NCT02299089 · OUTCOME

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

Phase II Study of Subcutaneous Inj. Depot of Octreotide in Patients With Acromegaly and Neuroendocrine Tumours (NETs) · Source last updated 2017-12-15

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: MEAN
Unit: day*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 ; 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

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 identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

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

AUC0-28d (day*ng/mL) Day 0

Analysis denominator · Participants

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)	3

Values in day*ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
CAM2029 10 mg q2w (Acromegaly)	92.9	36.8	Not reported	Not reported	Not reported
CAM2029 20 mg q4w (Acromegaly)	72.4	6.73	Not reported	Not reported	Not reported
CAM2029 10 mg q2w (NET)	72.9	NA	Not reported	Not reported	Single partcipant analyzed
CAM2029 20 mg q4w (NET)	135	37.8	Not reported	Not reported	Not reported

AUC0-28d (day*ng/mL) Day 56

Analysis denominator · Participants

Group	Source count
CAM2029 10 mg q2w (Acromegaly)	2
CAM2029 20 mg q4w (Acromegaly)	2
CAM2029 10 mg q2w (NET)	1
CAM2029 20 mg q4w (NET)	4

Values in day*ng/mL · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
CAM2029 10 mg q2w (Acromegaly)	95.6	63.3	Not reported	Not reported	Not reported
CAM2029 20 mg q4w (Acromegaly)	78.5	20.0	Not reported	Not reported	Not reported
CAM2029 10 mg q2w (NET)	83.3	NA	Not reported	Not reported	Single partcipant analyzed
CAM2029 20 mg q4w (NET)	135	34.7	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
36.8
value
92.9
group Id
OG001
spread
6.73
value
72.4
comment
Single partcipant analyzed
group Id
OG002
spread
NA
value
72.9
group Id
OG003
spread
37.8
value
135
denoms
counts
group Id
OG000
value
3
group Id
OG001
value
2
group Id
OG002
value
1
group Id
OG003
value
3
units
Participants
title
AUC0-28d (day*ng/mL) Day 0
categories
measurements
group Id
OG000
spread
63.3
value
95.6
group Id
OG001
spread
20.0
value
78.5
comment
Single partcipant analyzed
group Id
OG002
spread
NA
value
83.3
group Id
OG003
spread
34.7
value
135
denoms
counts
group Id
OG000
value
2
group Id
OG001
value
2
group Id
OG002
value
1
group Id
OG003
value
4
units
Participants
title
AUC0-28d (day*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

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®) AUC.

type

PRIMARY

unit Of Measure

day*ng/mL

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Preserved source evidence · Not medical advice