Pasireotide (SOM230) shows efficacy and tolerability in the treatment of patients with advanced neuroendocrine tumors refractory or resistant to octreotide LAR: results from a phase II study.

Kvols LK, Oberg KE, O'Dorisio TM, Mohideen P, de Herder WW, Arnold R, Hu K, Zhang Y, Hughes G, Anthony L, Wiedenmann B

Endocrine-related cancer14 Sept 2012Cited by 143 (Europe PMC)

PMID22807497DOI10.1530/erc-11-0367PepBankPUB-22807497

Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study8

8 results from studies that gave the peptide. 8 results from people.

01HumanNon-randomized trialSafety outcome
In advanced NET patients receiving pasireotide, drug-related nausea occurred in 27%.
In plain wordsIn patients with advanced NET receiving pasireotide, drug-related nausea occurred in 27%.
Peptide
Pasireotide
Outcome
Not applicableNausea
Study
n = 45
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
150 μg twice daily, escalated to a maximum of 1200 μg twice daily · subcutaneousAs given in this study (human).
Measurements
Drug-related nausea
27%
pasireotide, tolerability population
Source sentences
Summary
The most common drug-related adverse events were nausea (27%), abdominal pain (20%), weight loss (20%), and hyperglycemia (16%) and most were of mild or moderate severity.
3 context sentences(design, population, supporting numbers)
Summary · context
This was a phase II, open-label, multicenter study of pasireotide in patients with advanced NET whose symptoms of carcinoid syndrome (diarrhea/flushing) were inadequately controlled by octreotide LAR.
Summary · context
Patients received s.c. pasireotide 150 μg twice daily (bid), escalated to a maximum dose of 1200 μg bid until a clinical response was achieved.
Summary · context
Forty-four patients were evaluated for efficacy and 45 for tolerability.
Report a problemFND-2280749704
02HumanNon-randomized trialSafety outcome
In advanced NET patients receiving pasireotide, drug-related abdominal pain occurred in 20%.
In plain wordsIn patients with advanced NET receiving pasireotide, drug-related abdominal pain occurred in 20%.
Peptide
Pasireotide
Outcome
Not applicableAbdominal pain
Study
n = 45
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
150 μg twice daily, escalated to a maximum of 1200 μg twice daily · subcutaneousAs given in this study (human).
Measurements
Drug-related abdominal pain
20%
pasireotide, tolerability population
Source sentences
Summary
The most common drug-related adverse events were nausea (27%), abdominal pain (20%), weight loss (20%), and hyperglycemia (16%) and most were of mild or moderate severity.
3 context sentences(design, population, supporting numbers)
Summary · context
This was a phase II, open-label, multicenter study of pasireotide in patients with advanced NET whose symptoms of carcinoid syndrome (diarrhea/flushing) were inadequately controlled by octreotide LAR.
Summary · context
Patients received s.c. pasireotide 150 μg twice daily (bid), escalated to a maximum dose of 1200 μg bid until a clinical response was achieved.
Summary · context
Forty-four patients were evaluated for efficacy and 45 for tolerability.
Report a problemFND-2280749705
03HumanNon-randomized trialSafety outcome
In advanced NET patients receiving pasireotide, drug-related weight loss occurred in 20%.
In plain wordsIn patients with advanced NET receiving pasireotide, drug-related weight loss occurred in 20%.
Peptide
Pasireotide
Outcome
Not applicableWeight loss adverse event
Study
n = 45
Outcome group
Adverse events · Metabolic and weight
Studied dose
150 μg twice daily, escalated to a maximum of 1200 μg twice daily · subcutaneousAs given in this study (human).
Measurements
Drug-related weight loss
20%
pasireotide, tolerability population
Source sentences
Summary
The most common drug-related adverse events were nausea (27%), abdominal pain (20%), weight loss (20%), and hyperglycemia (16%) and most were of mild or moderate severity.
3 context sentences(design, population, supporting numbers)
Summary · context
This was a phase II, open-label, multicenter study of pasireotide in patients with advanced NET whose symptoms of carcinoid syndrome (diarrhea/flushing) were inadequately controlled by octreotide LAR.
Summary · context
Patients received s.c. pasireotide 150 μg twice daily (bid), escalated to a maximum dose of 1200 μg bid until a clinical response was achieved.
Summary · context
Forty-four patients were evaluated for efficacy and 45 for tolerability.
Report a problemFND-2280749706
04HumanNon-randomized trialSafety outcome
In advanced NET patients receiving pasireotide, drug-related hyperglycemia occurred in 16%.
In plain wordsIn patients with advanced NET receiving pasireotide, drug-related high blood sugar occurred in 16%.
Peptide
Pasireotide
Outcome
Not applicableHyperglycemia
Study
n = 45
Outcome group
Adverse events · Metabolic and weight
Studied dose
150 μg twice daily, escalated to a maximum of 1200 μg twice daily · subcutaneousAs given in this study (human).
Measurements
Drug-related hyperglycemia
16%
pasireotide, tolerability population
Source sentences
Summary
The most common drug-related adverse events were nausea (27%), abdominal pain (20%), weight loss (20%), and hyperglycemia (16%) and most were of mild or moderate severity.
3 context sentences(design, population, supporting numbers)
Summary · context
This was a phase II, open-label, multicenter study of pasireotide in patients with advanced NET whose symptoms of carcinoid syndrome (diarrhea/flushing) were inadequately controlled by octreotide LAR.
Summary · context
Patients received s.c. pasireotide 150 μg twice daily (bid), escalated to a maximum dose of 1200 μg bid until a clinical response was achieved.
Summary · context
Forty-four patients were evaluated for efficacy and 45 for tolerability.
Report a problemFND-2280749707
05HumanNon-randomized trialSafety outcome
In advanced NET patients receiving pasireotide, most common drug-related adverse events were mild or moderate.
In plain wordsIn patients with advanced NET receiving pasireotide, most common drug-related adverse events were mild or moderate.
Peptide
Pasireotide
Outcome
Not applicableAdverse event severity
Study
n = 45
Outcome group
Adverse events · Whole body
Studied dose
150 μg twice daily, escalated to a maximum of 1200 μg twice daily · subcutaneousAs given in this study (human).
Source sentences
Summary
The most common drug-related adverse events were nausea (27%), abdominal pain (20%), weight loss (20%), and hyperglycemia (16%) and most were of mild or moderate severity.
3 context sentences(design, population, supporting numbers)
Summary · context
This was a phase II, open-label, multicenter study of pasireotide in patients with advanced NET whose symptoms of carcinoid syndrome (diarrhea/flushing) were inadequately controlled by octreotide LAR.
Summary · context
Patients received s.c. pasireotide 150 μg twice daily (bid), escalated to a maximum dose of 1200 μg bid until a clinical response was achieved.
Summary · context
Forty-four patients were evaluated for efficacy and 45 for tolerability.
Report a problemFND-2280749708
06HumanNon-randomized trialEfficacy outcome
In advanced NET with carcinoid symptoms inadequately controlled by octreotide LAR, pasireotide controlled diarrhea and flushing in 27% of patients.
In plain wordsIn patients with advanced NET and symptoms resistant to octreotide LAR, pasireotide controlled diarrhea and flushing in 27%.
Peptide
Pasireotide
Outcome
Not applicableDiarrhea and flushing symptom control
Study
n = 44
Outcome group
Gastrointestinal protection · Gastrointestinal
Studied dose
600-900 μg twice daily · subcutaneousAs given in this study (human).
Measurements
Patients with symptom control
27%
diarrhea and flushing; pasireotide 600-900 μg s.c. bid
Source sentences
Summary
Pasireotide 600-900 μg s.c. bid effectively controlled the symptoms of diarrhea and flushing in 27% of patients.
3 context sentences(design, population, supporting numbers)
Summary · context
This was a phase II, open-label, multicenter study of pasireotide in patients with advanced NET whose symptoms of carcinoid syndrome (diarrhea/flushing) were inadequately controlled by octreotide LAR.
Summary · context
Patients received s.c. pasireotide 150 μg twice daily (bid), escalated to a maximum dose of 1200 μg bid until a clinical response was achieved.
Summary · context
Forty-four patients were evaluated for efficacy and 45 for tolerability.
Report a problemFND-2280749701
07HumanNon-randomized trialEfficacy outcome
In advanced NET patients evaluated for tumor response during pasireotide treatment, 13 of 23 had stable disease at study end.
In plain wordsIn patients with advanced NET receiving pasireotide, 13 of 23 evaluated patients had stable disease at study end.
Peptide
Pasireotide
Outcome
Not applicableStable disease
Study
n = 23
Outcome group
Tumor growth · Cancer
Studied dose
150 μg twice daily, escalated to a maximum of 1200 μg twice daily · subcutaneousAs given in this study (human).
Measurements
Patients with stable disease
13 patients
of 23 evaluated for tumor response, at study end
Source sentences
Summary
Evaluation of tumor response in 23 patients showed 13 with stable disease and ten with progressive disease at study end.
3 context sentences(design, population, supporting numbers)
Summary · context
This was a phase II, open-label, multicenter study of pasireotide in patients with advanced NET whose symptoms of carcinoid syndrome (diarrhea/flushing) were inadequately controlled by octreotide LAR.
Summary · context
Patients received s.c. pasireotide 150 μg twice daily (bid), escalated to a maximum dose of 1200 μg bid until a clinical response was achieved.
Summary · context
Forty-four patients were evaluated for efficacy and 45 for tolerability.
Report a problemFND-2280749702
08HumanNon-randomized trialEfficacy outcome
In advanced NET patients evaluated for tumor response during pasireotide treatment, ten of 23 had progressive disease at study end.
In plain wordsIn patients with advanced NET receiving pasireotide, ten of 23 evaluated patients had progressive disease at study end.
Peptide
Pasireotide
Outcome
Not applicableProgressive disease
Study
n = 23
Outcome group
Tumor growth · Cancer
Studied dose
150 μg twice daily, escalated to a maximum of 1200 μg twice daily · subcutaneousAs given in this study (human).
Measurements
Patients with progressive disease
10 patients
of 23 evaluated for tumor response, at study end
Source sentences
Summary
Evaluation of tumor response in 23 patients showed 13 with stable disease and ten with progressive disease at study end.
3 context sentences(design, population, supporting numbers)
Summary · context
This was a phase II, open-label, multicenter study of pasireotide in patients with advanced NET whose symptoms of carcinoid syndrome (diarrhea/flushing) were inadequately controlled by octreotide LAR.
Summary · context
Patients received s.c. pasireotide 150 μg twice daily (bid), escalated to a maximum dose of 1200 μg bid until a clinical response was achieved.
Summary · context
Forty-four patients were evaluated for efficacy and 45 for tolerability.
Report a problemFND-2280749703

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 3Current
28 Oct 2026, 02:03 UTC
Study results updated
Version 2
27 Oct 2026, 16:36 UTC
Study data updated · source update from Europe PMC
Version 1
27 Oct 2026, 16:34 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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