Trial Outcomes & Findings for Phase II Study of Subcutaneous Inj. Depot of Octreotide in Patients With Acromegaly and Neuroendocrine Tumours (NETs) (NCT NCT02299089)
NCT ID: NCT02299089
Last Updated: 2017-12-15
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
12 participants
Primary outcome timeframe
Pre-dose; study Day -28- to Day 0 (PK analysis:Sandostatin (LAR®) sampling time points: 0, 1hour, 24hours, 7days, 14days, 21days and 28days)
Results posted on
2017-12-15
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
4
|
1
|
4
|
|
Overall Study
COMPLETED
|
3
|
4
|
1
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase II Study of Subcutaneous Inj. Depot of Octreotide in Patients With Acromegaly and Neuroendocrine Tumours (NETs)
Baseline characteristics by cohort
| Measure |
CAM2029 10 mg q2w (Acromegaly)
n=3 Participants
CAM2029 (octreotide FluidCrystal® injection depot) 10 mg, subcutaneous injection every two weeks
octreotide FluidCrystal® injection depot
|
CAM2029 20 mg q4w (Acromegaly)
n=4 Participants
CAM2029 (octreotide FluidCrystal® injection depot) 20 mg, subcutaneous injection once monthly
octreotide FluidCrystal® injection depot
|
CAM2029 10 mg q2w (NET)
n=1 Participants
CAM2029 (octreotide FluidCrystal® injection depot) 10 mg, subcutaneous injection every two weeks
octreotide FluidCrystal® injection depot
|
CAM2029 20 mg q4w (NET)
n=4 Participants
CAM2029 (octreotide FluidCrystal® injection depot) 20 mg, subcutaneous injection once monthly
octreotide FluidCrystal® injection depot
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Age, Continuous
|
59 years
STANDARD_DEVIATION 14.93 • n=5 Participants
|
62.5 years
STANDARD_DEVIATION 4.80 • n=7 Participants
|
59 years
STANDARD_DEVIATION 0 • n=5 Participants
|
64.8 years
STANDARD_DEVIATION 4.11 • n=4 Participants
|
62.1 years
STANDARD_DEVIATION 7.59 • n=21 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Region of Enrollment
Italy
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
3 participants
n=21 Participants
|
|
Region of Enrollment
France
|
1 participants
n=5 Participants
|
3 participants
n=7 Participants
|
0 participants
n=5 Participants
|
1 participants
n=4 Participants
|
5 participants
n=21 Participants
|
|
Region of Enrollment
Germany
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
3 participants
n=4 Participants
|
4 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Pre-dose; study Day -28- to Day 0 (PK analysis:Sandostatin (LAR®) sampling time points: 0, 1hour, 24hours, 7days, 14days, 21days and 28days)Population: Pharmacokinetic population
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.
Outcome measures
| Measure |
Sandostatin LAR 10 mg (Acromegaly)
n=1 Participants
Study injection (period 0) pre-CAM2029 treatment (day -28 to D0) of their ongoing maintenance therapy with Sandostatin LAR
|
Sandostatin LAR 30mg (Acromegaly)
n=4 Participants
Study injection (period 0) pre-CAM2029 treatment (day -28 to D0) of their ongoing maintenance therapy with Sandostatin LAR
|
Sandostatin LAR 20 mg (NET)
n=1 Participants
Study injection (period 0) pre-CAM2029 treatment (day -28 to D0) of their ongoing maintenance therapy with Sandostatin LAR
|
Sandostatin LAR 30 mg (NET)
n=4 Participants
Study injection (period 0) pre-CAM2029 treatment (day -28 to D0) of their ongoing maintenance therapy with Sandostatin LAR
|
Sandostatin LAR (Acromegaly)
Period day -28 to day 0 All acromegaly patients and all treatment groups
|
Sandostain LAR (NET)
Period day-28 to 0 All NET patient and all treatment groups
|
|---|---|---|---|---|---|---|
|
Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) AUC
|
6.23 day*ng/mL
Standard Deviation NA
Single participant analyzed
|
24.1 day*ng/mL
Standard Deviation 11.6
|
27.8 day*ng/mL
Standard Deviation NA
Single participant analyzed
|
39.9 day*ng/mL
Standard Deviation 20.5
|
—
|
—
|
PRIMARY outcome
Timeframe: (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)Population: Pharmacokinetic population, two patients excluded from the CAM2029 20mg Acromegaly due to incorrect dose.
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
Outcome measures
| Measure |
Sandostatin LAR 10 mg (Acromegaly)
n=3 Participants
Study injection (period 0) pre-CAM2029 treatment (day -28 to D0) of their ongoing maintenance therapy with Sandostatin LAR
|
Sandostatin LAR 30mg (Acromegaly)
n=2 Participants
Study injection (period 0) pre-CAM2029 treatment (day -28 to D0) of their ongoing maintenance therapy with Sandostatin LAR
|
Sandostatin LAR 20 mg (NET)
n=1 Participants
Study injection (period 0) pre-CAM2029 treatment (day -28 to D0) of their ongoing maintenance therapy with Sandostatin LAR
|
Sandostatin LAR 30 mg (NET)
n=4 Participants
Study injection (period 0) pre-CAM2029 treatment (day -28 to D0) of their ongoing maintenance therapy with Sandostatin LAR
|
Sandostatin LAR (Acromegaly)
Period day -28 to day 0 All acromegaly patients and all treatment groups
|
Sandostain LAR (NET)
Period day-28 to 0 All NET patient and all treatment groups
|
|---|---|---|---|---|---|---|
|
Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) AUC.
AUC0-28d (day*ng/mL) Day 0
|
92.9 day*ng/mL
Standard Deviation 36.8
|
72.4 day*ng/mL
Standard Deviation 6.73
|
72.9 day*ng/mL
Standard Deviation NA
Single partcipant analyzed
|
135 day*ng/mL
Standard Deviation 37.8
|
—
|
—
|
|
Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) AUC.
AUC0-28d (day*ng/mL) Day 56
|
95.6 day*ng/mL
Standard Deviation 63.3
|
78.5 day*ng/mL
Standard Deviation 20.0
|
83.3 day*ng/mL
Standard Deviation NA
Single partcipant analyzed
|
135 day*ng/mL
Standard Deviation 34.7
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose; study Day -28- to Day 0 (PK analysis:Sandostatin (LAR®) sampling time points: 0, 1hour, 24hours, 7days, 14days, 21days and 28days)Population: Pharmacokinetic population
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).
Outcome measures
| Measure |
Sandostatin LAR 10 mg (Acromegaly)
n=1 Participants
Study injection (period 0) pre-CAM2029 treatment (day -28 to D0) of their ongoing maintenance therapy with Sandostatin LAR
|
Sandostatin LAR 30mg (Acromegaly)
n=4 Participants
Study injection (period 0) pre-CAM2029 treatment (day -28 to D0) of their ongoing maintenance therapy with Sandostatin LAR
|
Sandostatin LAR 20 mg (NET)
n=1 Participants
Study injection (period 0) pre-CAM2029 treatment (day -28 to D0) of their ongoing maintenance therapy with Sandostatin LAR
|
Sandostatin LAR 30 mg (NET)
n=3 Participants
Study injection (period 0) pre-CAM2029 treatment (day -28 to D0) of their ongoing maintenance therapy with Sandostatin LAR
|
Sandostatin LAR (Acromegaly)
Period day -28 to day 0 All acromegaly patients and all treatment groups
|
Sandostain LAR (NET)
Period day-28 to 0 All NET patient and all treatment groups
|
|---|---|---|---|---|---|---|
|
Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) Ctrough
|
0.225 ng/mL
Standard Deviation NA
Single participant analyzed
|
1.20 ng/mL
Standard Deviation 0.647
|
0.901 ng/mL
Standard Deviation NA
Single participant analyzed
|
1.27 ng/mL
Standard Deviation 0.480
|
—
|
—
|
PRIMARY outcome
Timeframe: Pre-dose; study Day -28- to Day 0 (PK analysis:Sandostatin (LAR®) sampling time points: 0, 1hour, 24hours, 7days, 14days, 21days and 28days)Population: Pharmacokinetic population
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)
Outcome measures
| Measure |
Sandostatin LAR 10 mg (Acromegaly)
n=1 Participants
Study injection (period 0) pre-CAM2029 treatment (day -28 to D0) of their ongoing maintenance therapy with Sandostatin LAR
|
Sandostatin LAR 30mg (Acromegaly)
n=4 Participants
Study injection (period 0) pre-CAM2029 treatment (day -28 to D0) of their ongoing maintenance therapy with Sandostatin LAR
|
Sandostatin LAR 20 mg (NET)
n=1 Participants
Study injection (period 0) pre-CAM2029 treatment (day -28 to D0) of their ongoing maintenance therapy with Sandostatin LAR
|
Sandostatin LAR 30 mg (NET)
n=4 Participants
Study injection (period 0) pre-CAM2029 treatment (day -28 to D0) of their ongoing maintenance therapy with Sandostatin LAR
|
Sandostatin LAR (Acromegaly)
Period day -28 to day 0 All acromegaly patients and all treatment groups
|
Sandostain LAR (NET)
Period day-28 to 0 All NET patient and all treatment groups
|
|---|---|---|---|---|---|---|
|
Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) Cmax
|
0.349 ng/mL
Standard Deviation NA
Single participant analyzed
|
1.41 ng/mL
Standard Deviation 0.693
|
1.68 ng/mL
Standard Deviation NA
Single participant analyzed
|
2.48 ng/mL
Standard Deviation 1.79
|
—
|
—
|
PRIMARY outcome
Timeframe: (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)Population: Pharmacokinetic population, two patients excluded from the CAM2029 20mg Acromegaly due to incorrect dose.
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)
Outcome measures
| Measure |
Sandostatin LAR 10 mg (Acromegaly)
n=3 Participants
Study injection (period 0) pre-CAM2029 treatment (day -28 to D0) of their ongoing maintenance therapy with Sandostatin LAR
|
Sandostatin LAR 30mg (Acromegaly)
n=2 Participants
Study injection (period 0) pre-CAM2029 treatment (day -28 to D0) of their ongoing maintenance therapy with Sandostatin LAR
|
Sandostatin LAR 20 mg (NET)
n=1 Participants
Study injection (period 0) pre-CAM2029 treatment (day -28 to D0) of their ongoing maintenance therapy with Sandostatin LAR
|
Sandostatin LAR 30 mg (NET)
n=4 Participants
Study injection (period 0) pre-CAM2029 treatment (day -28 to D0) of their ongoing maintenance therapy with Sandostatin LAR
|
Sandostatin LAR (Acromegaly)
Period day -28 to day 0 All acromegaly patients and all treatment groups
|
Sandostain LAR (NET)
Period day-28 to 0 All NET patient and all treatment groups
|
|---|---|---|---|---|---|---|
|
Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) Ctrough
Ctrough (ng/mL) Day 0
|
1.32 ng/ml
Standard Deviation 0.422
|
0.403 ng/ml
Standard Deviation 0.342
|
1.80 ng/ml
Standard Deviation NA
Single participant analyzed
|
1.81 ng/ml
Standard Deviation 0.817
|
—
|
—
|
|
Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) Ctrough
Ctrough (ng(mL) Day 56
|
1.03 ng/ml
Standard Deviation 0.223
|
1.01 ng/ml
Standard Deviation 0.365
|
1.27 ng/ml
Standard Deviation NA
Single participant analyzed
|
1.73 ng/ml
Standard Deviation 0.965
|
—
|
—
|
PRIMARY outcome
Timeframe: (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)Population: Pharmacokinetic population, two patients excluded from the CAM2029 20mg Acromegaly due to incorrect dose.
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)
Outcome measures
| Measure |
Sandostatin LAR 10 mg (Acromegaly)
n=3 Participants
Study injection (period 0) pre-CAM2029 treatment (day -28 to D0) of their ongoing maintenance therapy with Sandostatin LAR
|
Sandostatin LAR 30mg (Acromegaly)
n=2 Participants
Study injection (period 0) pre-CAM2029 treatment (day -28 to D0) of their ongoing maintenance therapy with Sandostatin LAR
|
Sandostatin LAR 20 mg (NET)
n=1 Participants
Study injection (period 0) pre-CAM2029 treatment (day -28 to D0) of their ongoing maintenance therapy with Sandostatin LAR
|
Sandostatin LAR 30 mg (NET)
n=4 Participants
Study injection (period 0) pre-CAM2029 treatment (day -28 to D0) of their ongoing maintenance therapy with Sandostatin LAR
|
Sandostatin LAR (Acromegaly)
Period day -28 to day 0 All acromegaly patients and all treatment groups
|
Sandostain LAR (NET)
Period day-28 to 0 All NET patient and all treatment groups
|
|---|---|---|---|---|---|---|
|
Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) Cmax.
Cmax (ng/mL) Day 0
|
10.4 ng/mL
Standard Deviation 6.62
|
13.4 ng/mL
Standard Deviation 4.31
|
6.33 ng/mL
Standard Deviation NA
Single participant analyzed
|
16.3 ng/mL
Standard Deviation 8.67
|
—
|
—
|
|
Pharmacokinetic (PK) Profile of Octreotide After Each Injection of CAM2029 as Compared With Baseline PK for Sandostatin® Long-acting Release (LAR®) Cmax.
Cmax (ng/mL) Day 56
|
10.6 ng/mL
Standard Deviation 10.2
|
11.3 ng/mL
Standard Deviation 2.58
|
5.61 ng/mL
Standard Deviation NA
Single participant analyzed
|
15.7 ng/mL
Standard Deviation 4.05
|
—
|
—
|
SECONDARY outcome
Timeframe: Day -28 to Day 84Population: Safety population (n=12). Patients treated with Sandostatin LAR Day -28 to 0 and CAM2029 (Day 0 to Day 84)
Safety (number of adverse events and serious adverse events) after repeated doses of CAM2029 (assessment period from Day 0 to Day 84) and single dose Sandostatin LAR (assessment period Day -28 to Day 0)
Outcome measures
| Measure |
Sandostatin LAR 10 mg (Acromegaly)
n=3 Participants
Study injection (period 0) pre-CAM2029 treatment (day -28 to D0) of their ongoing maintenance therapy with Sandostatin LAR
|
Sandostatin LAR 30mg (Acromegaly)
n=4 Participants
Study injection (period 0) pre-CAM2029 treatment (day -28 to D0) of their ongoing maintenance therapy with Sandostatin LAR
|
Sandostatin LAR 20 mg (NET)
n=1 Participants
Study injection (period 0) pre-CAM2029 treatment (day -28 to D0) of their ongoing maintenance therapy with Sandostatin LAR
|
Sandostatin LAR 30 mg (NET)
n=4 Participants
Study injection (period 0) pre-CAM2029 treatment (day -28 to D0) of their ongoing maintenance therapy with Sandostatin LAR
|
Sandostatin LAR (Acromegaly)
n=7 Participants
Period day -28 to day 0 All acromegaly patients and all treatment groups
|
Sandostain LAR (NET)
n=5 Participants
Period day-28 to 0 All NET patient and all treatment groups
|
|---|---|---|---|---|---|---|
|
Number of Adverse Events and Serious Adverse Events
|
2 Participants
|
4 Participants
|
0 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Day 84Population: Pharmacokinetic population (5 acromegaly subjects total)
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)
Outcome measures
| Measure |
Sandostatin LAR 10 mg (Acromegaly)
n=3 Participants
Study injection (period 0) pre-CAM2029 treatment (day -28 to D0) of their ongoing maintenance therapy with Sandostatin LAR
|
Sandostatin LAR 30mg (Acromegaly)
n=2 Participants
Study injection (period 0) pre-CAM2029 treatment (day -28 to D0) of their ongoing maintenance therapy with Sandostatin LAR
|
Sandostatin LAR 20 mg (NET)
Study injection (period 0) pre-CAM2029 treatment (day -28 to D0) of their ongoing maintenance therapy with Sandostatin LAR
|
Sandostatin LAR 30 mg (NET)
Study injection (period 0) pre-CAM2029 treatment (day -28 to D0) of their ongoing maintenance therapy with Sandostatin LAR
|
Sandostatin LAR (Acromegaly)
Period day -28 to day 0 All acromegaly patients and all treatment groups
|
Sandostain LAR (NET)
Period day-28 to 0 All NET patient and all treatment groups
|
|---|---|---|---|---|---|---|
|
CAM2029 Effect on Insulin-like Growth Factor (IGF-1) (Acromegaly)
Within Normal Limits
|
2 participants
|
1 participants
|
—
|
—
|
—
|
—
|
|
CAM2029 Effect on Insulin-like Growth Factor (IGF-1) (Acromegaly)
Above ULN
|
1 participants
|
1 participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 84Population: Pharmacokinetic population (5 acromegaly patients)
GH (growth hormone) levels measured on Day 84 in patients with acromegaly
Outcome measures
| Measure |
Sandostatin LAR 10 mg (Acromegaly)
n=3 Participants
Study injection (period 0) pre-CAM2029 treatment (day -28 to D0) of their ongoing maintenance therapy with Sandostatin LAR
|
Sandostatin LAR 30mg (Acromegaly)
n=2 Participants
Study injection (period 0) pre-CAM2029 treatment (day -28 to D0) of their ongoing maintenance therapy with Sandostatin LAR
|
Sandostatin LAR 20 mg (NET)
Study injection (period 0) pre-CAM2029 treatment (day -28 to D0) of their ongoing maintenance therapy with Sandostatin LAR
|
Sandostatin LAR 30 mg (NET)
Study injection (period 0) pre-CAM2029 treatment (day -28 to D0) of their ongoing maintenance therapy with Sandostatin LAR
|
Sandostatin LAR (Acromegaly)
Period day -28 to day 0 All acromegaly patients and all treatment groups
|
Sandostain LAR (NET)
Period day-28 to 0 All NET patient and all treatment groups
|
|---|---|---|---|---|---|---|
|
CAM2029 Effect on Growth Hormone (GH) (Acromegaly)
GH level < 2.5 μg/L
|
2 participants
|
2 participants
|
—
|
—
|
—
|
—
|
|
CAM2029 Effect on Growth Hormone (GH) (Acromegaly)
GH level >2.5 μg/L
|
1 participants
|
0 participants
|
—
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (Day 0), Day 84Population: Pharmacokinetic population
Number of bowel movements and flushing during period 0 and 1, data is presented as patients experience symptoms Bowel movement without flushing Bowel movement and flushing No Bowel movement or Flushing
Outcome measures
| Measure |
Sandostatin LAR 10 mg (Acromegaly)
n=1 Participants
Study injection (period 0) pre-CAM2029 treatment (day -28 to D0) of their ongoing maintenance therapy with Sandostatin LAR
|
Sandostatin LAR 30mg (Acromegaly)
n=4 Participants
Study injection (period 0) pre-CAM2029 treatment (day -28 to D0) of their ongoing maintenance therapy with Sandostatin LAR
|
Sandostatin LAR 20 mg (NET)
Study injection (period 0) pre-CAM2029 treatment (day -28 to D0) of their ongoing maintenance therapy with Sandostatin LAR
|
Sandostatin LAR 30 mg (NET)
Study injection (period 0) pre-CAM2029 treatment (day -28 to D0) of their ongoing maintenance therapy with Sandostatin LAR
|
Sandostatin LAR (Acromegaly)
Period day -28 to day 0 All acromegaly patients and all treatment groups
|
Sandostain LAR (NET)
Period day-28 to 0 All NET patient and all treatment groups
|
|---|---|---|---|---|---|---|
|
To Assess the Symptoms of Carcinoid Syndrome (Number of Bowel Movements and Flushing) and the Use of Rescue Medication Versus Baseline (by Using Patient Diaries) (NET)
Bowel movements without flushing
|
1 participants
|
0 participants
|
—
|
—
|
—
|
—
|
|
To Assess the Symptoms of Carcinoid Syndrome (Number of Bowel Movements and Flushing) and the Use of Rescue Medication Versus Baseline (by Using Patient Diaries) (NET)
No Bowel movement or Flushing
|
0 participants
|
2 participants
|
—
|
—
|
—
|
—
|
|
To Assess the Symptoms of Carcinoid Syndrome (Number of Bowel Movements and Flushing) and the Use of Rescue Medication Versus Baseline (by Using Patient Diaries) (NET)
Bowel movements with flushing
|
0 participants
|
2 participants
|
—
|
—
|
—
|
—
|
Adverse Events
CAM2029 10 mg q2w (Acromegaly)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
CAM2029 20 mg q4w (Acormegaly)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
CAM2029 10 mg q2w (NET)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
CAM2029 20 mg q4w (NET)
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Sandostatin LAR (Acromegaly)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Sandostatin LAR (NET)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CAM2029 10 mg q2w (Acromegaly)
n=3 participants at risk
CAM2029 (octreotide FluidCrystal® injection depot) 10 mg, subcutaneous injection every two weeks
octreotide FluidCrystal® injection depot Day 0-84
|
CAM2029 20 mg q4w (Acormegaly)
n=4 participants at risk
CAM2029 (octreotide FluidCrystal® injection depot) 20 mg, subcutaneous injection once monthly
octreotide FluidCrystal® injection depot Day 0-84
|
CAM2029 10 mg q2w (NET)
n=1 participants at risk
CAM2029 (octreotide FluidCrystal® injection depot) 10 mg, subcutaneous injection every two weeks
octreotide FluidCrystal® injection depot Day 0-84
|
CAM2029 20 mg q4w (NET)
n=4 participants at risk
CAM2029 (octreotide FluidCrystal® injection depot) 20 mg, subcutaneous injection once monthly
octreotide FluidCrystal® injection depot Day 0-84
|
Sandostatin LAR (Acromegaly)
n=7 participants at risk
Sandostatin LAR Day-28 to day 0 All acromegaly patients, all treatment groups
|
Sandostatin LAR (NET)
n=5 participants at risk
Sandostatin LAR Day -28 to day 0 All NET patients, all treatment groups
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Anastomotic ulcer hemorrhage
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/1
|
25.0%
1/4 • Number of events 1
|
0.00%
0/7
|
0.00%
0/5
|
Other adverse events
| Measure |
CAM2029 10 mg q2w (Acromegaly)
n=3 participants at risk
CAM2029 (octreotide FluidCrystal® injection depot) 10 mg, subcutaneous injection every two weeks
octreotide FluidCrystal® injection depot Day 0-84
|
CAM2029 20 mg q4w (Acormegaly)
n=4 participants at risk
CAM2029 (octreotide FluidCrystal® injection depot) 20 mg, subcutaneous injection once monthly
octreotide FluidCrystal® injection depot Day 0-84
|
CAM2029 10 mg q2w (NET)
n=1 participants at risk
CAM2029 (octreotide FluidCrystal® injection depot) 10 mg, subcutaneous injection every two weeks
octreotide FluidCrystal® injection depot Day 0-84
|
CAM2029 20 mg q4w (NET)
n=4 participants at risk
CAM2029 (octreotide FluidCrystal® injection depot) 20 mg, subcutaneous injection once monthly
octreotide FluidCrystal® injection depot Day 0-84
|
Sandostatin LAR (Acromegaly)
n=7 participants at risk
Sandostatin LAR Day-28 to day 0 All acromegaly patients, all treatment groups
|
Sandostatin LAR (NET)
n=5 participants at risk
Sandostatin LAR Day -28 to day 0 All NET patients, all treatment groups
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
1/3 • Number of events 1
|
25.0%
1/4 • Number of events 1
|
0.00%
0/1
|
0.00%
0/4
|
0.00%
0/7
|
20.0%
1/5 • Number of events 1
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/1
|
0.00%
0/4
|
0.00%
0/7
|
0.00%
0/5
|
|
Eye disorders
Eyelid disorder
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/1
|
0.00%
0/4
|
0.00%
0/7
|
0.00%
0/5
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/1
|
0.00%
0/4
|
0.00%
0/7
|
0.00%
0/5
|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/1
|
25.0%
1/4 • Number of events 1
|
0.00%
0/7
|
0.00%
0/5
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
33.3%
1/3 • Number of events 1
|
0.00%
0/4
|
0.00%
0/1
|
0.00%
0/4
|
0.00%
0/7
|
0.00%
0/5
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/3
|
25.0%
1/4 • Number of events 1
|
0.00%
0/1
|
0.00%
0/4
|
0.00%
0/7
|
0.00%
0/5
|
|
Gastrointestinal disorders
Diverticulum Intestinal
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/1
|
25.0%
1/4 • Number of events 1
|
0.00%
0/7
|
0.00%
0/5
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/1
|
25.0%
1/4 • Number of events 1
|
0.00%
0/7
|
0.00%
0/5
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/1
|
25.0%
1/4 • Number of events 1
|
0.00%
0/7
|
0.00%
0/5
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/1
|
25.0%
1/4 • Number of events 1
|
0.00%
0/7
|
0.00%
0/5
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/1
|
25.0%
1/4 • Number of events 1
|
0.00%
0/7
|
0.00%
0/5
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/1
|
25.0%
1/4 • Number of events 1
|
0.00%
0/7
|
0.00%
0/5
|
|
General disorders
Asthenia
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/1
|
25.0%
1/4 • Number of events 1
|
0.00%
0/7
|
0.00%
0/5
|
|
General disorders
Fatigue
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/1
|
25.0%
1/4 • Number of events 1
|
0.00%
0/7
|
0.00%
0/5
|
|
General disorders
General physical health deterioration
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/1
|
25.0%
1/4 • Number of events 1
|
0.00%
0/7
|
0.00%
0/5
|
|
General disorders
Injection site pain
|
0.00%
0/3
|
50.0%
2/4 • Number of events 2
|
0.00%
0/1
|
25.0%
1/4 • Number of events 1
|
0.00%
0/7
|
0.00%
0/5
|
|
Investigations
Weight decrease
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/1
|
25.0%
1/4 • Number of events 1
|
0.00%
0/7
|
0.00%
0/5
|
|
Metabolism and nutrition disorders
Decreased appetitie
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/1
|
25.0%
1/4 • Number of events 1
|
0.00%
0/7
|
0.00%
0/5
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/1
|
25.0%
1/4 • Number of events 1
|
14.3%
1/7 • Number of events 1
|
0.00%
0/5
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/1
|
25.0%
1/4 • Number of events 1
|
0.00%
0/7
|
0.00%
0/5
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/1
|
25.0%
1/4 • Number of events 1
|
0.00%
0/7
|
0.00%
0/5
|
|
Nervous system disorders
Headache
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/1
|
25.0%
1/4 • Number of events 1
|
0.00%
0/7
|
20.0%
1/5 • Number of events 1
|
|
Psychiatric disorders
Mood altered
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/1
|
25.0%
1/4 • Number of events 1
|
0.00%
0/7
|
0.00%
0/5
|
|
Vascular disorders
Hypertension
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/1
|
25.0%
1/4 • Number of events 1
|
0.00%
0/7
|
0.00%
0/5
|
|
Investigations
Insulin like growth factor increase
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/1
|
0.00%
0/4
|
14.3%
1/7 • Number of events 1
|
0.00%
0/5
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/1
|
0.00%
0/4
|
14.3%
1/7 • Number of events 1
|
0.00%
0/5
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/1
|
0.00%
0/4
|
14.3%
1/7 • Number of events 1
|
0.00%
0/5
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/3
|
0.00%
0/4
|
0.00%
0/1
|
0.00%
0/4
|
14.3%
1/7 • Number of events 1
|
0.00%
0/5
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60