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
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.
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
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).
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)
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)
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)
Reported safety
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
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
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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
Triangle