TriangleNCT02299089 · OUTCOME
Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) Ctrough
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- ng/ml
- Interval / dispersion
- Standard Deviation
- 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)
What was measured
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)
Analysis population: Pharmacokinetic population, two patients excluded from the CAM2029 20mg Acromegaly due to incorrect dose.
Groups in this outcome
CAM2029 10 mg q2w (Acromegaly)
CAM2029 (octreotide FluidCrystal® injection depot) 10 mg, subcutaneous injection every two weeks octreotide FluidCrystal® injection depot
CAM2029 20 mg q4w (Acromegaly)
CAM2029 (octreotide FluidCrystal® injection depot) 20 mg, subcutaneous injection once monthly octreotide FluidCrystal® injection depot
CAM2029 10 mg q2w (NET)
CAM2029 (octreotide FluidCrystal® injection depot) 10 mg, subcutaneous injection every two weeks octreotide FluidCrystal® injection depot
CAM2029 20 mg q4w (NET)
CAM2029 (octreotide FluidCrystal® injection depot) 20 mg, subcutaneous injection once monthly octreotide FluidCrystal® injection depot
| Group | Source count |
|---|---|
| CAM2029 10 mg q2w (Acromegaly) | 3 |
| CAM2029 20 mg q4w (Acromegaly) | 2 |
| CAM2029 10 mg q2w (NET) | 1 |
| CAM2029 20 mg q4w (NET) | 4 |
Reported measurements
Ctrough (ng/mL) Day 0
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| CAM2029 10 mg q2w (Acromegaly) | 1.32 | 0.422 | Not reported | Not reported | Not reported |
| CAM2029 20 mg q4w (Acromegaly) | 0.403 | 0.342 | Not reported | Not reported | Not reported |
| CAM2029 10 mg q2w (NET) | 1.80 | NA | Not reported | Not reported | Single participant analyzed |
| CAM2029 20 mg q4w (NET) | 1.81 | 0.817 | Not reported | Not reported | Not reported |
Ctrough (ng(mL) Day 56
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| CAM2029 10 mg q2w (Acromegaly) | 1.03 | 0.223 | Not reported | Not reported | Not reported |
| CAM2029 20 mg q4w (Acromegaly) | 1.01 | 0.365 | Not reported | Not reported | Not reported |
| CAM2029 10 mg q2w (NET) | 1.27 | NA | Not reported | Not reported | Single participant analyzed |
| CAM2029 20 mg q4w (NET) | 1.73 | 0.965 | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- spread
- 0.422
- value
- 1.32
- group Id
- OG001
- spread
- 0.342
- value
- 0.403
- comment
- Single participant analyzed
- group Id
- OG002
- spread
- NA
- value
- 1.80
- group Id
- OG003
- spread
- 0.817
- value
- 1.81
- title
- Ctrough (ng/mL) Day 0
- categories
- measurements
- group Id
- OG000
- spread
- 0.223
- value
- 1.03
- group Id
- OG001
- spread
- 0.365
- value
- 1.01
- comment
- Single participant analyzed
- group Id
- OG002
- spread
- NA
- value
- 1.27
- group Id
- OG003
- spread
- 0.965
- value
- 1.73
- title
- Ctrough (ng(mL) Day 56
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 2
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 4
- units
- Participants
- description
- 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)
- dispersion Type
- Standard Deviation
- groups
- description
- CAM2029 (octreotide FluidCrystal® injection depot) 10 mg, subcutaneous injection every two weeks octreotide FluidCrystal® injection depot
- id
- OG000
- title
- CAM2029 10 mg q2w (Acromegaly)
- description
- CAM2029 (octreotide FluidCrystal® injection depot) 20 mg, subcutaneous injection once monthly octreotide FluidCrystal® injection depot
- id
- OG001
- title
- CAM2029 20 mg q4w (Acromegaly)
- description
- CAM2029 (octreotide FluidCrystal® injection depot) 10 mg, subcutaneous injection every two weeks octreotide FluidCrystal® injection depot
- id
- OG002
- title
- CAM2029 10 mg q2w (NET)
- description
- CAM2029 (octreotide FluidCrystal® injection depot) 20 mg, subcutaneous injection once monthly octreotide FluidCrystal® injection depot
- id
- OG003
- title
- CAM2029 20 mg q4w (NET)
- param Type
- MEAN
- population Description
- Pharmacokinetic population, two patients excluded from the CAM2029 20mg Acromegaly due to incorrect dose.
- reporting Status
- POSTED
- 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)
- title
- Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) Ctrough
- type
- PRIMARY
- unit Of Measure
- ng/ml
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Preserved source evidence · Not medical advice