Trial Outcomes & Findings for Placebo Controlled Trial of SOM230 for the Reduction of Post-Pancreatectomy Fistula, Leak, and Abscess (NCT NCT00994110)
NCT ID: NCT00994110
Last Updated: 2016-02-01
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
439 participants
Primary outcome timeframe
60 days
Results posted on
2016-02-01
Participant Flow
Participant milestones
| Measure |
SOM230
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.
|
Placebo
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 Study
STARTED
|
217
|
222
|
|
Overall Study
COMPLETED
|
152
|
148
|
|
Overall Study
NOT COMPLETED
|
65
|
74
|
Reasons for withdrawal
| Measure |
SOM230
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.
|
Placebo
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 Study
Withdrawal by Subject
|
9
|
9
|
|
Overall Study
Not Treated
|
4
|
8
|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Patient not resected
|
41
|
52
|
|
Overall Study
Pt not eligible
|
10
|
5
|
Baseline Characteristics
Placebo Controlled Trial of SOM230 for the Reduction of Post-Pancreatectomy Fistula, Leak, and Abscess
Baseline characteristics by cohort
| Measure |
SOM230
n=217 Participants
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.
|
Placebo
n=222 Participants
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
n=439 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
107 Participants
n=5 Participants
|
104 Participants
n=7 Participants
|
211 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
110 Participants
n=5 Participants
|
118 Participants
n=7 Participants
|
228 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
97 Participants
n=5 Participants
|
91 Participants
n=7 Participants
|
188 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
120 Participants
n=5 Participants
|
131 Participants
n=7 Participants
|
251 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
217 participants
n=5 Participants
|
222 participants
n=7 Participants
|
439 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 60 daysOutcome measures
| Measure |
SOM230
n=150 Participants
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.
|
Placebo
n=149 Participants
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.
|
|---|---|---|
|
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.
|
9 percentage of participants
|
21 percentage of participants
|
Adverse Events
SOM230
Serious events: 138 serious events
Other events: 152 other events
Deaths: 0 deaths
Placebo
Serious events: 218 serious events
Other events: 150 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SOM230
n=217 participants at risk
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.
|
Placebo
n=222 participants at risk
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.
|
|---|---|---|
|
Infections and infestations
Abdominal infection
|
0.92%
2/217 • Number of events 2
|
0.90%
2/222 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal pain
|
2.8%
6/217 • Number of events 6
|
1.8%
4/222 • Number of events 4
|
|
Metabolism and nutrition disorders
Acidosis
|
0.46%
1/217 • Number of events 1
|
0.00%
0/222
|
|
Renal and urinary disorders
Acute kidney injury
|
0.46%
1/217 • Number of events 1
|
0.45%
1/222 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Adult respiratory distress syndrome
|
0.46%
1/217 • Number of events 1
|
0.00%
0/222
|
|
Investigations
Alkaline phosphatase increased
|
0.46%
1/217 • Number of events 1
|
0.00%
0/222
|
|
Blood and lymphatic system disorders
Anemia
|
5.1%
11/217 • Number of events 11
|
5.0%
11/222 • Number of events 11
|
|
Metabolism and nutrition disorders
Anorexia
|
0.46%
1/217 • Number of events 1
|
2.3%
5/222 • Number of events 5
|
|
Infections and infestations
Appendicitis perforated
|
0.46%
1/217 • Number of events 1
|
0.00%
0/222
|
|
Gastrointestinal disorders
Ascites
|
5.5%
12/217 • Number of events 12
|
8.6%
19/222 • Number of events 20
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.46%
1/217 • Number of events 1
|
0.00%
0/222
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.92%
2/217 • Number of events 2
|
0.45%
1/222 • Number of events 2
|
|
Injury, poisoning and procedural complications
Biliary anastomotic leak
|
1.4%
3/217 • Number of events 3
|
2.7%
6/222 • Number of events 6
|
|
Hepatobiliary disorders
Biliary fistula
|
0.46%
1/217 • Number of events 1
|
0.00%
0/222
|
|
Infections and infestations
Biliary tract infection
|
0.46%
1/217 • Number of events 1
|
0.45%
1/222 • Number of events 2
|
|
Investigations
Blood bilirubin increased
|
2.3%
5/217 • Number of events 5
|
0.90%
2/222 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.46%
1/217 • Number of events 1
|
0.00%
0/222
|
|
Infections and infestations
Catheter related infection
|
0.46%
1/217 • Number of events 1
|
0.00%
0/222
|
|
Gastrointestinal disorders
Colonic obstruction
|
0.46%
1/217 • Number of events 1
|
0.00%
0/222
|
|
Cardiac disorders
Conduction disorder
|
0.46%
1/217 • Number of events 1
|
0.00%
0/222
|
|
General disorders
Death NOS
|
1.4%
3/217 • Number of events 3
|
0.00%
0/222
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/217
|
1.8%
4/222 • Number of events 4
|
|
Infections and infestations
Device related infection
|
0.46%
1/217 • Number of events 1
|
0.90%
2/222 • Number of events 2
|
|
Gastrointestinal disorders
Duodenal stenosis
|
0.46%
1/217 • Number of events 1
|
0.00%
0/222
|
|
Investigations
Electrocardiogram QT corrected interval prolonged
|
0.92%
2/217 • Number of events 2
|
0.90%
2/222 • Number of events 2
|
|
Injury, poisoning and procedural complications
Fall
|
0.46%
1/217 • Number of events 1
|
0.45%
1/222 • Number of events 1
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.46%
1/217 • Number of events 1
|
0.00%
0/222
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
0.46%
1/217 • Number of events 1
|
0.45%
1/222 • Number of events 2
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.46%
1/217 • Number of events 1
|
0.00%
0/222
|
|
Gastrointestinal disorders
Gastroparesis
|
0.92%
2/217 • Number of events 2
|
1.4%
3/222 • Number of events 3
|
|
Nervous system disorders
Headache
|
0.46%
1/217 • Number of events 1
|
0.45%
1/222 • Number of events 1
|
|
Hepatobiliary disorders
Hepatic failure
|
0.46%
1/217 • Number of events 1
|
0.00%
0/222
|
|
Vascular disorders
Hot flashes
|
0.46%
1/217 • Number of events 1
|
0.00%
0/222
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
0.46%
1/217 • Number of events 1
|
0.00%
0/222
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
41.0%
89/217 • Number of events 90
|
24.3%
54/222 • Number of events 55
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.92%
2/217 • Number of events 2
|
0.00%
0/222
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
0.46%
1/217 • Number of events 1
|
0.90%
2/222 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.46%
1/217 • Number of events 1
|
1.4%
3/222 • Number of events 3
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
1.8%
4/217 • Number of events 4
|
0.90%
2/222 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.46%
1/217 • Number of events 1
|
0.00%
0/222
|
|
Vascular disorders
Hypotension
|
0.92%
2/217 • Number of events 2
|
0.45%
1/222 • Number of events 1
|
|
Gastrointestinal disorders
Ileus
|
1.8%
4/217 • Number of events 4
|
1.4%
3/222 • Number of events 3
|
|
Infections and infestations
Infections and infestations - Other, specify
|
0.46%
1/217 • Number of events 1
|
0.45%
1/222 • Number of events 1
|
|
Gastrointestinal disorders
Intra-abdominal hemorrhage
|
2.3%
5/217 • Number of events 5
|
1.8%
4/222 • Number of events 4
|
|
Investigations
Lipase increased
|
1.8%
4/217 • Number of events 6
|
1.4%
3/222 • Number of events 3
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
0.46%
1/217 • Number of events 1
|
0.45%
1/222 • Number of events 1
|
|
Infections and infestations
Lung infection
|
3.7%
8/217 • Number of events 8
|
1.8%
4/222 • Number of events 4
|
|
General disorders
Multi-organ failure
|
0.46%
1/217 • Number of events 1
|
0.00%
0/222
|
|
Cardiac disorders
Myocardial infarction
|
0.92%
2/217 • Number of events 2
|
0.45%
1/222 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
2.3%
5/217 • Number of events 5
|
2.3%
5/222 • Number of events 5
|
|
Investigations
Neutrophil count decreased
|
0.46%
1/217 • Number of events 1
|
0.00%
0/222
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.46%
1/217 • Number of events 1
|
0.00%
0/222
|
|
Injury, poisoning and procedural complications
Pancreatic anastomotic leak
|
6.0%
13/217 • Number of events 13
|
9.0%
20/222 • Number of events 20
|
|
Gastrointestinal disorders
Pancreatic fistula
|
0.46%
1/217 • Number of events 1
|
1.4%
3/222 • Number of events 3
|
|
Nervous system disorders
Peripheral motor neuropathy
|
0.92%
2/217 • Number of events 2
|
0.00%
0/222
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.92%
2/217 • Number of events 2
|
1.8%
4/222 • Number of events 4
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.46%
1/217 • Number of events 1
|
0.45%
1/222 • Number of events 1
|
|
Injury, poisoning and procedural complications
Postoperative hemorrhage
|
0.92%
2/217 • Number of events 2
|
0.45%
1/222 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.92%
2/217 • Number of events 2
|
0.90%
2/222 • Number of events 2
|
|
Infections and infestations
Sepsis
|
1.8%
4/217 • Number of events 4
|
0.90%
2/222 • Number of events 3
|
|
Investigations
Serum amylase increased
|
22.6%
49/217 • Number of events 49
|
16.2%
36/222 • Number of events 36
|
|
Cardiac disorders
Sinus bradycardia
|
0.92%
2/217 • Number of events 2
|
0.45%
1/222 • Number of events 1
|
|
Cardiac disorders
Sinus tachycardia
|
0.46%
1/217 • Number of events 1
|
0.00%
0/222
|
|
Infections and infestations
Skin infection
|
0.46%
1/217 • Number of events 1
|
0.00%
0/222
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.46%
1/217 • Number of events 1
|
0.45%
1/222 • Number of events 1
|
|
Nervous system disorders
Syncope
|
0.46%
1/217 • Number of events 1
|
0.00%
0/222
|
|
Vascular disorders
Thromboembolic event
|
2.3%
5/217 • Number of events 5
|
3.2%
7/222 • Number of events 7
|
|
Gastrointestinal disorders
Upper gastrointestinal hemorrhage
|
1.4%
3/217 • Number of events 3
|
0.45%
1/222 • Number of events 1
|
|
Infections and infestations
Upper respiratory infection
|
0.46%
1/217 • Number of events 1
|
0.00%
0/222
|
|
Infections and infestations
Urinary tract infection
|
2.3%
5/217 • Number of events 5
|
2.7%
6/222 • Number of events 6
|
|
Investigations
Urine output decreased
|
0.46%
1/217 • Number of events 1
|
0.00%
0/222
|
|
Nervous system disorders
Vasovagal reaction
|
0.46%
1/217 • Number of events 1
|
0.45%
1/222 • Number of events 1
|
|
Cardiac disorders
Ventricular tachycardia
|
0.46%
1/217 • Number of events 1
|
0.00%
0/222
|
|
Gastrointestinal disorders
Vomiting
|
0.92%
2/217 • Number of events 2
|
0.90%
2/222 • Number of events 2
|
|
Investigations
White blood cell decreased
|
0.46%
1/217 • Number of events 1
|
0.00%
0/222
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.46%
1/217 • Number of events 1
|
0.45%
1/222 • Number of events 1
|
|
Infections and infestations
Wound infection
|
3.2%
7/217 • Number of events 7
|
10.4%
23/222 • Number of events 23
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/217
|
0.45%
1/222 • Number of events 1
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/217
|
0.45%
1/222 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/217
|
0.45%
1/222 • Number of events 1
|
|
Investigations
Aspartate aminotransferase increase
|
0.00%
0/217
|
0.45%
1/222 • Number of events 1
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/217
|
0.45%
1/222 • Number of events 1
|
|
Investigations
INR increase
|
0.00%
0/217
|
0.45%
1/222 • Number of events 1
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/217
|
0.90%
2/222 • Number of events 2
|
|
Injury, poisoning and procedural complications
Small intestinal anastomotic leak
|
0.00%
0/217
|
0.45%
1/222 • Number of events 1
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/217
|
0.45%
1/222 • Number of events 1
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/217
|
0.45%
1/222 • Number of events 1
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/217
|
0.45%
1/222 • Number of events 1
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/217
|
0.45%
1/222 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/217
|
0.45%
1/222 • Number of events 1
|
|
Psychiatric disorders
Delirium
|
0.00%
0/217
|
0.45%
1/222 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/217
|
1.4%
3/222 • Number of events 3
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/217
|
0.45%
1/222 • Number of events 1
|
|
Injury, poisoning and procedural complications
Gastric anastomotic leak
|
0.00%
0/217
|
0.45%
1/222 • Number of events 1
|
|
Vascular disorders
Hematoma
|
0.00%
0/217
|
1.8%
4/222 • Number of events 4
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
0.00%
0/217
|
0.90%
2/222 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypokalemia
|
0.00%
0/217
|
0.45%
1/222 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
0.00%
0/217
|
1.8%
4/222 • Number of events 4
|
Other adverse events
| Measure |
SOM230
n=217 participants at risk
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.
|
Placebo
n=222 participants at risk
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.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
3.7%
8/217 • Number of events 8
|
5.0%
11/222 • Number of events 12
|
|
Investigations
Alanine aminotransferase increased
|
21.7%
47/217 • Number of events 181
|
24.3%
54/222 • Number of events 197
|
|
Investigations
Alkaline phosphatase increased
|
10.1%
22/217 • Number of events 107
|
10.4%
23/222 • Number of events 186
|
|
Gastrointestinal disorders
Ascites
|
7.4%
16/217 • Number of events 16
|
11.7%
26/222 • Number of events 29
|
|
Investigations
Aspartate aminotransferase increased
|
21.7%
47/217 • Number of events 98
|
23.9%
53/222 • Number of events 122
|
|
Cardiac disorders
Atrial fibrillation
|
5.1%
11/217 • Number of events 13
|
4.1%
9/222 • Number of events 10
|
|
Investigations
Blood bilirubin increased
|
23.0%
50/217 • Number of events 259
|
25.2%
56/222 • Number of events 243
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
67.7%
147/217 • Number of events 1010
|
58.6%
130/222 • Number of events 746
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
5.5%
12/217 • Number of events 16
|
5.9%
13/222 • Number of events 17
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
30.4%
66/217 • Number of events 325
|
26.1%
58/222 • Number of events 416
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
56.7%
123/217 • Number of events 756
|
56.3%
125/222 • Number of events 849
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
5.1%
11/217 • Number of events 18
|
3.2%
7/222 • Number of events 8
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
56.7%
123/217 • Number of events 271
|
44.1%
98/222 • Number of events 265
|
|
Investigations
INR increased
|
6.9%
15/217 • Number of events 41
|
4.1%
9/222 • Number of events 18
|
|
Investigations
Lymphocyte count decreased
|
25.8%
56/217 • Number of events 160
|
25.2%
56/222 • Number of events 145
|
|
Gastrointestinal disorders
Nausea
|
4.6%
10/217 • Number of events 11
|
5.9%
13/222 • Number of events 13
|
|
Investigations
Neutrophil count decreased
|
13.4%
29/217 • Number of events 44
|
14.9%
33/222 • Number of events 73
|
|
Injury, poisoning and procedural complications
Pancreatic anastomotic leak
|
6.0%
13/217 • Number of events 13
|
9.9%
22/222 • Number of events 22
|
|
Investigations
Serum amylase increased
|
27.2%
59/217 • Number of events 134
|
24.3%
54/222 • Number of events 110
|
|
Investigations
White blood cell decreased
|
11.1%
24/217 • Number of events 114
|
12.2%
27/222 • Number of events 115
|
|
Infections and infestations
Wound infection
|
7.8%
17/217 • Number of events 17
|
11.7%
26/222 • Number of events 27
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place