hypophosphatemia  1  0/217 (0.00%)  0 4/222 (1.80%)  4
Nervous system disorders     
Headache  1  1/217 (0.46%)  1 1/222 (0.45%)  1
Peripheral motor neuropathy  1  2/217 (0.92%)  2 0/222 (0.00%)  0
Syncope  1  1/217 (0.46%)  1 0/222 (0.00%)  0
Vasovagal reaction  1  1/217 (0.46%)  1 1/222 (0.45%)  1
Psychiatric disorders     
Delirium  1  0/217 (0.00%)  0 1/222 (0.45%)  1
Renal and urinary disorders     
Acute kidney injury  1  1/217 (0.46%)  1 1/222 (0.45%)  1
Chronic kidney disease  1  0/217 (0.00%)  0 1/222 (0.45%)  1
Respiratory, thoracic and mediastinal disorders     
Adult respiratory distress syndrome  1  1/217 (0.46%)  1 0/222 (0.00%)  0
Aspiration  1  1/217 (0.46%)  1 0/222 (0.00%)  0
Bronchial obstruction  1  1/217 (0.46%)  1 0/222 (0.00%)  0
Pleural effusion  1  2/217 (0.92%)  2 4/222 (1.80%)  4
Respiratory failure  1  2/217 (0.92%)  2 2/222 (0.90%)  2
Vascular disorders     
Hot flashes  1  1/217 (0.46%)  1 0/222 (0.00%)  0
Hypotension  1  2/217 (0.92%)  2 1/222 (0.45%)  1
Thromboembolic event  1  5/217 (2.30%)  5 7/222 (3.15%)  7
Hematoma  1  0/217 (0.00%)  0 4/222 (1.80%)  4
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
SOM230 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   152/217 (70.05%)      150/222 (67.57%)    
Cardiac disorders     
Atrial fibrillation  1  11/217 (5.07%)  13 9/222 (4.05%)  10
Gastrointestinal disorders     
Abdominal pain  1  8/217 (3.69%)  8 11/222 (4.95%)  12
Ascites  1  16/217 (7.37%)  16 26/222 (11.71%)  29
Nausea  1  10/217 (4.61%)  11 13/222 (5.86%)  13
Infections and infestations     
Wound infection  1  17/217 (7.83%)  17 26/222 (11.71%)  27
Injury, poisoning and procedural complications     
Pancreatic anastomotic leak  1  13/217 (5.99%)  13 22/222 (9.91%)  22
Investigations     
Alanine aminotransferase increased  1  47/217 (21.66%)  181 54/222 (24.32%)  197
Alkaline phosphatase increased  1  22/217 (10.14%)  107 23/222 (10.36%)  186
Aspartate aminotransferase increased  1  47/217 (21.66%)  98 53/222 (23.87%)  122
Blood bilirubin increased  1  50/217 (23.04%)  259 56/222 (25.23%)  243
INR increased  1  15/217 (6.91%)  41 9/222 (4.05%)  18
Lymphocyte count decreased  1  56/217 (25.81%)  160 56/222 (25.23%)  145
Neutrophil count decreased  1  29/217 (13.36%)  44 33/222 (14.86%)  73
Serum amylase increased  1  59/217 (27.19%)  134 54/222 (24.32%)  110
White blood cell decreased  1  24/217 (11.06%)  114 27/222 (12.16%)  115
Metabolism and nutrition disorders     
Hyperglycemia  1  147/217 (67.74%)  1010 130/222 (58.56%)  746
Hyperkalemia  1  12/217 (5.53%)  16 13/222 (5.86%)  17
Hypoalbuminemia  1  66/217 (30.41%)  325 58/222 (26.13%)  416
Hypocalcemia  1  123/217 (56.68%)  756 125/222 (56.31%)  849
Hypoglycemia  1  11/217 (5.07%)  18 7/222 (3.15%)  8
Hypophosphatemia  1  123/217 (56.68%)  271 98/222 (44.14%)  265
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Peter Allen
Organization: Memorial Sloan Kettering Cancer Center
Phone: 212-639-5132
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00994110     History of Changes
Other Study ID Numbers: 09-039
First Submitted: October 13, 2009
First Posted: October 14, 2009
Results First Submitted: December 22, 2015
Results First Posted: February 1, 2016
Last Update Posted: February 1, 2016