NCT00958841 · STUDY IN CONTEXT

Study of Pasireotide in Patients With Rare Tumors of Neuroendocrine Origin

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm. 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

The primary efficacy endpoint was defined as the percentage of responders at Month 6 among pooled PNET patients (insulinoma, gastrinoma, VIPoma, and glucagonoma). A responder was defined as a patient who either attained normalization or had a greater than 50% reduction from baseline of the level of the primary biochemical tumor marker at Month 6 (M6). Four insulinoma pts were excluded from analysis because of unavailability of normal ranges for the associated primary biochemical tumor marker (insulin-to-glucose ratio). One patient with VIPoma with a normal baseline was also excluded. As a result, only 20 out of 25 patients with PNET were included in the assessment of the primary endpoint, which was less than the planned sample size of 34. Therefore, the primary objective could not be assessed with sufficient power. Patients with missing Month 6 assessment were considered as non-responders. Responder analyses are reported only for indications with minimum of 6 patients.

The efficacy analyzable set included all enrolled patients who received at least one dose of pasireotide LAR and had indication-specific baseline primary biochemical tumor marker levels \>ULN. Patients with baseline primary biochemical tumor marker levels either missing at baseline or missing ULN or baseline value ≤ ULN were excluded.

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secondary · POSTED

Percentage of responders for each of the 10 NET indications considered in the study. Responder analyses were performed for an indication only if there were at least 6 patients in the efficacy analyzable set. For all other individual indications, the numbers of patients in the efficacy analyzable sets were less than 6 and therefore no responder analyses were carried out for these indications.

The efficacy analyzable set included all enrolled patients who received at least one dose of pasireotide LAR and had indication-specific baseline primary biochemical tumor marker levels \>ULN.

→

secondary · POSTED

Percentage of responders for each of the 10 NET indications considered in the study. Responder analyses were performed for an indication only if there were at least 6 patients in the efficacy analyzable set. For all other individual indications, the numbers of patients in the efficacy analyzable sets were less than 6 and therefore no responder analyses were carried out for these indications. The probability of success was a chance that the true responder rate was greater than 15%) for the indications gastrinoma, prolactinoma, and Nelson's syndrome.

The efficacy analyzable set included all enrolled patients who received at least one dose of pasireotide LAR and had indication-specific baseline primary biochemical tumor marker levels \>ULN.

→

secondary · POSTED

Specific primary biochemical tumor markers were used to assess the efficacy of pasireotide in PNETs. A Month 6 responder was defined as the patients who either attained normalization or greater than 50% reduction from baseline in the level of the primary biochemical tumor marker at Month 6. One gastrinoma patient had a missing primary tumor marker value at Month 6, but had a Month 5 assessment done on Day 141, which fell within the allowed window period for Month 6.

The efficacy analyzable set included all enrolled patients who received at least one dose of pasireotide LAR and had indication-specific baseline primary biochemical tumor marker levels \>ULN. Responder analysis are reported only for indications with minimum of 6 patients. Patients with missing Month 6 assessment were considered as non-responders.

→

secondary · POSTED

Specific primary biochemical tumor markers were used to assess the efficacy of pasireotide in PNETs. A Month 6 responder was defined as the patients who either attained normalization or greater than 50% reduction from baseline in the level of the primary biochemical tumor marker at Month 6.

The efficacy analyzable set included all enrolled patients who received at least one dose of pasireotide LAR and had indication-specific baseline primary biochemical tumor marker levels \>ULN. Responder analysis are reported only for indications with minimum of 6 patients. Patients with missing Month 6 assessment were considered as non-responders.

→

secondary · POSTED

Six patients with Nelson's syndrome met the responder's criteria of attaining normalization or a reduction of more than 50% in primary tumor marker at Month 6.

The efficacy analyzable set included all enrolled patients who received at least one dose of pasireotide LAR and had indication-specific baseline primary biochemical tumor marker levels \>ULN. Responder analysis are reported only for indications with minimum of 6 patients. Patients with missing Month 6 assessment were considered as non-responders.

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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-pancreatic-cancer
nct id: NCT00958841
trial label: Study of Pasireotide in Patients With Rare Tumors of Neuroendocrine Origin
applicability: narrower
applicability note: Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. The condition was transformed or resolved through the terminology hierarchy to reach this cancer type, so the link itself is a candidate a reviewer must confirm.
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: 6
harms Count: 4
qol Count: 0

outcomes

release id
clinical-indications-draft-1
disease state id
ds-pancreatic-cancer
nct id
NCT00958841
outcome key
om-0000
source section id
NCT00958841-om-0000
source outcome index
0
endpoint
Percentage of Responders at Month 6 - Pooled Pancreatic NETs (PNETs)
endpoint definition
The primary efficacy endpoint was defined as the percentage of responders at Month 6 among pooled PNET patients (insulinoma, gastrinoma, VIPoma, and glucagonoma). A responder was defined as a patient who either attained normalization or had a greater than 50% reduction from baseline of the level of the primary biochemical tumor marker at Month 6 (M6). Four insulinoma pts were excluded from analysis because of unavailability of normal ranges for the associated primary biochemical tumor marker (insulin-to-glucose ratio). One patient with VIPoma with a normal baseline was also excluded. As a result, only 20 out of 25 patients with PNET were included in the assessment of the primary endpoint, which was less than the planned sample size of 34. Therefore, the primary objective could not be assessed with sufficient power. Patients with missing Month 6 assessment were considered as non-responders. Responder analyses are reported only for indications with minimum of 6 patients.
time origin
6 months
analysis role
primary
reporting status
POSTED
data cutoff
Source null
population note
The efficacy analyzable set included all enrolled patients who received at least one dose of pasireotide LAR and had indication-specific baseline primary biochemical tumor marker levels \>ULN. Patients with baseline primary biochemical tumor marker levels either missing at baseline or missing ULN or baseline value ≤ ULN were excluded.
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-pancreatic-cancer
nct id
NCT00958841
outcome key
om-0001
source section id
NCT00958841-om-0001
source outcome index
1
endpoint
Percentage of Responders at Month 6 - Individual NETs
endpoint definition
Percentage of responders for each of the 10 NET indications considered in the study. Responder analyses were performed for an indication only if there were at least 6 patients in the efficacy analyzable set. For all other individual indications, the numbers of patients in the efficacy analyzable sets were less than 6 and therefore no responder analyses were carried out for these indications.
time origin
6 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
The efficacy analyzable set included all enrolled patients who received at least one dose of pasireotide LAR and had indication-specific baseline primary biochemical tumor marker levels \>ULN.
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-pancreatic-cancer
nct id
NCT00958841
outcome key
om-0002
source section id
NCT00958841-om-0002
source outcome index
2
endpoint
Percentage of Responders With Probability of Success at Month 6 - Individual NETs
endpoint definition
Percentage of responders for each of the 10 NET indications considered in the study. Responder analyses were performed for an indication only if there were at least 6 patients in the efficacy analyzable set. For all other individual indications, the numbers of patients in the efficacy analyzable sets were less than 6 and therefore no responder analyses were carried out for these indications. The probability of success was a chance that the true responder rate was greater than 15%) for the indications gastrinoma, prolactinoma, and Nelson's syndrome.
time origin
6 months
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
The efficacy analyzable set included all enrolled patients who received at least one dose of pasireotide LAR and had indication-specific baseline primary biochemical tumor marker levels \>ULN.
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-pancreatic-cancer
nct id
NCT00958841
outcome key
om-0003
source section id
NCT00958841-om-0003
source outcome index
3
endpoint
PNETs: Number of Patients Attaining Normalization or a More Than 50% Reduction in Primary Biochemical Tumor Marker
endpoint definition
Specific primary biochemical tumor markers were used to assess the efficacy of pasireotide in PNETs. A Month 6 responder was defined as the patients who either attained normalization or greater than 50% reduction from baseline in the level of the primary biochemical tumor marker at Month 6. One gastrinoma patient had a missing primary tumor marker value at Month 6, but had a Month 5 assessment done on Day 141, which fell within the allowed window period for Month 6.
time origin
Baseline, month 6
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
The efficacy analyzable set included all enrolled patients who received at least one dose of pasireotide LAR and had indication-specific baseline primary biochemical tumor marker levels \>ULN. Responder analysis are reported only for indications with minimum of 6 patients. Patients with missing Month 6 assessment were considered as non-responders.
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-pancreatic-cancer
nct id
NCT00958841
outcome key
om-0004
source section id
NCT00958841-om-0004
source outcome index
4
endpoint
PiNETs: Number of Patients Attaining Normalization or a More Than 50% Reduction in Primary Biochemical Tumor Marker
endpoint definition
Specific primary biochemical tumor markers were used to assess the efficacy of pasireotide in PNETs. A Month 6 responder was defined as the patients who either attained normalization or greater than 50% reduction from baseline in the level of the primary biochemical tumor marker at Month 6.
time origin
Baseline, month 6
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
The efficacy analyzable set included all enrolled patients who received at least one dose of pasireotide LAR and had indication-specific baseline primary biochemical tumor marker levels \>ULN. Responder analysis are reported only for indications with minimum of 6 patients. Patients with missing Month 6 assessment were considered as non-responders.
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-pancreatic-cancer
nct id
NCT00958841
outcome key
om-0005
source section id
NCT00958841-om-0005
source outcome index
5
endpoint
Nelson's Syndrome: Number of Patients Attaining Normalization or a More Than 50% Reduction in Primary Biochemical Tumor Marker
endpoint definition
Six patients with Nelson's syndrome met the responder's criteria of attaining normalization or a reduction of more than 50% in primary tumor marker at Month 6.
time origin
Baseline, month 6
analysis role
secondary
reporting status
POSTED
data cutoff
Source null
population note
The efficacy analyzable set included all enrolled patients who received at least one dose of pasireotide LAR and had indication-specific baseline primary biochemical tumor marker levels \>ULN. Responder analysis are reported only for indications with minimum of 6 patients. Patients with missing Month 6 assessment were considered as non-responders.
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-pancreatic-cancer
nct id
NCT00958841
outcome key
om-0000
arm key
OG000
arm label
Gastrinoma
regimen
One of the 10 types of PNETs analyzed
analyzed count
13
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00958841-om-0000#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-cancer
nct id
NCT00958841
outcome key
om-0000
arm key
OG001
arm label
VIpoma
regimen
One of the 10 types of PNETs analyzed.
analyzed count
2
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00958841-om-0000#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-cancer
nct id
NCT00958841
outcome key
om-0000
arm key
OG002
arm label
Glucagonoma
regimen
One of the 10 types of PNETs analyzed.
analyzed count
5
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00958841-om-0000#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-cancer
nct id
NCT00958841
outcome key
om-0001
arm key
OG000
arm label
Gastrinoma
regimen
One of the 10 types of PNETs analyzed
analyzed count
13
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00958841-om-0001#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-cancer
nct id
NCT00958841
outcome key
om-0001
arm key
OG001
arm label
Prolactinoma
regimen
One of the 10 types of PNETs analyzed.
analyzed count
37
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00958841-om-0001#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-cancer
nct id
NCT00958841
outcome key
om-0001
arm key
OG002
arm label
Nelson's Syndrome
regimen
based on disease specific primary biochemical tumor markers. Patients received pasireotide LAR at 60 mg approximately once every 28 days for 6 months during the core treatment period and additional treatment cycles up to a total of 48 months during the extension phase.
analyzed count
14
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00958841-om-0001#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-cancer
nct id
NCT00958841
outcome key
om-0002
arm key
OG000
arm label
Gastrinoma
regimen
One of the 10 types of PNETs analyzed
analyzed count
13
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00958841-om-0002#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-cancer
nct id
NCT00958841
outcome key
om-0002
arm key
OG001
arm label
Prolactinoma
regimen
One of the 10 types of PNETs analyzed.
analyzed count
37
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00958841-om-0002#groups/OG001
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-cancer
nct id
NCT00958841
outcome key
om-0002
arm key
OG002
arm label
Nelson's Syndrome
regimen
based on disease specific primary biochemical tumor markers. Patients received pasireotide LAR at 60 mg approximately once every 28 days for 6 months during the core treatment period and additional treatment cycles up to a total of 48 months during the extension phase.
analyzed count
14
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00958841-om-0002#groups/OG002
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-cancer
nct id
NCT00958841
outcome key
om-0003
arm key
OG000
arm label
All PNETS (Gastrinoma)
regimen
One of the 10 types of PNETs analyzed
analyzed count
20
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00958841-om-0003#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-cancer
nct id
NCT00958841
outcome key
om-0004
arm key
OG000
arm label
All PiNETS (Prolactinoma)
regimen
One of the 10 types of PiNETs analyzed
analyzed count
39
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00958841-om-0004#groups/OG000
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-cancer
nct id
NCT00958841
outcome key
om-0005
arm key
OG000
arm label
Nelson's Syndrome
regimen
Nelson's syndrome is associated with local tumor extension or invasion following a therapeutic bilateral adrenalectomy
analyzed count
14
analyzed unit
Participants
is comparator
Source null
source pointer
NCT00958841-om-0005#groups/OG000

harms

release id
clinical-indications-draft-1
disease state id
ds-pancreatic-cancer
nct id
NCT00958841
harm key
EG000
source section id
NCT00958841-ae
event group key
EG000
event group label
Pancreatic NETs (PNETs)
serious affected
10
serious at risk
25
other affected
23
other at risk
25
frequency threshold
5
collection period
Source null
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
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-cancer
nct id
NCT00958841
harm key
EG001
source section id
NCT00958841-ae
event group key
EG001
event group label
Pituitary NETs (PiNETs)
serious affected
8
serious at risk
72
other affected
71
other at risk
72
frequency threshold
5
collection period
Source null
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
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-cancer
nct id
NCT00958841
harm key
EG002
source section id
NCT00958841-ae
event group key
EG002
event group label
Ectopic ACTH-secrting Tumors (EAS)
serious affected
5
serious at risk
7
other affected
7
other at risk
7
frequency threshold
5
collection period
Source null
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
release id
clinical-indications-draft-1
disease state id
ds-pancreatic-cancer
nct id
NCT00958841
harm key
EG003
source section id
NCT00958841-ae
event group key
EG003
event group label
Nelsons Syndrome
serious affected
9
serious at risk
14
other affected
14
other at risk
14
frequency threshold
5
collection period
Source null
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