NCT01253161 · STUDY IN CONTEXT

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

Draft scope assessment: unclear. Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

PFS: Defined as the time from the date of first study treatment to the date of the first documented disease progression, by Response Evaluation Criteria in Solid Tumors (RECIST 1.0) guidelines, or death due to any cause. Progressive Disease (PD): at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.

Evaluable participants

→

secondary · POSTED

Complete response (CR): complete disappearance of all target lesions, confirmed by repeat assessments at no less than 4 weeks after the criteria for response are first met. Partial response (PR): at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. This must be confirmed by repeat assessment at no less than 4 weeks after the criteria for response are first met. Stable Disease (SD): neither sufficient decrease to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started.

evaluable participants

→

secondary · POSTED

Adverse Events (AEs) and Serious Adverse Events (SAEs) will be evaluated continuously throughout the study. Safety and tolerability will be assessed according to the NIH/NCI Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0).

All participants who received at least one dose of study drug

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Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

No linked quality-of-life measure is recorded for this setting and study.

Full draft applicability and source-link record

trial

release id: clinical-indications-draft-1
disease state id: ds-neuroendocrine-tumor-bynfezia-pen-866ed972
nct id: NCT01253161
trial label: Study of Pasireotide Long Acting Release (LAR) in Patients With Metastatic Neuroendocrine Tumors (NETs)
applicability: unclear
applicability note: Attached because the study's own record describes metastatic disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
curation status: draft
reviewed by: Source null
reviewed at: Source null
created at: 2026-09-10T00:00:00Z
provenance class: registry-condition-search
discovery note: Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count: 3
harms Count: 1
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-neuroendocrine-tumor-bynfezia-pen-866ed972
nct id
NCT01253161
outcome key
om-0000
source section id
NCT01253161-om-0000
source outcome index
0
endpoint
Progression-free Survival (PFS) at One Year
endpoint definition
PFS: Defined as the time from the date of first study treatment to the date of the first documented disease progression, by Response Evaluation Criteria in Solid Tumors (RECIST 1.0) guidelines, or death due to any cause. Progressive Disease (PD): at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions.
time origin
12 months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
Evaluable participants
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-neuroendocrine-tumor-bynfezia-pen-866ed972
nct id
NCT01253161
outcome key
om-0001
source section id
NCT01253161-om-0001
source outcome index
1
endpoint
Overall Radiographic Response Rate (ORR)
endpoint definition
Complete response (CR): complete disappearance of all target lesions, confirmed by repeat assessments at no less than 4 weeks after the criteria for response are first met. Partial response (PR): at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter. This must be confirmed by repeat assessment at no less than 4 weeks after the criteria for response are first met. Stable Disease (SD): neither sufficient decrease to qualify for partial response nor sufficient increase to qualify for progressive disease, taking as reference the smallest sum longest diameter since the treatment started.
time origin
Up to 48 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
evaluable participants
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
release id
clinical-indications-draft-1
disease state id
ds-neuroendocrine-tumor-bynfezia-pen-866ed972
nct id
NCT01253161
outcome key
om-0002
source section id
NCT01253161-om-0002
source outcome index
2
endpoint
Adverse Events Possibly Related to Study Treatment
endpoint definition
Adverse Events (AEs) and Serious Adverse Events (SAEs) will be evaluated continuously throughout the study. Safety and tolerability will be assessed according to the NIH/NCI Common Terminology Criteria for Adverse Events version 4.0 (CTCAE v4.0).
time origin
Up to 48 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
All participants who received at least one dose of study drug
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

arms

release id
clinical-indications-draft-1
disease state id
ds-neuroendocrine-tumor-bynfezia-pen-866ed972
nct id
NCT01253161
outcome key
om-0000
arm key
OG000
arm label
Pasireotide LAR Treatment
regimen
The investigational drug used in this study is pasireotide long acting release (LAR) 60 mg. Pasireotide Long Acting Release (LAR): Pasireotide will be administered as an intramuscular injection at the beginning of every cycle which is defined as 28 days (+/- 3 days). Study treatment should begin within 14 days following enrollment into the study and continue until disease progression, unacceptable toxicity, or withdrawal of consent.
analyzed count
28
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01253161-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-neuroendocrine-tumor-bynfezia-pen-866ed972
nct id
NCT01253161
outcome key
om-0001
arm key
OG000
arm label
Pasireotide LAR Treatment
regimen
The investigational drug used in this study is pasireotide long acting release (LAR) 60 mg. Pasireotide Long Acting Release (LAR): Pasireotide will be administered as an intramuscular injection at the beginning of every cycle which is defined as 28 days (+/- 3 days). Study treatment should begin within 14 days following enrollment into the study and continue until disease progression, unacceptable toxicity, or withdrawal of consent.
analyzed count
28
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01253161-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-neuroendocrine-tumor-bynfezia-pen-866ed972
nct id
NCT01253161
outcome key
om-0002
arm key
OG000
arm label
Pasireotide LAR Treatment
regimen
The investigational drug used in this study is pasireotide long acting release (LAR) 60 mg. Pasireotide Long Acting Release (LAR): Pasireotide will be administered as an intramuscular injection at the beginning of every cycle which is defined as 28 days (+/- 3 days). Study treatment should begin within 14 days following enrollment into the study and continue until disease progression, unacceptable toxicity, or withdrawal of consent.
analyzed count
29
analyzed unit
Participants
is comparator
Source null
source pointer
NCT01253161-om-0002#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-neuroendocrine-tumor-bynfezia-pen-866ed972
nct id
NCT01253161
harm key
EG000
source section id
NCT01253161-ae
event group key
EG000
event group label
Pasireotide LAR Treatment
serious affected
12
serious at risk
29
other affected
28
other at risk
29
frequency threshold
0
collection period
Adverse events collected for 28 days after last dose of study drug, up to 60 months.
event definition
Source null
undenominated note
Source null
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z

quality of life

setting source links

Preserved source evidence · Not medical advice