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← Neuroendocrine Tumor

NCT01283542 · STUDY IN CONTEXT

Evaluate the Efficacy and Safety of Pasireotide LAR (Long Acting Release) on the Treatment of Patients With Clinically Non-Functioning Pituitary Adenoma.

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

Tumor volume was evaluated by MRI. MRIs were performed and processed according to the guidelines of the central evaluator's facility.The pituitary adenomas were measured by a neuro-radiologist, using manual tracing together with the imaging analysis software. The largest diameter at any plan determined the maximum diameter of the tumor. A change ≥ 20% in the original volume of the tumor was considered to be clinically significant. Evaluable participants required tumor volume assessment at baseline and at week 24.

Evaluable participants required tumor volume assessment at baseline and at week 24

→

secondary · POSTED

Tumor volume was evaluated by MRI. MRIs were performed and processed according to the guidelines of the central evaluator's facility. The pituitary adenomas were measured by a neuro-radiologist, using manual tracing together with the imaging analysis software. The largest diameter at any plan determined the maximum diameter of the tumor.

number of participants with evaluable data varied across visits

→

secondary · POSTED

Tumor volume was evaluated by MRI. MRIs were performed and processed according to the guidelines of the central evaluator's facility. The pituitary adenomas were measured by a neuro-radiologist, using manual tracing together with the imaging analysis software. The largest diameter at any plan determined the maximum diameter of the tumor.

number of participants with evaluable data varied across visits

→

secondary · POSTED

Tumor volume was evaluated by MRI. MRIs were performed and processed according to the guidelines of the central evaluator's facility. The pituitary adenomas were measured by a neuro-radiologist, using manual tracing together with the imaging analysis software. The largest diameter at any plan determined the maximum diameter of the tumor.

number of participants with evaluable data varied across visits

→

secondary · POSTED

Tumor volume was evaluated by MRI. MRIs were performed and processed according to the guidelines of the central evaluator's facility. The pituitary adenomas were measured by a neuro-radiologist, using manual tracing together with the imaging analysis software. The largest diameter at any plan determined the maximum diameter of the tumor.

number of participants with evaluable data varied across visits

→

secondary · POSTED

Tumor volume was evaluated by MRI. MRIs were performed and processed according to the guidelines of the central evaluator's facility. The pituitary adenomas were measured by a neuro-radiologist, using manual tracing together with the imaging analysis software. The largest diameter at any plan determined the maximum diameter of the tumor.

number of participants with evaluable data varied across visits

→

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

FACT · Mean ACTH and Estradiol Hormone Levels During Main and Extension Phases (FAS)

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-neuroendocrine-tumor
nct id
NCT01283542
qol key
qol-0013
source section id
NCT01283542-om-0013
source outcome index
13
instrument
FACT
instrument basis
matched 'factor' in the study's own wording
scale title
Mean ACTH and Estradiol Hormone Levels During Main and Extension Phases (FAS)
measure definition
Hormone levels, including those of growth hormone (GH),insulin-like growth factor 1 (IGF-1), follicle-stimulating hormone (FSH), luteinizing hormone (LH), adrenocorticotropic hormone (ACTH), thyroid-stimulating hormone (TSH), prolactin, cortisol, free thyroxine (free T4), and estradiol (for women) or testosterone (for men), were evaluated by a central lab
time frame
Baseline and at weeks 24, 48, 96
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
participants with evaluable data varied across visits
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-neuroendocrine-tumor
nct id
NCT01283542
trial label
Evaluate the Efficacy and Safety of Pasireotide LAR (Long Acting Release) on the Treatment of Patients With Clinically Non-Functioning Pituitary Adenoma.
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
1
qol Count
1
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroendocrine-tumor
    nct id
    NCT01283542
    outcome key
    om-0000
    source section id
    NCT01283542-om-0000
    source outcome index
    0
    endpoint
    Percentage of Participants With Non-functioning Pituitary Adenomas (NFPA) Who Achieve Tumor Volume Reduction of at Least 20% After 24 Weeks (FAS)
    endpoint definition
    Tumor volume was evaluated by MRI. MRIs were performed and processed according to the guidelines of the central evaluator's facility.The pituitary adenomas were measured by a neuro-radiologist, using manual tracing together with the imaging analysis software. The largest diameter at any plan determined the maximum diameter of the tumor. A change ≥ 20% in the original volume of the tumor was considered to be clinically significant. Evaluable participants required tumor volume assessment at baseline and at week 24.
    time origin
    Baseline up to 24 weeks
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Evaluable participants required tumor volume assessment at baseline and at week 24
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroendocrine-tumor
    nct id
    NCT01283542
    outcome key
    om-0001
    source section id
    NCT01283542-om-0001
    source outcome index
    1
    endpoint
    Tumor Volume Main Phase (FAS)
    endpoint definition
    Tumor volume was evaluated by MRI. MRIs were performed and processed according to the guidelines of the central evaluator's facility. The pituitary adenomas were measured by a neuro-radiologist, using manual tracing together with the imaging analysis software. The largest diameter at any plan determined the maximum diameter of the tumor.
    time origin
    baseline to week 4, 12, 24
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    number of participants with evaluable data varied across visits
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroendocrine-tumor
    nct id
    NCT01283542
    outcome key
    om-0002
    source section id
    NCT01283542-om-0002
    source outcome index
    2
    endpoint
    Tumor Volume in Extension Phase (FAS)
    endpoint definition
    Tumor volume was evaluated by MRI. MRIs were performed and processed according to the guidelines of the central evaluator's facility. The pituitary adenomas were measured by a neuro-radiologist, using manual tracing together with the imaging analysis software. The largest diameter at any plan determined the maximum diameter of the tumor.
    time origin
    baseline to week 48, 72, 96
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    number of participants with evaluable data varied across visits
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroendocrine-tumor
    nct id
    NCT01283542
    outcome key
    om-0003
    source section id
    NCT01283542-om-0003
    source outcome index
    3
    endpoint
    Tumor Volume Change From Baseline in Main Phase (FAS)
    endpoint definition
    Tumor volume was evaluated by MRI. MRIs were performed and processed according to the guidelines of the central evaluator's facility. The pituitary adenomas were measured by a neuro-radiologist, using manual tracing together with the imaging analysis software. The largest diameter at any plan determined the maximum diameter of the tumor.
    time origin
    baseline to week 4, 12, 24
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    number of participants with evaluable data varied across visits
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroendocrine-tumor
    nct id
    NCT01283542
    outcome key
    om-0004
    source section id
    NCT01283542-om-0004
    source outcome index
    4
    endpoint
    Tumor Volume Change From Baseline in Extension Phase (FAS)
    endpoint definition
    Tumor volume was evaluated by MRI. MRIs were performed and processed according to the guidelines of the central evaluator's facility. The pituitary adenomas were measured by a neuro-radiologist, using manual tracing together with the imaging analysis software. The largest diameter at any plan determined the maximum diameter of the tumor.
    time origin
    baseline to week 48, 72, 96
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    number of participants with evaluable data varied across visits
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroendocrine-tumor
    nct id
    NCT01283542
    outcome key
    om-0005
    source section id
    NCT01283542-om-0005
    source outcome index
    5
    endpoint
    Tumor Volume Percent Change From Baseline in Main Phase (FAS)
    endpoint definition
    Tumor volume was evaluated by MRI. MRIs were performed and processed according to the guidelines of the central evaluator's facility. The pituitary adenomas were measured by a neuro-radiologist, using manual tracing together with the imaging analysis software. The largest diameter at any plan determined the maximum diameter of the tumor.
    time origin
    baseline to week 4, 12, 24
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    number of participants with evaluable data varied across visits
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroendocrine-tumor
    nct id
    NCT01283542
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Pasireotide LAR
    regimen
    All patients will receive pasireotide LAR (long acting release) 60 mg every 28 ± 3 days for 24 weeks
    analyzed count
    12
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01283542-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroendocrine-tumor
    nct id
    NCT01283542
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Pasireotide LAR
    regimen
    All patients will receive pasireotide LAR (long acting release) 60 mg every 28 ± 3 days for 24 weeks
    analyzed count
    20
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01283542-om-0001#groups/OG000
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroendocrine-tumor
    nct id
    NCT01283542
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Pasireotide LAR
    regimen
    All patients will receive pasireotide LAR (long acting release) 60 mg every 28 ± 3 days for 24 weeks
    analyzed count
    13
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01283542-om-0002#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroendocrine-tumor
    nct id
    NCT01283542
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Pasireotide LAR
    regimen
    All patients will receive pasireotide LAR (long acting release) 60 mg every 28 ± 3 days for 24 weeks
    analyzed count
    20
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01283542-om-0003#groups/OG000
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroendocrine-tumor
    nct id
    NCT01283542
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Pasireotide LAR
    regimen
    All patients will receive pasireotide LAR (long acting release) 60 mg every 28 ± 3 days for 24 weeks
    analyzed count
    13
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01283542-om-0004#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroendocrine-tumor
    nct id
    NCT01283542
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Pasireotide LAR
    regimen
    All patients will receive pasireotide LAR (long acting release) 60 mg every 28 ± 3 days for 24 weeks
    analyzed count
    20
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT01283542-om-0005#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroendocrine-tumor
    nct id
    NCT01283542
    harm key
    EG000
    source section id
    NCT01283542-ae
    event group key
    EG000
    event group label
    Pasireotide LAR
    serious affected
    2
    serious at risk
    20
    other affected
    17
    other at risk
    20
    frequency threshold
    5
    collection period
    Adverse Events (AEs) are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All AEs reported in this record are from date of First Patient First Treatment until Last Patient Last Visit) up to approximately 104 weeks
    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
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroendocrine-tumor
    nct id
    NCT01283542
    qol key
    qol-0013
    source section id
    NCT01283542-om-0013
    source outcome index
    13
    instrument
    FACT
    instrument basis
    matched 'factor' in the study's own wording
    scale title
    Mean ACTH and Estradiol Hormone Levels During Main and Extension Phases (FAS)
    measure definition
    Hormone levels, including those of growth hormone (GH),insulin-like growth factor 1 (IGF-1), follicle-stimulating hormone (FSH), luteinizing hormone (LH), adrenocorticotropic hormone (ACTH), thyroid-stimulating hormone (TSH), prolactin, cortisol, free thyroxine (free T4), and estradiol (for women) or testosterone (for men), were evaluated by a central lab
    time frame
    Baseline and at weeks 24, 48, 96
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    participants with evaluable data varied across visits
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
setting source links

    Preserved source evidence · Not medical advice