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← Neuroendocrine Tumor

NCT02299089 · STUDY IN CONTEXT

Phase II Study of Subcutaneous Inj. Depot of Octreotide in Patients With Acromegaly and Neuroendocrine Tumours (NETs)

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

Pharmacokinetics (PK) of octreotide after injection of Sandostatin Long-acting Release (LAR) was determined for the dosing period Day -28 to Day 0; AUC0-28d (day\*ng/mL). AUC0-28d: AUC from 0 to 28 days over the final dosing interval (day\*ng/mL) for Sandostatin LAR.

Pharmacokinetic population

→

primary · POSTED

Pharmacokinetics (PK) of octreotide after administrations of CAM2029 was determined for the dosing period Day 0 to Day 84 ; AUC0-28d (day\*ng/mL). AUC0-28d: AUC from 0 to 28 days over the dosing intervals (day\*ng/mL) for CAM2029 20 mg q4w and CAM2029 10 mg q2w (to estimate AUC0-28d for those patients receiving CAM2029 10 mg q2w, AUC0-14d was multiplied by a factor of 2 as an estimate of the AUC0-28d) dosing intervals

Pharmacokinetic population, two patients excluded from the CAM2029 20mg Acromegaly due to incorrect dose.

→

primary · POSTED

Pharmacokinetics (PK) of octreotide after injection of Sandostatin Long-acting Release (LAR) was determined for the dosing period Day -28 to Day 0; Ctrough (ng/mL). Ctrough; Concentration levels assessed prior to next injection for the final (Sandostatin LAR) dosing interval (ng/mL).

Pharmacokinetic population

→

primary · POSTED

Pharmacokinetics (PK) of octreotide after injection of Sandostatin Long-acting Release (LAR) was determined for the dosing period Day -28 to Day 0; Cmax (ng/mL). Cmax (ng/mL): Maximum observed plasma concentration over the final (Sandostatin LAR) dosing interval (ng/mL)

Pharmacokinetic population

→

primary · POSTED

Pharmacokinetics (PK) of octreotide after administrations of CAM2029 was determined for the dosing period Day 0 to Day 84; Ctrough (ng/mL). Ctrough; Concentration levels assessed prior to next injection for CAM2029 20 mg q4w and CAM2029 10 mg q2w dosing intervals (ng/mL)

Pharmacokinetic population, two patients excluded from the CAM2029 20mg Acromegaly due to incorrect dose.

→

primary · POSTED

Pharmacokinetics (PK) of octreotide after administrations of CAM2029 was determined for the dosing period Day 0 to Day 84 ; Cmax (ng/mL). Cmax (ng/mL): Maximum observed plasma concentration over CAM2029 20 mg q4w and CAM2029 10 mg q2w dosing intervals (ng/mL)

Pharmacokinetic population, two patients excluded from the CAM2029 20mg Acromegaly due to incorrect dose.

→

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 · Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) AUC.

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
NCT02299089
qol key
qol-0001
source section id
NCT02299089-om-0001
source outcome index
1
instrument
FACT
instrument basis
matched 'factor' in the study's own wording
scale title
Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) AUC.
measure definition
Pharmacokinetics (PK) of octreotide after administrations of CAM2029 was determined for the dosing period Day 0 to Day 84 ; AUC0-28d (day\*ng/mL). AUC0-28d: AUC from 0 to 28 days over the dosing intervals (day\*ng/mL) for CAM2029 20 mg q4w and CAM2029 10 mg q2w (to estimate AUC0-28d for those patients receiving CAM2029 10 mg q2w, AUC0-14d was multiplied by a factor of 2 as an estimate of the AUC0-28d) dosing intervals
time frame
(Day 0) to Day 84 (PK analysis:CAM2029 sampling time points: CAM2029 10mg q2w; 0, 2hours, 24hours, 48hours, 7days and 14days CAM2029 20mg q4w; 0, 2hours, 24hours, 48hours, 7days, 21days and 28days)
analysis role
primary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Pharmacokinetic population, two patients excluded from the CAM2029 20mg Acromegaly due to incorrect dose.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
FACT · CAM2029 Effect on Insulin-like Growth Factor (IGF-1) (Acromegaly)

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
NCT02299089
qol key
qol-0007
source section id
NCT02299089-om-0007
source outcome index
7
instrument
FACT
instrument basis
matched 'factor' in the study's own wording
scale title
CAM2029 Effect on Insulin-like Growth Factor (IGF-1) (Acromegaly)
measure definition
Data is presented as number of patients * Within the reference limits (see below) * Above ULN (Upper Limits of Normal) In the Acromegaly group both males and females were included the age was between 42-70 years. The IGF normal range for the different genders and age are presented below. REFERENCE VALUES Males (NMOL/L) 8.34-27.44 (41-45 years) 7.7-26.36 (46-50 years) 7.3-26.34 (51-55 years) 6.64-25.44 (56-60 years) 6.17-25.02 (61-65 years) 5.96-25.48 (66-70 years) Females (NMOL/L) 8.06-26.89 (41-45 years) 7.39-25.44 (46-50 years) 6.92-24.98 (51-55 years) 5.92-22.7 (56-60 years) 5.42-21.96 (61-65 years) 5.07-21.97 (66-70 years)
time frame
Day 84
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Pharmacokinetic population (5 acromegaly subjects total)
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
NCT02299089
trial label
Phase II Study of Subcutaneous Inj. Depot of Octreotide in Patients With Acromegaly and Neuroendocrine Tumours (NETs)
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
6
qol Count
2
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroendocrine-tumor
    nct id
    NCT02299089
    outcome key
    om-0000
    source section id
    NCT02299089-om-0000
    source outcome index
    0
    endpoint
    Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) AUC
    endpoint definition
    Pharmacokinetics (PK) of octreotide after injection of Sandostatin Long-acting Release (LAR) was determined for the dosing period Day -28 to Day 0; AUC0-28d (day\*ng/mL). AUC0-28d: AUC from 0 to 28 days over the final dosing interval (day\*ng/mL) for Sandostatin LAR.
    time origin
    Pre-dose; study Day -28- to Day 0 (PK analysis:Sandostatin (LAR®) sampling time points: 0, 1hour, 24hours, 7days, 14days, 21days and 28days)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Pharmacokinetic population
    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
    NCT02299089
    outcome key
    om-0001
    source section id
    NCT02299089-om-0001
    source outcome index
    1
    endpoint
    Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) AUC.
    endpoint definition
    Pharmacokinetics (PK) of octreotide after administrations of CAM2029 was determined for the dosing period Day 0 to Day 84 ; AUC0-28d (day\*ng/mL). AUC0-28d: AUC from 0 to 28 days over the dosing intervals (day\*ng/mL) for CAM2029 20 mg q4w and CAM2029 10 mg q2w (to estimate AUC0-28d for those patients receiving CAM2029 10 mg q2w, AUC0-14d was multiplied by a factor of 2 as an estimate of the AUC0-28d) dosing intervals
    time origin
    (Day 0) to Day 84 (PK analysis:CAM2029 sampling time points: CAM2029 10mg q2w; 0, 2hours, 24hours, 48hours, 7days and 14days CAM2029 20mg q4w; 0, 2hours, 24hours, 48hours, 7days, 21days and 28days)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Pharmacokinetic population, two patients excluded from the CAM2029 20mg Acromegaly due to incorrect dose.
    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
    NCT02299089
    outcome key
    om-0002
    source section id
    NCT02299089-om-0002
    source outcome index
    2
    endpoint
    Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) Ctrough
    endpoint definition
    Pharmacokinetics (PK) of octreotide after injection of Sandostatin Long-acting Release (LAR) was determined for the dosing period Day -28 to Day 0; Ctrough (ng/mL). Ctrough; Concentration levels assessed prior to next injection for the final (Sandostatin LAR) dosing interval (ng/mL).
    time origin
    Pre-dose; study Day -28- to Day 0 (PK analysis:Sandostatin (LAR®) sampling time points: 0, 1hour, 24hours, 7days, 14days, 21days and 28days)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Pharmacokinetic population
    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
    NCT02299089
    outcome key
    om-0003
    source section id
    NCT02299089-om-0003
    source outcome index
    3
    endpoint
    Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) Cmax
    endpoint definition
    Pharmacokinetics (PK) of octreotide after injection of Sandostatin Long-acting Release (LAR) was determined for the dosing period Day -28 to Day 0; Cmax (ng/mL). Cmax (ng/mL): Maximum observed plasma concentration over the final (Sandostatin LAR) dosing interval (ng/mL)
    time origin
    Pre-dose; study Day -28- to Day 0 (PK analysis:Sandostatin (LAR®) sampling time points: 0, 1hour, 24hours, 7days, 14days, 21days and 28days)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Pharmacokinetic population
    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
    NCT02299089
    outcome key
    om-0004
    source section id
    NCT02299089-om-0004
    source outcome index
    4
    endpoint
    Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) Ctrough
    endpoint definition
    Pharmacokinetics (PK) of octreotide after administrations of CAM2029 was determined for the dosing period Day 0 to Day 84; Ctrough (ng/mL). Ctrough; Concentration levels assessed prior to next injection for CAM2029 20 mg q4w and CAM2029 10 mg q2w dosing intervals (ng/mL)
    time origin
    (Day 0) to Day 84 (PK analysis:CAM2029 sampling time points: CAM2029 10mg q2w; 0, 2hours, 24hours, 48hours, 7days and 14days CAM2029 20mg q4w; 0, 2hours, 24hours, 48hours, 7days, 21days and 28days)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Pharmacokinetic population, two patients excluded from the CAM2029 20mg Acromegaly due to incorrect dose.
    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
    NCT02299089
    outcome key
    om-0005
    source section id
    NCT02299089-om-0005
    source outcome index
    5
    endpoint
    Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) Cmax.
    endpoint definition
    Pharmacokinetics (PK) of octreotide after administrations of CAM2029 was determined for the dosing period Day 0 to Day 84 ; Cmax (ng/mL). Cmax (ng/mL): Maximum observed plasma concentration over CAM2029 20 mg q4w and CAM2029 10 mg q2w dosing intervals (ng/mL)
    time origin
    (Day 0) to Day 84 (PK analysis:CAM2029 sampling time points: CAM2029 10mg q2w; 0, 2hours, 24hours, 48hours, 7days and 14days CAM2029 20mg q4w; 0, 2hours, 24hours, 48hours, 7days, 21days and 28days)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Pharmacokinetic population, two patients excluded from the CAM2029 20mg Acromegaly due to incorrect dose.
    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
    NCT02299089
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Sandostatin LAR 10 mg (Acromegaly)
    regimen
    Study injection (period 0) pre-CAM2029 treatment (day -28 to D0) of their ongoing maintenance therapy with Sandostatin LAR
    analyzed count
    1
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02299089-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroendocrine-tumor
    nct id
    NCT02299089
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Sandostatin LAR 30mg (Acromegaly)
    regimen
    Study injection (period 0) pre-CAM2029 treatment (day -28 to D0) of their ongoing maintenance therapy with Sandostatin LAR
    analyzed count
    4
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02299089-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroendocrine-tumor
    nct id
    NCT02299089
    outcome key
    om-0000
    arm key
    OG002
    arm label
    Sandostatin LAR 20 mg (NET)
    regimen
    Study injection (period 0) pre-CAM2029 treatment (day -28 to D0) of their ongoing maintenance therapy with Sandostatin LAR
    analyzed count
    1
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02299089-om-0000#groups/OG002
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroendocrine-tumor
    nct id
    NCT02299089
    outcome key
    om-0000
    arm key
    OG003
    arm label
    Sandostatin LAR 30 mg (NET)
    regimen
    Study injection (period 0) pre-CAM2029 treatment (day -28 to D0) of their ongoing maintenance therapy with Sandostatin LAR
    analyzed count
    4
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02299089-om-0000#groups/OG003
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroendocrine-tumor
    nct id
    NCT02299089
    outcome key
    om-0001
    arm key
    OG000
    arm label
    CAM2029 10 mg q2w (Acromegaly)
    regimen
    CAM2029 (octreotide FluidCrystal® injection depot) 10 mg, subcutaneous injection every two weeks octreotide FluidCrystal® injection depot
    analyzed count
    3
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02299089-om-0001#groups/OG000
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroendocrine-tumor
    nct id
    NCT02299089
    outcome key
    om-0001
    arm key
    OG001
    arm label
    CAM2029 20 mg q4w (Acromegaly)
    regimen
    CAM2029 (octreotide FluidCrystal® injection depot) 20 mg, subcutaneous injection once monthly octreotide FluidCrystal® injection depot
    analyzed count
    2
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02299089-om-0001#groups/OG001
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroendocrine-tumor
    nct id
    NCT02299089
    outcome key
    om-0001
    arm key
    OG002
    arm label
    CAM2029 10 mg q2w (NET)
    regimen
    CAM2029 (octreotide FluidCrystal® injection depot) 10 mg, subcutaneous injection every two weeks octreotide FluidCrystal® injection depot
    analyzed count
    1
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02299089-om-0001#groups/OG002
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroendocrine-tumor
    nct id
    NCT02299089
    outcome key
    om-0001
    arm key
    OG003
    arm label
    CAM2029 20 mg q4w (NET)
    regimen
    CAM2029 (octreotide FluidCrystal® injection depot) 20 mg, subcutaneous injection once monthly octreotide FluidCrystal® injection depot
    analyzed count
    4
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02299089-om-0001#groups/OG003
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroendocrine-tumor
    nct id
    NCT02299089
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Sandostatin LAR 10 mg (Acromegaly)
    regimen
    Study injection (period 0) pre-CAM2029 treatment (day -28 to D0) of their ongoing maintenance therapy with Sandostatin LAR
    analyzed count
    1
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02299089-om-0002#groups/OG000
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroendocrine-tumor
    nct id
    NCT02299089
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Sandostatin LAR 30mg (Acromegaly)
    regimen
    Study injection (period 0) pre-CAM2029 treatment (day -28 to D0) of their ongoing maintenance therapy with Sandostatin LAR
    analyzed count
    4
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02299089-om-0002#groups/OG001
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroendocrine-tumor
    nct id
    NCT02299089
    outcome key
    om-0002
    arm key
    OG002
    arm label
    Sandostatin LAR 20 mg (NET)
    regimen
    Study injection (period 0) pre-CAM2029 treatment (day -28 to D0) of their ongoing maintenance therapy with Sandostatin LAR
    analyzed count
    1
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02299089-om-0002#groups/OG002
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroendocrine-tumor
    nct id
    NCT02299089
    outcome key
    om-0002
    arm key
    OG003
    arm label
    Sandostatin LAR 30 mg (NET)
    regimen
    Study injection (period 0) pre-CAM2029 treatment (day -28 to D0) of their ongoing maintenance therapy with Sandostatin LAR
    analyzed count
    3
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT02299089-om-0002#groups/OG003
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroendocrine-tumor
    nct id
    NCT02299089
    harm key
    EG000
    source section id
    NCT02299089-ae
    event group key
    EG000
    event group label
    CAM2029 10 mg q2w (Acromegaly)
    serious affected
    0
    serious at risk
    3
    other affected
    2
    other at risk
    3
    frequency threshold
    0
    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
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroendocrine-tumor
    nct id
    NCT02299089
    harm key
    EG001
    source section id
    NCT02299089-ae
    event group key
    EG001
    event group label
    CAM2029 20 mg q4w (Acormegaly)
    serious affected
    0
    serious at risk
    4
    other affected
    4
    other at risk
    4
    frequency threshold
    0
    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
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroendocrine-tumor
    nct id
    NCT02299089
    harm key
    EG002
    source section id
    NCT02299089-ae
    event group key
    EG002
    event group label
    CAM2029 10 mg q2w (NET)
    serious affected
    0
    serious at risk
    1
    other affected
    0
    other at risk
    1
    frequency threshold
    0
    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
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroendocrine-tumor
    nct id
    NCT02299089
    harm key
    EG003
    source section id
    NCT02299089-ae
    event group key
    EG003
    event group label
    CAM2029 20 mg q4w (NET)
    serious affected
    1
    serious at risk
    4
    other affected
    2
    other at risk
    4
    frequency threshold
    0
    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
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroendocrine-tumor
    nct id
    NCT02299089
    harm key
    EG004
    source section id
    NCT02299089-ae
    event group key
    EG004
    event group label
    Sandostatin LAR (Acromegaly)
    serious affected
    0
    serious at risk
    7
    other affected
    4
    other at risk
    7
    frequency threshold
    0
    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
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroendocrine-tumor
    nct id
    NCT02299089
    harm key
    EG005
    source section id
    NCT02299089-ae
    event group key
    EG005
    event group label
    Sandostatin LAR (NET)
    serious affected
    0
    serious at risk
    5
    other affected
    2
    other at risk
    5
    frequency threshold
    0
    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
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-neuroendocrine-tumor
    nct id
    NCT02299089
    qol key
    qol-0001
    source section id
    NCT02299089-om-0001
    source outcome index
    1
    instrument
    FACT
    instrument basis
    matched 'factor' in the study's own wording
    scale title
    Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) AUC.
    measure definition
    Pharmacokinetics (PK) of octreotide after administrations of CAM2029 was determined for the dosing period Day 0 to Day 84 ; AUC0-28d (day\*ng/mL). AUC0-28d: AUC from 0 to 28 days over the dosing intervals (day\*ng/mL) for CAM2029 20 mg q4w and CAM2029 10 mg q2w (to estimate AUC0-28d for those patients receiving CAM2029 10 mg q2w, AUC0-14d was multiplied by a factor of 2 as an estimate of the AUC0-28d) dosing intervals
    time frame
    (Day 0) to Day 84 (PK analysis:CAM2029 sampling time points: CAM2029 10mg q2w; 0, 2hours, 24hours, 48hours, 7days and 14days CAM2029 20mg q4w; 0, 2hours, 24hours, 48hours, 7days, 21days and 28days)
    analysis role
    primary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Pharmacokinetic population, two patients excluded from the CAM2029 20mg Acromegaly due to incorrect dose.
    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
    NCT02299089
    qol key
    qol-0007
    source section id
    NCT02299089-om-0007
    source outcome index
    7
    instrument
    FACT
    instrument basis
    matched 'factor' in the study's own wording
    scale title
    CAM2029 Effect on Insulin-like Growth Factor (IGF-1) (Acromegaly)
    measure definition
    Data is presented as number of patients * Within the reference limits (see below) * Above ULN (Upper Limits of Normal) In the Acromegaly group both males and females were included the age was between 42-70 years. The IGF normal range for the different genders and age are presented below. REFERENCE VALUES Males (NMOL/L) 8.34-27.44 (41-45 years) 7.7-26.36 (46-50 years) 7.3-26.34 (51-55 years) 6.64-25.44 (56-60 years) 6.17-25.02 (61-65 years) 5.96-25.48 (66-70 years) Females (NMOL/L) 8.06-26.89 (41-45 years) 7.39-25.44 (46-50 years) 6.92-24.98 (51-55 years) 5.92-22.7 (56-60 years) 5.42-21.96 (61-65 years) 5.07-21.97 (66-70 years)
    time frame
    Day 84
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Pharmacokinetic population (5 acromegaly subjects total)
    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