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← Neuroendocrine Tumor

NCT00412061 · STUDY IN CONTEXT

Everolimus and Octreotide in Patients With Advanced Carcinoid Tumor

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. Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.

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

Progression free survival (PFS) is defined as the time from randomization to the date of first documented disease progression or death from any cause. The primary analysis of PFS was based on the independent central adjudicated assessment using Kaplan-Meier method.

The Full Analysis Set (FAS) consisted of all randomized patients.

→

secondary · POSTED

The best overall response rate is defined as the percentage of patients having achieved confirmed Complete Response + Partial Response. Complete Response (CR) = at least two determinations of CR at least 4 weeks apart before progression. • Partial response (PR) = at least two determinations of PR or better at least 4 weeks apart before progression.

The Full Analysis Set (FAS; Intent-to-treat Population) consists of all randomized patients.

→

secondary · POSTED

5-HIAA levels in urine are frequently elevated in patients with advanced carcinoid tumors. Baseline levels of 5-HIAA in urine were defined as 'High' if they exceeded the median value, and 'Low' if they were lower than or equal to the median.

The Full Analysis Set (FAS; Intent-to-treat Population) consists of all randomized patients. This analysis includes PFS patients with non missing baseline 5-HIAA data.

→

secondary · POSTED

Overall survival was defined as the time from the date of randomization to the date of death from any cause. If a patient was not known to have died, survival was censored at the date of last contact. Kaplan-Meier methodology was used to estimate the median overall survival for each treatment group.

The Full Analysis Set (FAS; Intent-to-treat Population) consists of all randomized patients.

→

secondary · POSTED

AEs are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. SAEs are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.

The Safety Set consists of all patients who received at least one dose of study drug and who had at least one valid post-baseline safety assessment.

→

secondary · POSTED

AEs are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. SAEs are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.

The Safety Set consists of all patients who received at least one dose of study drug and who had at least one valid post-baseline safety assessment.

→

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
nct id
NCT00412061
trial label
Everolimus and Octreotide in Patients With Advanced Carcinoid Tumor
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.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
regulator-cited
discovery note
Found because this study's registry identifier is printed in an FDA approval notice, an FDA product label or an NCI summary held by this site. The citing document and the exact position of the identifier inside it are recorded. Being cited is not a statement that the study supports this treatment.
outcome Count
6
harms Count
3
qol Count
0
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroendocrine-tumor
    nct id
    NCT00412061
    outcome key
    om-0000
    source section id
    NCT00412061-om-0000
    source outcome index
    0
    endpoint
    Progression Free Survival (PFS) as Per Adjudicated Central Radiology Review
    endpoint definition
    Progression free survival (PFS) is defined as the time from randomization to the date of first documented disease progression or death from any cause. The primary analysis of PFS was based on the independent central adjudicated assessment using Kaplan-Meier method.
    time origin
    Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 10 January 2007, until cut-off date 02 April 2010
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The Full Analysis Set (FAS) consisted of all randomized patients.
    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
    NCT00412061
    outcome key
    om-0001
    source section id
    NCT00412061-om-0001
    source outcome index
    1
    endpoint
    Best Overall Response Rate as Per Adjudicated Central Radiology Review Based on Response Evaluation Criteria in Solid Tumors (RECIST)
    endpoint definition
    The best overall response rate is defined as the percentage of patients having achieved confirmed Complete Response + Partial Response. Complete Response (CR) = at least two determinations of CR at least 4 weeks apart before progression. • Partial response (PR) = at least two determinations of PR or better at least 4 weeks apart before progression.
    time origin
    Time from randomisation to dates of disease progression, death from any cause or last tumor assessment, reported between day of first patient randomised, 10 January 2007, until cut-off date 02 April 2010
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The Full Analysis Set (FAS; Intent-to-treat Population) consists of all randomized patients.
    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
    NCT00412061
    outcome key
    om-0002
    source section id
    NCT00412061-om-0002
    source outcome index
    2
    endpoint
    Progression Free Survival (PFS) as Per Adjudicated Central Review by Baseline 5-hydroxyindoleacetic Acid (5-HIAA) Level
    endpoint definition
    5-HIAA levels in urine are frequently elevated in patients with advanced carcinoid tumors. Baseline levels of 5-HIAA in urine were defined as 'High' if they exceeded the median value, and 'Low' if they were lower than or equal to the median.
    time origin
    If elevated at baseline, evaluated every cycle visit (28 days/cycle) reported between day of first patient randomised, 10 January 2007, until cut-off date 02 April 2010
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The Full Analysis Set (FAS; Intent-to-treat Population) consists of all randomized patients. This analysis includes PFS patients with non missing baseline 5-HIAA data.
    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
    NCT00412061
    outcome key
    om-0003
    source section id
    NCT00412061-om-0003
    source outcome index
    3
    endpoint
    Overall Survival Using Kaplan-Meier Methodology
    endpoint definition
    Overall survival was defined as the time from the date of randomization to the date of death from any cause. If a patient was not known to have died, survival was censored at the date of last contact. Kaplan-Meier methodology was used to estimate the median overall survival for each treatment group.
    time origin
    Months 12, 24, 36, 48
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The Full Analysis Set (FAS; Intent-to-treat Population) consists of all randomized patients.
    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
    NCT00412061
    outcome key
    om-0004
    source section id
    NCT00412061-om-0004
    source outcome index
    4
    endpoint
    Number of Patients With Adverse Events (AEs), Clinically Notable AE, Death, Serious Adverse Events (SAEs) (Double-Blind Phase)
    endpoint definition
    AEs are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. SAEs are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.
    time origin
    From first day of treatment up to 28 days after last day of treatment in double blind
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The Safety Set consists of all patients who received at least one dose of study drug and who had at least one valid post-baseline safety assessment.
    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
    NCT00412061
    outcome key
    om-0005
    source section id
    NCT00412061-om-0005
    source outcome index
    5
    endpoint
    Number of Patients With Adverse Events (AEs), Clinically Notable AE, Death, Serious Adverse Events (SAEs) (Open Label Phase)
    endpoint definition
    AEs are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. SAEs are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgment of investigators represent significant hazards.
    time origin
    From first day of treatment up to 28 days after last day of treatment in double blind
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    The Safety Set consists of all patients who received at least one dose of study drug and who had at least one valid post-baseline safety assessment.
    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
    NCT00412061
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Octreotide+ Everolimus
    regimen
    Everolimus was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity. Each treatment cycle lasted 28 days. Patients received their first dose of everolimus at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1, Day 1.
    analyzed count
    216
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00412061-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroendocrine-tumor
    nct id
    NCT00412061
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Octreotide+ Placebo
    regimen
    Matching placebo was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity; Each treatment cycle lasted 28 days. Patients received their first dose of matching placebo at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1 Day 1.
    analyzed count
    213
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00412061-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroendocrine-tumor
    nct id
    NCT00412061
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Octreotide+ Everolimus
    regimen
    Everolimus was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity. Each treatment cycle lasted 28 days. Patients received their first dose of everolimus at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1, Day 1.
    analyzed count
    216
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00412061-om-0001#groups/OG000
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroendocrine-tumor
    nct id
    NCT00412061
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Octreotide+ Placebo
    regimen
    Matching placebo was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity; Each treatment cycle lasted 28 days. Patients received their first dose of matching placebo at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1 Day 1.
    analyzed count
    213
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00412061-om-0001#groups/OG001
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroendocrine-tumor
    nct id
    NCT00412061
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Octreotide+ Everolimus
    regimen
    Everolimus was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity. Each treatment cycle lasted 28 days. Patients received their first dose of everolimus at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1, Day 1.
    analyzed count
    187
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00412061-om-0002#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroendocrine-tumor
    nct id
    NCT00412061
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Octreotide+ Placebo
    regimen
    Matching placebo was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity; Each treatment cycle lasted 28 days. Patients received their first dose of matching placebo at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1 Day 1.
    analyzed count
    191
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00412061-om-0002#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroendocrine-tumor
    nct id
    NCT00412061
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Octreotide+ Everolimus
    regimen
    Everolimus was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity. Each treatment cycle lasted 28 days. Patients received their first dose of everolimus at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1, Day 1.
    analyzed count
    216
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00412061-om-0003#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroendocrine-tumor
    nct id
    NCT00412061
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Octreotide+ Placebo Followed by Open Label Arm
    regimen
    Matching placebo was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity; Each treatment cycle lasted 28 days. Patients received their first dose of matching placebo at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1 Day 1. Open Label - Patients who had progressive disease in this arm, can move to the open label Everolimus + depot octreotide by choice.
    analyzed count
    213
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00412061-om-0003#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroendocrine-tumor
    nct id
    NCT00412061
    outcome key
    om-0004
    arm key
    OG000
    arm label
    Octreotide+ Everolimus
    regimen
    Everolimus was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity. Each treatment cycle lasted 28 days. Patients received their first dose of everolimus at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1, Day 1.
    analyzed count
    215
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00412061-om-0004#groups/OG000
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroendocrine-tumor
    nct id
    NCT00412061
    outcome key
    om-0004
    arm key
    OG001
    arm label
    Octreotide+ Placebo
    regimen
    Matching placebo was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity; Each treatment cycle lasted 28 days. Patients received their first dose of matching placebo at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1 Day 1.
    analyzed count
    211
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00412061-om-0004#groups/OG001
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroendocrine-tumor
    nct id
    NCT00412061
    outcome key
    om-0005
    arm key
    OG000
    arm label
    Everolimus Open Label Arm
    regimen
    Patients who had progressive disease in this arm, can move to the open label Everolimus + depot octreotide by choice.
    analyzed count
    170
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT00412061-om-0005#groups/OG000
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroendocrine-tumor
    nct id
    NCT00412061
    harm key
    EG000
    source section id
    NCT00412061-ae
    event group key
    EG000
    event group label
    Everolimus + Octreotide
    serious affected
    126
    serious at risk
    215
    other affected
    214
    other at risk
    215
    frequency threshold
    5
    collection period
    Source null
    event definition
    Double blind period, Safety Set consists all patients received at least one dose of study drug and who had at least one valid post-baseline safety assessment. The Open-label Set consists all patients received at least one dose of open-label everolimus and who had at least one valid safety assessment after initiation of open-label treatment
    undenominated note
    Source null
    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
    NCT00412061
    harm key
    EG001
    source section id
    NCT00412061-ae
    event group key
    EG001
    event group label
    Placebo + Octreotide
    serious affected
    74
    serious at risk
    211
    other affected
    194
    other at risk
    211
    frequency threshold
    5
    collection period
    Source null
    event definition
    Double blind period, Safety Set consists all patients received at least one dose of study drug and who had at least one valid post-baseline safety assessment. The Open-label Set consists all patients received at least one dose of open-label everolimus and who had at least one valid safety assessment after initiation of open-label treatment
    undenominated note
    Source null
    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
    NCT00412061
    harm key
    EG002
    source section id
    NCT00412061-ae
    event group key
    EG002
    event group label
    Everolimus Open Label
    serious affected
    93
    serious at risk
    170
    other affected
    162
    other at risk
    170
    frequency threshold
    5
    collection period
    Source null
    event definition
    Double blind period, Safety Set consists all patients received at least one dose of study drug and who had at least one valid post-baseline safety assessment. The Open-label Set consists all patients received at least one dose of open-label everolimus and who had at least one valid safety assessment after initiation of open-label treatment
    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