Phase II clinical trial of pasireotide long-acting repeatable in patients with metastatic neuroendocrine tumors.

Cives M, Kunz PL, Morse B, Coppola D, Schell MJ, Campos T, Nguyen PT, Nandoskar P, Khandelwal V, Strosberg JR

Endocrine-related cancer6 Nov 2014Cited by 74 (Europe PMC)

PMID25376618PMCIDPMC4643672DOI10.1530/erc-14-0360PepBankPUB-25376618

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 study9

9 results from studies that gave the peptide. 9 results from people.

01HumanNon-randomized trialEfficacy outcome
In patients with metastatic NETs, median progression-free survival with pasireotide was 11 months.
In plain wordsIn patients with metastatic NETs, median time without progression with pasireotide was 11 months.
Peptide
Pasireotide
Outcome
Not applicableProgression-free survival
Study
n = 29
Analysis
Primary
Outcome group
Tumor growth · Cancer
Studied dose
60 mg every 4 weeksAs given in this study (human).
Measurements
Median progression-free survival
11 months
pasireotide LAR 60 mg every 4 weeks
Source sentences
Summary
The median PFS was 11 months.
2 context sentences(design, population, supporting numbers)
Summary · context
This open-label, phase II study assessed the clinical activity of pasireotide in treatment-naïve patients with metastatic grade 1 or 2 NETs.
Summary · context
Patients with metastatic pancreatic and extra-pancreatic NETs were treated with pasireotide LAR (60 mg every 4 weeks).
Report a problemFND-2537661801
02HumanNon-randomized trialEfficacy outcome
In patients with metastatic NETs receiving pasireotide, median overall survival was not reached and 30-month survival was 70%.
In plain wordsIn patients with metastatic NETs receiving pasireotide, survival at 30 months was 70%, and median survival was not reached.
Peptide
Pasireotide
Outcome
Not applicableOverall survival
Study
n = 29
Analysis
Secondary
Outcome group
Mortality · Cancer
Studied dose
60 mg every 4 weeksAs given in this study (human).
Measurements
30-month overall survival rate
70%
pasireotide LAR
Source sentences
Summary
Median OS has not been reached; the 30-month OS rate was 70%.
2 context sentences(design, population, supporting numbers)
Summary · context
This open-label, phase II study assessed the clinical activity of pasireotide in treatment-naïve patients with metastatic grade 1 or 2 NETs.
Summary · context
Patients with metastatic pancreatic and extra-pancreatic NETs were treated with pasireotide LAR (60 mg every 4 weeks).
Report a problemFND-2537661803
03HumanNon-randomized trialSafety outcome
In patients with metastatic NETs, pasireotide LAR was associated with hyperglycemia in 79%.
In plain wordsIn patients with metastatic NETs, 79% had high blood sugar during pasireotide LAR treatment.
Peptide
Pasireotide
Outcome
Not applicableHyperglycemia
Study
n = 29
Analysis
Secondary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
60 mg every 4 weeksAs given in this study (human).
Measurements
Hyperglycemia rate
79%
pasireotide LAR
Source sentences
Summary
Although grade 3/4 toxicities were rare, pasireotide LAR treatment was associated with a 79% rate of hyperglycemia including 14% grade 3 hyperglycemia.
2 context sentences(design, population, supporting numbers)
Summary · context
This open-label, phase II study assessed the clinical activity of pasireotide in treatment-naïve patients with metastatic grade 1 or 2 NETs.
Summary · context
Patients with metastatic pancreatic and extra-pancreatic NETs were treated with pasireotide LAR (60 mg every 4 weeks).
Report a problemFND-2537661807
04HumanNon-randomized trialSafety outcome
In patients with metastatic NETs receiving pasireotide, grade 3/4 toxicities were rare.
In plain wordsIn patients with metastatic NETs receiving pasireotide, grade 3/4 toxicities were rare.
Peptide
Pasireotide
Outcome
Not applicableGrade 3/4 toxicities
Study
n = 29
Analysis
Secondary
Outcome group
Adverse events · Whole body
Studied dose
60 mg every 4 weeksAs given in this study (human).
Source sentences
Summary
Although grade 3/4 toxicities were rare, pasireotide LAR treatment was associated with a 79% rate of hyperglycemia including 14% grade 3 hyperglycemia.
2 context sentences(design, population, supporting numbers)
Summary · context
This open-label, phase II study assessed the clinical activity of pasireotide in treatment-naïve patients with metastatic grade 1 or 2 NETs.
Summary · context
Patients with metastatic pancreatic and extra-pancreatic NETs were treated with pasireotide LAR (60 mg every 4 weeks).
Report a problemFND-2537661808
05HumanNon-randomized trialSafety outcome
In patients with metastatic NETs, grade 3 hyperglycemia occurred in 14% during pasireotide LAR treatment.
In plain wordsIn patients with metastatic NETs, 14% had grade 3 high blood sugar during pasireotide LAR treatment.
Peptide
Pasireotide
Outcome
Not applicableGrade 3 hyperglycemia
Study
n = 29
Analysis
Secondary
Outcome group
Glycemic control · Metabolic and weight
Studied dose
60 mg every 4 weeksAs given in this study (human).
Measurements
Grade 3 hyperglycemia rate
14%
pasireotide LAR
Source sentences
Summary
Although grade 3/4 toxicities were rare, pasireotide LAR treatment was associated with a 79% rate of hyperglycemia including 14% grade 3 hyperglycemia.
3 context sentences(design, population, supporting numbers)
Summary · context
This open-label, phase II study assessed the clinical activity of pasireotide in treatment-naïve patients with metastatic grade 1 or 2 NETs.
Summary · context
Patients with metastatic pancreatic and extra-pancreatic NETs were treated with pasireotide LAR (60 mg every 4 weeks).
Summary · context
Twenty-nine patients were treated with pasireotide LAR (60 mg every 4 weeks) and 28 were evaluable for response.
Report a problemFND-2537661809
06HumanNon-randomized trialEfficacy outcome
In patients with metastatic NETs given pasireotide LAR, the best radiographic response was partial response in one patient (4%).
In plain wordsIn patients with metastatic NETs given pasireotide LAR, the best scan response was partial response in one patient (4%).
Peptide
Pasireotide
Outcome
Not applicablePartial response
Study
n = 28
Analysis
Secondary
Outcome group
Tumor growth · Cancer
Studied dose
60 mg every 4 weeksAs given in this study (human).
Measurements
Patients with best response of partial response
1 patients
pasireotide LAR
Patients with best response of partial response
4%
pasireotide LAR
Source sentences
Summary
The best radiographic response was partial response in one patient (4%), stable disease in 17 patients (60%), and progressive disease in ten patients (36%).
2 context sentences(design, population, supporting numbers)
Summary · context
This open-label, phase II study assessed the clinical activity of pasireotide in treatment-naïve patients with metastatic grade 1 or 2 NETs.
Summary · context
Patients with metastatic pancreatic and extra-pancreatic NETs were treated with pasireotide LAR (60 mg every 4 weeks).
Report a problemFND-2537661804
07HumanNon-randomized trialEfficacy outcome
In patients with metastatic NETs given pasireotide LAR, the best radiographic response was stable disease in 17 patients (60%).
In plain wordsIn patients with metastatic NETs given pasireotide LAR, the best scan response was stable disease in 17 patients (60%).
Peptide
Pasireotide
Outcome
Not applicableStable disease
Study
n = 28
Analysis
Secondary
Outcome group
Tumor growth · Cancer
Studied dose
60 mg every 4 weeksAs given in this study (human).
Measurements
Patients with best response of stable disease
17 patients
pasireotide LAR
Patients with best response of stable disease
60%
pasireotide LAR
Source sentences
Summary
The best radiographic response was partial response in one patient (4%), stable disease in 17 patients (60%), and progressive disease in ten patients (36%).
2 context sentences(design, population, supporting numbers)
Summary · context
This open-label, phase II study assessed the clinical activity of pasireotide in treatment-naïve patients with metastatic grade 1 or 2 NETs.
Summary · context
Patients with metastatic pancreatic and extra-pancreatic NETs were treated with pasireotide LAR (60 mg every 4 weeks).
Report a problemFND-2537661805
08HumanNon-randomized trialEfficacy outcome
In patients with metastatic NETs given pasireotide LAR, the best radiographic response was progressive disease in ten patients (36%).
In plain wordsIn patients with metastatic NETs given pasireotide LAR, the best scan response was progressive disease in ten patients (36%).
Peptide
Pasireotide
Outcome
Not applicableProgressive disease
Study
n = 28
Analysis
Secondary
Outcome group
Tumor growth · Cancer
Studied dose
60 mg every 4 weeksAs given in this study (human).
Measurements
Patients with best response of progressive disease
10 patients
pasireotide LAR
Patients with best response of progressive disease
36%
pasireotide LAR
Source sentences
Summary
The best radiographic response was partial response in one patient (4%), stable disease in 17 patients (60%), and progressive disease in ten patients (36%).
2 context sentences(design, population, supporting numbers)
Summary · context
This open-label, phase II study assessed the clinical activity of pasireotide in treatment-naïve patients with metastatic grade 1 or 2 NETs.
Summary · context
Patients with metastatic pancreatic and extra-pancreatic NETs were treated with pasireotide LAR (60 mg every 4 weeks).
Report a problemFND-2537661806
09HumanObservational studyEfficacy outcome
In patients with metastatic NETs, pasireotide effects were most favorable with low hepatic tumor burden, normal chromogranin A, and high SSTR5 expression.
In plain wordsIn patients with metastatic NETs, pasireotide effects were most favorable with low liver tumor burden, normal chromogranin A, and high SSTR5 expression.
Peptide
Pasireotide
Outcome
Not applicableResponse-associated characteristics
Study
n: not reported in source
Outcome group
Tumor growth · Cancer
Studied dose
60 mg every 4 weeksAs given in this study (human).
Source sentences
Summary
The most favorable effect was observed in patients with low hepatic tumor burden, normal baseline chromogranin A, and high tumoral SSTR5 expression.
2 context sentences(design, population, supporting numbers)
Summary · context
This open-label, phase II study assessed the clinical activity of pasireotide in treatment-naïve patients with metastatic grade 1 or 2 NETs.
Summary · context
Patients with metastatic pancreatic and extra-pancreatic NETs were treated with pasireotide LAR (60 mg every 4 weeks).
Report a problemFND-2537661802

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

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 2Results postedNCT01253161

Study of Pasireotide Long Acting Release (LAR) in Patients With Metastatic Neuroendocrine Tumors (NETs)

H. Lee Moffitt Cancer Center and Research Instituten = 291 Feb 2011 to 2 Mar 2023

Neuroendocrine Tumors · Carcinoid Tumors

Trial page ClinicalTrials.govUpdated 6 Mar 2023

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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